Mitral Valve InsufficiencyHRRNCT01940120

EVEREST II Pivotal Study High Risk Registry (HRR)

A study testing Percutaneous mitral valve repair using MitraClip implant in people with Mitral Valve Insufficiency and Mitral Valve Regurgitation, run by Abbott Medical Devices at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Prospective, multi-center, single arm registry. Clinical follow-up at discharge, 30 days, 6, 12, 18 and 24, months, and 3, 4 and 5 years. Concurrent Control (CC) group identified retrospectively from the patients screened for the HRR who did not enroll; patient survival determined at 12 months. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Mitral Valve Insufficiency, Mitral Valve Regurgitation, Mitral Valve Incompetence
What is being tested?: Percutaneous mitral valve repair using MitraClip implant
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 78 participants
Where: 2 sitesUnited States
Study dates: Feb 2007to Feb 2013
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Candidates for the high risk arm of the study must meet all of the following inclusion criteria:
Predicted procedural mortality risk calculated using the STS surgical risk calculator of ≥ 12% or in the judgment of the surgeon investigator the patient is considered a high risk surgical candidate due to the presence of one of the following indications:
Porcelain aorta or mobile ascending aortic atheroma
Post-radiation mediastinum
Previous mediastinitis
Functional MR with EF<40

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Over 75 years old with EF<40
Re-operation with patent grafts
Two or more prior chest surgeries
Hepatic cirrhosis i Three or more of the following STS high risk factors: i) Creatinine > 2.5 mg/dL ii) Prior chest surgery iii) Age over 75 iv) EF<35
Age 18 years or older.
Symptomatic moderate to severe (3+) or severe (4+) chronic mitral regurgitation (MR) and in the judgment of the investigator intervention to reduce MR is likely to provide symptomatic relief for the patient. MR is determined as defined in Appendix A of the EVEREST II study protocol. American Society of Anesthesiologists (ASA) physical status classification of ASA IV or lower.
The primary regurgitant jet originates from malcoaptation of the A2 and P2 scallops of the mitral valve.
Male or Female. Female subjects of childbearing potential must have a negative pregnancy test within seven (7) days before the procedure.
The subject or the subject's legal representative has been informed of the nature of the study and agrees to its provisions and has provided written informed consent as approved by the Institutional Review Board of the respective clinical site.
The subject and the treating physician agree that the subject will return for all required post-procedure follow-up visits.
Transseptal catheterization is determined to be feasible by the treating physician.

Who cannot join

Candidates will be excluded from the study if any of the following conditions are present:
Evidence of an acute myocardial infarction in the prior 2 weeks of the intended treatment (defined as: Q wave or non-Q wave infarction having creatine kinase (CK) enzymes ≥ two times (2X) the upper laboratory normal limit with the presence of a Creatine Kinase MB Isoenzyme (CKMB) elevated above the institution's upper limit of normal).
In the judgment of the Investigator, the femoral vein cannot accommodate a 24 F catheter or presence of ipsilateral deep vein thrombosis (DVT).
Ejection fraction < 20%, and/or end-systolic dimension > 60 mm as defined in Appendix A of the EVEREST II protocol.
Mitral valve orifice area < 4.0 cm2 as defined in Appendix A of the EVEREST II protocol.
If leaflet flail is present:

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Flail Width: the width of the flail segment is greater than or equal to 15 mm, as defined in Section 4.3 and Appendix A, or
Flail Gap: the flail gap is greater than or equal to 10 mm, as defined in Section 4.3 and Appendix A.
If leaflet tethering is present:
a). Coaptation Length: the vertical coaptation length is less than 2 mm, as defined in Section 4.3 and Appendix A.
Leaflet anatomy which may preclude clip implantation, proper clip positioning on the leaflets or sufficient reduction in MR. This may include:
Evidence of calcification in the grasping area of the A2 and/or P2 scallops
Presence of a significant cleft of A2 or P2 scallops
More than one anatomic criteria dimensionally near the exclusion limits
Bileaflet flail or severe bileaflet prolapse
Lack of both primary and secondary chordal support
Hemodynamic instability defined as systolic pressure < 90 mmHg without after load reduction or cardiogenic shock or the need for inotropic support or intra-aortic balloon pump.
Need for emergent or urgent surgery for any reason.
Prior mitral valve leaflet surgery or any currently implanted mechanical prosthetic mitral valve.
Echocardiographic evidence of intracardiac mass, thrombus or vegetation.
Active endocarditis or active rheumatic heart disease or leaflets degenerated from rheumatic diseased (i.e. noncompliant, perforated).
History of bleeding diathesis or coagulopathy or subject will refuse blood transfusions.
Active infections requiring current antibiotic therapy (if temporary illness, patients may enroll 2 weeks after discontinuation of antibiotics). Patients must be free from infection prior to treatment. Any required dental work should be completed a minimum of 3 weeks prior to treatment.
Intravenous drug abuse or suspected inability to adhere to follow-up.
Patients in whom transesophageal echocardiography (TEE) is contraindicated.
A known hypersensitivity or contraindication to study or
In the judgment of the Investigator, patients in whom the presence of a permanent pacemaker or pacing leads would interfere with placement of the test device or the placement of the test device would disrupt the leads.
Currently participating in an investigational drug or another device study that has not completed the primary endpoint or that clinically interferes with the current study endpoints. [Note: Trials requiring extended follow-up for products that were investigational, but have since become commercially available, are not considered investigational trials].

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Evanston Northwestern Healthcare 2650 Ridge Ave., Walgreen Bldg, 3rd Floor, Cardiology
Evanston, Illinois, 60201
The Care Group Heart Center 10590 N. Meridian, Ste. 300
Indianapolis, Indiana, 46290

Other trials in United States

About this study

Official title: A Study of the Evalve® Cardiovascular Valve Repair (MitraClip®) System Endovascular Valve Edge-to-Edge REpair STudy (EVEREST II) EVEREST II High Risk Registry

Prospective, multi-center, single arm registry. Clinical follow-up at discharge, 30 days, 6, 12, 18 and 24, months, and 3, 4 and 5 years.

Concurrent Control (CC) group identified retrospectively from the patients screened for the HRR who did not enroll; patient survival determined at 12 months. NCT00209274 (EVEREST II RCT) Intended use Percutaneous reduction of clinically significant mitral regurgitation in symptomatic patients who are considered to be high risk for operative mortality (high surgical risk).

Read the detailed description

The EVEREST II HRR is a single-arm prospective, multicenter clinical trial enrolling high surgical risk patients of the EVEREST II study (NCT00209274).

Patients were considered high surgical risk if either their Society of Thoracic Surgery (STS) predicted operative mortality risk was ≥ 12%, or the surgeon investigator determined the patient to be high risk (≥ 12% predicted operative mortality risk) due to the presence of, at a minimum, one of the following pre-specified risk factors:

Porcelain aorta or mobile ascending aortic atheroma
Post-radiation mediastinum
Previous mediastinitis
Functional MR with ejection fraction (EF) < 40%
Over 75 years old with EF < 40%
Prior re-operation with patent grafts
Two or more prior chest surgeries
Hepatic cirrhosis
Three or more of the following STS high risk factors:

Creatinine > 2.5 mg/dL ii. Prior chest surgery iii. Age over 75 iv. EF < 35%

Upon completion of enrollment in the HRR, a process was initiated to ensure patient consent to participate in a Concurrent Control (CC) group was in place. Patients were identified to determine survival through 12 months with current standard of care treatment.CC patients were derived from a cohort of patients screened for enrollment in the HRR,yet did not enroll. All patients had moderate-to-severe (3+) or severe (4+) MR based on transthoracic echocardiography (TTE). To be considered eligible for inclusion in the CC group, the patient had to be classified as high surgical risk using the same criteria used for the HRR. Upon follow-up with the clinical sites, it was determined that some of the initially identified patients with moderate-to-severe (3+) or severe (4+) MR met the criteria for high surgical risk. Of these patients, some were not included due to; lack of Institutional Review Board (IRB) approval at the site, lack of informed consent and unable to be contacted. The remaining patients make up the CC group.

Conditions: Mitral Valve Insufficiency, Mitral Valve Regurgitation, Mitral Valve Incompetence, Mitral Regurgitation, Mitral Insufficiency
Being tested: Percutaneous mitral valve repair using MitraClip implant
Keywords: Mitral Valve Insufficiency, Mitral Valve Regurgitation, Mitral Valve Incompetence, Mitral Regurgitation, Mitral Insufficiency, Mitral Valve, MR, Mitral Valve Prolapse, Edge to Edge (E2E), Alfieri Technique, MitraClip, Functional MR, Degenerative MR, Echocardiogram, Coronary Artery Disease (CAD), Heart Failure, Heart Attack, EVEREST, EVEREST I, EVEREST II
Medical subject headings: Mitral Valve Insufficiency, Mitral Valve Prolapse, Coronary Artery Disease, Heart Failure, Myocardial Infarction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Percutaneous mitral valve repair using MitraClip implantDevice
Also called MitraClip, MitraClip Implant
Procedure/Surgery: Mitral valve repair or replacement surgery Repair or replacement of mitral valve

Study groups in NCT01940120
Study group	Role	What they receive
High Risk Registry Arm	Experimental	Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant. Receives: Device: Percutaneous mitral valve repair using MitraClip implant

What is being measured

The primary outcome is the main question the study is designed to answer.

Composite Functional and Structural Measures - Freedom From Death
Defined as all causes of death for the primary safety Major Adverse Event (MAE) Endpoint. Death is further divided into 2 categories:
1. Cardiac death is defined as death due to any of the following:
2. Acute myocardial infarction.
3. Cardiac perforation/pericardial tamponade.
4. Arrhythmia or conduction abnormality.
5. Stroke within 30 days of the procedure or stroke suspected of being related to the procedure.
6. Death due to any complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.
7. Any death for which a cardiac cause cannot be excluded.
8. Non-cardiac death is defined as a death not due to cardiac causes (as defined above).
Measured: 12 months
Percentage of Participants With Freedom From Death and Mitral Regurgitation (MR) >2+
Kaplan-Meier estimated percentage of patients who are alive and have a mitral regurgitation severity grade of 2+ or less
Measured: 12 months
Number of Participants With Clinical Measures of Benefit-New York Heart Association (NYHA) Class
The major effectiveness endpoint is an assessment of multiple functional and structural measures of benefit including New York Heart Association (NYHA) Class.
Class I: Patients with cardiac disease but without resulting limitations of physical activity.
Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.
Class III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain.
Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased.
Measured: 30 days
Number of Participants With New York Heart Association (NYHA) Class
Class I: Patients with cardiac disease but without resulting limitations of physical activity.
Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.
Class III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain.
Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased.
Measured: 12 months
Clinical Measures of Benefit-Quality of Life (QOL) as Measured by Short Form (SF) 36
Standardized quality of life surveys allow physicians to evaluate the effectiveness of different treatment methods and the physical and psychological benefits a patient is likely to receive from a particular treatment.In the EVEREST II HRR,the patients were asked to complete the SF-36 QOL survey at baseline, 30 days and 12 months. The physical \& mental function were assessed by the Physical Component Summary (PCS) score \& Mental Component Summary (MCS) score. The PCS \& MCS norms for 65-75 year olds are 44 and 52 respectively; and 31 \& 46 for congestive heart failure (CHF) patients respectively. Each scale from the SF-36 is an algebraic sum of responses for all items in that scale.For ease of analysis each scale is then transformed to a 0-100 scale using a formula that converts the lowest \& highest possible scores to 0 \& 100 respectively.The scoring of the SF-36 indicates that 0% in a domain represents the poorest possible QoL \& 100% indicates full QoL.
Measured: 12 months
Left Ventricular End Diastolic Volume (LVEDV)
Left Ventricular End Diastolic Volume (LVEDV) as determined by the core echocardiography laboratory from a transthoracic echocardiogram (TTE).
Measured: 12 months
Left Ventricular End Systolic Volume (LVESV)
Left Ventricular End Systolic Volume (LVESV) as determined by the core echocardiography laboratory from a transthoracic echocardiogram (TTE).
Measured: 12 months
Left Ventricular (LV) Function - Internal Dimension
Left Ventricular Internal Dimension in diastole (LVIDd) and Left Ventricular Internal Dimension in systole (LVIDs) as determined by the core echocardiography laboratory from a transthoracic echocardiogram (TTE).
Measured: 12 months
Number of Patients With CHF Having Hospitalization During Discharge Through 12 Months
Number of patients with incidence of re-hospitalizations for CHF in the 12-months after the MitraClip implant procedure.
Measured: 12 months
Number of CHF Events Leading to Hospitalizations During Discharge Through 12 Months
Incidence of re-hospitalizations for CHF in the 12-months after the MitraClip implant procedure.
Measured: 12 months
Left Ventricular End Diastolic Volume (LVEDV)
Left Ventricular End Diastolic Volume (LVEDV) as determined by the core echocardiography laboratory from a transthoracic echocardiogram (TTE).
Measured: Discharge or 30 days
Left Ventricular End Systolic Volume (LVESV)
Left Ventricular End Systolic Volume (LVESV) as determined by the core echocardiography laboratory from a transthoracic echocardiogram (TTE).
Measured: Discharge or 30 days
Left Ventricular (LV) Function - Internal Dimension
Left Ventricular Internal Dimension in diastole (LVIDd) and Left Ventricular Internal Dimension in systole (LVIDs) as determined by the core echocardiography laboratory from a transthoracic echocardiogram (TTE).
Measured: Discharge or 30 days

Secondary outcomes (138)

Number of Participants Experiencing Major Adverse Events (MAE)
Combined clinical endpoint of death, myocardial infarction, reoperation for failed surgical repair or replacement, nonelective cardiovascular surgery for adverse events, stroke, renal failure, deep wound infection, ventilation for greater than 48 hours, GI complication requiring surgery, new onset of permanent atrial fibrillation, septicemia, and transfusion of 2 or more units of blood.
Measured: 30 days
Number of Participants Experiencing Major Adverse Events
Combined clinical endpoint of death, myocardial infarction, reoperation for failed surgical repair or replacement, nonelective cardiovascular surgery for adverse events, stroke, renal failure, deep wound infection, ventilation for greater than 48 hours, GI complication requiring surgery, new onset of permanent atrial fibrillation, septicemia, and transfusion of 2 or more units of blood.
Measured: 12 months
Procedural Freedom From In-hospital MAE
Percutaneous Clip procedure or surgery with no occurrence of in-hospital MAE.
Measured: 30 Days
Number of Participants Over 75 Years of Age With MAE
Combined clinical endpoint of death, myocardial infarction, reoperation for failed surgical repair or replacement, nonelective cardiovascular surgery for adverse events, stroke, renal failure, deep wound infection, ventilation for greater than 48 hours, GI complication requiring surgery, new onset of permanent atrial fibrillation, septicemia, and transfusion of 2 or more units of blood.
Measured: 30 days
Number of Participants Over 75 Years of Age With MAE
Combined clinical endpoint of death, myocardial infarction, reoperation for failed surgical repair or replacement, nonelective cardiovascular surgery for adverse events, stroke, renal failure, deep wound infection, ventilation for greater than 48 hours, GI complication requiring surgery, new onset of permanent atrial fibrillation, septicemia, and transfusion of 2 or more units of blood.
Measured: 12 months
Number of Participants Experiencing Major Vascular Complications
Defined as the occurrence of any of the following resulting from the index procedure:
- Hematoma at access site >6 cm;
- Retroperitoneal hematoma;
- Arterial-venous fistula;
- Symptomatic peripheral ischemia/ nerve injury with clinical signs or symptoms lasting >24 hours;
- Vascular surgical repair at catheter access sites;
- Pulmonary embolism;
- Ipsilateral deep vein thrombus; or
- Access site-related infection requiring intravenous antibiotics and/or extended hospitalization.
Measured: 30 days
Number of Participants Experiencing Major Vascular Complications
Defined as the occurrence of any of the following resulting from the index procedure:
- Hematoma at access site >6 cm;
- Retroperitoneal hematoma;
- Arterial-venous fistula;
- Symptomatic peripheral ischemia/ nerve injury with clinical signs or symptoms lasting >24 hours;
- Vascular surgical repair at catheter access sites;
- Pulmonary embolism;
- Ipsilateral deep vein thrombus; or
- Access site-related infection requiring intravenous antibiotics and/or extended hospitalization.
Measured: 12 months
Number of Participants With Major Bleeding Complications
Defined as procedure related bleeding that requires a transfusion of ≥2 units of blood and/or surgical intervention.
Measured: 30 days
Number of Participants With Major Bleeding Complications
Defined as procedure related bleeding that requires a transfusion of ≥2 units of blood and/or surgical intervention.
Measured: 12 months
Number of Participants With Non-cerebral Thromboembolism
Defined as any mural thrombus or thromboembolism in the vasculature (excluding central nervous system events) confirmed by standard clinical and laboratory testing and which requires intervention.
Measured: 30 days
Number of Participants With Non-cerebral Thromboembolism
Defined as any mural thrombus or thromboembolism in the vasculature (excluding central nervous system events) confirmed by standard clinical and laboratory testing and which requires intervention.
Measured: 12 months
Number of Participants With Thrombosis
Evidence of formation of an independently moving thrombus on any part of the Clip or any commercially available implant used during surgery by echocardiography or fluoroscopy. If Clip is explanted or an autopsy is performed this diagnosis should be confirmed.
Measured: 30 days
Number of Participants With Thrombosis
Evidence of formation of an independently moving thrombus on any part of the Clip or any commercially available implant used during surgery by echocardiography or fluoroscopy. If Clip is explanted or an autopsy is performed this diagnosis should be confirmed.
Measured: 12 months
Number of Participants With Hemolysis
Defined as new onset of anemia associated with laboratory evidence of red cell destruction. Diagnosed when plasma free hemoglobin is greater than 40 mg/dL on two measures within 24 hours or on one measure if intervention is initiated based on other clinical symptoms
Measured: 30 days
Number of Participants With Hemolysis
Defined as new onset of anemia associated with laboratory evidence of red cell destruction. Diagnosed when plasma free hemoglobin is greater than 40 mg/dL on two measures within 24 hours or on one measure if intervention is initiated based on other clinical symptoms.
Measured: 12 months
Number of Participants With Dysrhythmias
Includes all new onset atrial fibrillation and heart block requiring placement of a permanent pacemaker.
Measured: 30 days
Number of Participants With Dysrhythmias
Includes all new onset atrial fibrillation and heart block requiring placement of a permanent pacemaker.
Measured: 12 months
Number of Participants With Endocarditis
Using Duke Criteria, endocarditis can be confirmed by:
Pathological criteria: Endocarditis is confirmed if microorganisms are identified by culture or histology in a vegetation, embolized vegetation, or an intracardiac abscess; or if pathological lesions are observed \& histologically confirmed showing active endocarditis.
Clinical criteria: Endocarditis is confirmed by the presence of 2 major criteria, 1 major plus 3 minor criteria, or 5 minor criteria. Major criteria include persistently +ve blood cultures with the presence of typical organisms for endocarditis; persistent bacteremia; evidence of endocardial involvement with positive echocardiogram with signs of oscillating vegetation, abscesses, valve perforation, new partial dehiscence of prosthetic valve or new valvular regurgitation. Minor criteria include predisposing heart condition, fever, vascular phenomena, immunologic phenomena, \& positive blood culture or echocardiogram not meeting major criteria.
Measured: 30 days
Number of Participants With Endocarditis
Using Duke Criteria, endocarditis can be confirmed by:
Pathological criteria: Endocarditis is confirmed if microorganisms are identified by culture or histology in a vegetation, embolized vegetation, or an intracardiac abscess; or if pathological lesions are observed \& histologically confirmed showing active endocarditis.
Clinical criteria: Endocarditis is confirmed by the presence of 2 major criteria, 1 major plus 3 minor criteria, or 5 minor criteria.
Major criteria include persistently +ve blood cultures with the presence of typical organisms for endocarditis; persistent bacteremia; evidence of endocardial involvement with positive echocardiogram with signs of oscillating vegetation, abscesses, valve perforation, new partial dehiscence of prosthetic valve or new valvular regurgitation.
Minor criteria include predisposing heart condition, fever, vascular phenomena, immunologic phenomena, \& positive blood culture or echocardiogram not meeting major criteria.
Measured: 12 months
Number of Participants With Atrial Septal Defect (ASD)
Occurrence of clinically significant ASD as a result of the procedure requiring intervention.
Measured: 30 days
Number of Participants With Atrial Septal Defect (ASD)
Occurrence of clinically significant ASD as a result of the procedure requiring intervention.
Measured: 12 months
Number of Participants With Mitral Valve Stenosis
Mitral stenosis associated with a total mitral valve orifice area less than 1.5 cm2.
Measured: 30 days
Number of Participants With Mitral Valve Stenosis
Mitral stenosis associated with a total mitral valve orifice area less than 1.5 cm2.
Measured: 12 months
Number of Participants With Mitral Valve Stenosis
Mitral stenosis associated with a total mitral valve orifice area less than 1.5 cm2.
Measured: 24 months
Number of Participants With Mitral Valve Stenosis
Mitral stenosis associated with a total mitral valve orifice area less than 1.5 cm2.
Measured: 36 months
Number of Participants With Mitral Valve Stenosis
Mitral stenosis associated with a total mitral valve orifice area less than 1.5 cm2.
Measured: 48 months
Mitral Valve Area: By Planimetry
Mitral valve area as measured by core lab echocardiography.
Measured: 30 days
Mitral Valve Area: By Planimetry
Mitral valve area as measured by core lab echocardiography.
Measured: 12 months
Mitral Valve Area: By Planimetry
Mitral valve area as measured by core lab echocardiography.
Measured: 24 months
Mitral Valve Area: By Planimetry
Mitral valve area as measured by core lab echocardiography.
Measured: 36 months
Mitral Valve Area: By Planimetry
Mitral valve area as measured by core lab echocardiography.
Measured: 48 months
Mitral Valve Area: By Planimetry
Mitral valve area as measured by core lab echocardiography.
Measured: 60 months
Mitral Valve Area: By Pressure Half-time
Mitral valve area as measured by core lab echocardiography.
Measured: 30 days
Mitral Valve Area: By Pressure Half-time
Mitral valve area as measured by core lab echocardiography.
Measured: 12 months
Mitral Valve Area: By Pressure Half-time
Mitral valve area as measured by core lab echocardiography.
Measured: 24 months
Mitral Valve Area: By Pressure Half-time
Mitral valve area as measured by core lab echocardiography.
Measured: 36 months
Mitral Valve Area: By Pressure Half-time
Mitral valve area as measured by core lab echocardiography.
Measured: 48 months
Mitral Valve Area: By Pressure Half-time
Mitral valve area as measured by core lab echocardiography.
Measured: 60 months
Mitral Valve Area Index : By Planimetry
Mitral valve area as measured by core lab echocardiography by planimetry and indexed to body surface area [MVA Index = MVA (cm^2)/BSA (m^2)].
Measured: 30 days
Mitral Valve Area Index : By Planimetry
Mitral valve area as measured by core lab echocardiography by planimetry and indexed to body surface area [MVA Index = MVA (cm^2)/BSA (m^2)].
Measured: 12 months
Mitral Valve Area Index : By Planimetry
Mitral valve area as measured by core lab echocardiography by planimetry and indexed to body surface area [MVA Index = MVA (cm^2)/BSA (m^2)].
Measured: 24 months
Mitral Valve Area Index : By Planimetry
Mitral valve area as measured by core lab echocardiography by planimetry and indexed to body surface area [MVA Index = MVA (cm^2)/BSA (m^2)].
Measured: 36 months
Mitral Valve Area Index : By Planimetry
Mitral valve area as measured by core lab echocardiography by planimetry and indexed to body surface area [MVA Index = MVA (cm^2)/BSA (m^2)].
Measured: 48 months
Mitral Valve Area Index : By Planimetry
Mitral valve area as measured by core lab echocardiography by planimetry and indexed to body surface area [MVA Index = MVA (cm^2)/BSA (m^2)].
Measured: 60 months
Mitral Valve Area (MVA) Index: by Pressure-Half Time Formula
Mitral valve area as measured by core lab echocardiography using the pressure half-time formula and indexed to Body surface area (BSA).
[MVA Index = MVA (cm^2)/BSA (m^2)]
Measured: 30 days
Mitral Valve Area Index : By Pressure Half-time Formula
Mitral valve area as measured by core lab echocardiography using the pressure half-time formula and indexed to body surface area [MVA Index = MVA (cm^2)/BSA (m^2)].
Measured: 12 months
Mitral Valve Area Index : By Pressure Half-time Formula
Mitral valve area as measured by core lab echocardiography using the pressure half-time formula and indexed to body surface area [MVA Index = MVA (cm^2)/BSA (m^2)].
Measured: 24 months
Mitral Valve Area Index : By Pressure Half-time Formula
Mitral valve area as measured by core lab echocardiography using the pressure half-time formula and indexed to body surface area [MVA Index = MVA (cm^2)/BSA (m^2)].
Measured: 36 months
Mitral Valve Area Index : By Pressure Half-time Formula
Mitral valve area as measured by core lab echocardiography using the pressure half-time formula and indexed to body surface area [MVA Index = MVA (cm^2)/BSA (m^2)].
Measured: 48 months
Mitral Valve Area Index : By Pressure Half-time Formula
Mitral valve area as measured by core lab echocardiography using the pressure half-time formula and indexed to body surface area [MVA Index = MVA (cm^2)/BSA (m^2)].
Measured: 60 months
Transvalvular Mitral Valve Gradient
Defined as the mean pressure gradients across the mitral valve as measured by echocardiography.
Measured: 30 days
Transvalvular Mitral Valve Gradient
Defined as the mean pressure gradients across the mitral valve as measured by echocardiography.
Measured: 12 months
Transvalvular Mitral Valve Gradient
Defined as the mean pressure gradients across the mitral valve as measured by echocardiography.
Measured: 24 months
Transvalvular Mitral Valve Gradient
Defined as the mean pressure gradients across the mitral valve as measured by echocardiography.
Measured: 36 months
Transvalvular Mitral Valve Gradient
Defined as the mean pressure gradients across the mitral valve as measured by echocardiography.
Measured: 48 months
Transvalvular Mitral Valve Gradient
Defined as the mean pressure gradients across the mitral valve as measured by echocardiography.
Measured: 60 months
Mitral Valve Index
Mitral valve area as measured by core lab echocardiography and indexed to body surface area [MVA Index = MVA (cm^2)/BSA (m^2)]
Measured: 30 days
Mitral Valve Index
Mitral valve area as measured by core lab echocardiography and indexed to body surface area [MVA Index = MVA (cm^2)/BSA (m^2)]
Measured: 12 months
Number of Participants With New Coumadin Use
New onset use of Coumadin or warfarin to treat a potential thrombus on a defibrillator lead.
Measured: 30 days
Number of Participants With New Coumadin Use
New onset use of Coumadin or warfarin to treat a potential thrombus on a defibrillator lead.
Measured: 6 months
Number of Participants With New Coumadin Use
New onset use of Coumadin or warfarin to treat a potential thrombus on a defibrillator lead.
Measured: 12 months
Number of Participants Discharged to a Nursing Home or Skilled Nursing Facility or Hospital
Discharge to a nursing home or skilled nursing facility following discharge from the hospital after definitive treatment.
Measured: 30 Days
Post-procedure Length of Hospital Stay
Defined as the number of days from the end of the procedure until the patient is discharged from the hospital. This does not include time in a nursing or skilled care facility.
Measured: Length of Hospital Stay, assessed at 30 days
Post-procedure Intensive Care Unit (ICU)/ Critical Care Unit (CCU) Time
Number of hours patients are in an intensive care unit or step down unit before discharge or moving to a standard care unit.
Measured: Length of ICU/CCU stay, assessed at 30 Days
Number of Participants With Successful Clip Implant
Rate of successful delivery and deployment of Clip implants with echocardiographic evidence of leaflet approximation and retrieval of the investigational delivery catheter.
Measured: 30 Days
Number of Participants With High Risk Procedural Success
Successful implantation of the Clip (s) with resulting MR severity of 2+ of less at discharge or a 1 grade MR reduction at discharge accompanied by a 1 level reduction in NYHA.
Measured: 30 days
Number of Participants With MR Severity
MR Severity: Site-assessed mitral regurgitation severity using echocardiography. MR severity is graded on a scale of 0+ to 4+ where 0+ means absence of mitral regurgitation, 1+ is mild, 1+ to 2+ is mild-to-moderate, 2+ to 3+ is moderate to moderate-to-Severe, 3+ is moderate-to-severe, 3+ to 4+ is moderate-to-severe to severe, 4+ is severe.
Measured: Discharge or 30 days
Number of Participants With MR Severity
MR Severity: Site-assessed mitral regurgitation severity using echocardiography. MR severity is graded on a scale of 0+ to 4+ where 0+ means absence of mitral regurgitation, 1+ is mild, 1+ to 2+ is mild-to-moderate, 2+ to 3+ is moderate to moderate-to-Severe, 3+ is moderate-to-severe, 3+ to 4+ is moderate-to-severe to severe, 4+ is severe.
Measured: 12 months
Number of Participants With MR Severity
MR Severity: Site-assessed mitral regurgitation severity using echocardiography. MR severity is graded on a scale of 0+ to 4+ where 0+ means absence of mitral regurgitation, 1+ is mild, 1+ to 2+ is mild-to-moderate, 2+ to 3+ is moderate to moderate-to-Severe, 3+ is moderate-to-severe, 3+ to 4+ is moderate-to-severe to severe, 4+ is severe.
Measured: 24 months
Number of Participants With MR Severity
MR Severity: Site-assessed mitral regurgitation severity using echocardiography. MR severity is graded on a scale of 0+ to 4+ where 0+ means absence of mitral regurgitation, 1+ is mild, 1+ to 2+ is mild-to-moderate, 2+ to 3+ is moderate to moderate-to-Severe, 3+ is moderate-to-severe, 3+ to 4+ is moderate-to-severe to severe, 4+ is severe.
Measured: 36 months
Number of Participants With MR Severity
MR Severity: Site-assessed mitral regurgitation severity using echocardiography. MR severity is graded on a scale of 0+ to 4+ where 0+ means absence of mitral regurgitation, 1+ is mild, 1+ to 2+ is mild-to-moderate, 2+ to 3+ is moderate to moderate-to-Severe, 3+ is moderate-to-severe, 3+ to 4+ is moderate-to-severe to severe, 4+ is severe.
Measured: 48 months
Number of Participants With MR Severity
MR Severity: Site-assessed mitral regurgitation severity using echocardiography. MR severity is graded on a scale of 0+ to 4+ where 0+ means absence of mitral regurgitation, 1+ is mild, 1+ to 2+ is mild-to-moderate, 2+ to 3+ is moderate to moderate-to-Severe, 3+ is moderate-to-severe, 3+ to 4+ is moderate-to-severe to severe, 4+ is severe.
Measured: 60 months
Number of Participants With Treatment Durability
Defined as the proportion of Acute Procedural Success patients with MR severity grade of 2+ or less that have not required surgery for valve dysfunction.
Measured: 12 months
Number of Participants With Treatment Durability
Defined as the proportion of Acute Procedural Success patients with MR severity grade of 2+ or less that have not required surgery for valve dysfunction.
Measured: 24 months
Number of Participants With Clinical Durability
Proportion of patients who have an acute reduction in MR severity of at least one grade (as measured by the discharge echocardiogram) that have not required surgery for valve dysfunction and meet either of the following: 1) MR severity grade of 2+ or less or 2) a one grade reduction in MR severity compared to baseline accompanied by at least a one level reduction in NYHA.
Measured: 12 months
Number of Participants With Clinical Durability
Proportion of patients who have an acute reduction in MR severity of at least one grade (as measured by the discharge echocardiogram) that have not required surgery for valve dysfunction and meet either of the following: 1) MR severity grade of 2+ or less or 2) a one grade reduction in MR severity compared to baseline accompanied by at least a one level reduction in NYHA.
Measured: 24 months
Number of Participants With Composite Functional and Structural Measures - Clinical Measures of Benefit-New York Heart Association (NYHA) Class
Class I: Patients with cardiac disease but without resulting limitations of physical activity.
Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.
Class III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain.
Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased.
Measured: 24 months
Number of Participants With Composite Functional and Structural Measures - Clinical Measures of Benefit-New York Heart Association (NYHA) Class
Class I: Patients with cardiac disease but without resulting limitations of physical activity.
Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.
Class III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain.
Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased.
Measured: 36 months
Number of Participants With Composite Functional and Structural Measures - Clinical Measures of Benefit-New York Heart Association (NYHA) Class
Class I: Patients with cardiac disease but without resulting limitations of physical activity.
Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.
Class III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain.
Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased.
Measured: 48 months
Number of Participants With New York Heart Association (NYHA) Class
Class I: Patients with cardiac disease but without resulting limitations of physical activity.
Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.
Class III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain.
Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased.
Measured: 60 months
Left Ventricular End-diastolic Volume (LVEDV).
Left Ventricular End Diastolic Volume (LVEDV) as determined by the core echocardiography laboratory from a transthoracic echocardiogram (TTE).
Measured: 24 months
Left Ventricular End-diastolic Volume (LVEDV).
Left Ventricular End Diastolic Volume (LVEDV) as determined by the core echocardiography laboratory from a transthoracic echocardiogram (TTE).
Measured: 36 months
Left Ventricular End-diastolic Volume (LVEDV).
Left Ventricular End Diastolic Volume (LVEDV) as determined by the core echocardiography laboratory from a transthoracic echocardiogram (TTE).
Measured: 48 months
Left Ventricular End-diastolic Volume (LVEDV).
Left Ventricular End Diastolic Volume (LVEDV) as determined by the core echocardiography laboratory from a transthoracic echocardiogram (TTE).
Measured: 60 months
Left Ventricular End-systolic Volume (LVESV).
Left Ventricular End Systolic Volume (LVESV) as determined by the core echocardiography laboratory from a transthoracic echocardiogram (TTE).
Measured: 24 months
Left Ventricular End-systolic Volume (LVESV).
Left Ventricular End Systolic Volume (LVESV) as determined by the core echocardiography laboratory from a transthoracic echocardiogram (TTE).
Measured: 36 months
Left Ventricular End-systolic Volume (LVESV).
Left Ventricular End Systolic Volume (LVESV) as determined by the core echocardiography laboratory from a transthoracic echocardiogram (TTE).
Measured: 48 months
Left Ventricular End-systolic Volume (LVESV).
Left Ventricular End Systolic Volume (LVESV) as determined by the core echocardiography laboratory from a transthoracic echocardiogram (TTE).
Measured: 60 months
Left Ventricular Measurement: Left Ventricular Internal Dimension Diastole (LVIDd), Left Ventricular Internal Dimension Systole (LVIDs)
Left Ventricular Internal Dimension in diastole (LVIDd) and Left Ventricular Internal Dimension in systole (LVIDs) as determined by the core echocardiography laboratory from a transthoracic echocardiogram (TTE).
Measured: 24 months
Left Ventricular Measurement: Left Ventricular Internal Dimension Diastole (LVIDd), Left Ventricular Internal Dimension Systole (LVIDs)
Left Ventricular Internal Dimension in diastole (LVIDd) and Left Ventricular Internal Dimension in systole (LVIDs) as determined by the core echocardiography laboratory from a transthoracic echocardiogram (TTE).
Measured: 36 months
Left Ventricular Measurement: Left Ventricular Internal Dimension Diastole (LVIDd), Left Ventricular Internal Dimension Systole (LVIDs)
Left Ventricular Internal Dimension in diastole (LVIDd) and Left Ventricular Internal Dimension in systole (LVIDs) as determined by the core echocardiography laboratory from a transthoracic echocardiogram (TTE).
Measured: 48 months
Left Ventricular Measurement: Left Ventricular Internal Dimension Diastole (LVIDd), Left Ventricular Internal Dimension Systole (LVIDs)
Left Ventricular Internal Dimension in diastole (LVIDd) and Left Ventricular Internal Dimension in systole (LVIDs) as determined by the core echocardiography laboratory from a transthoracic echocardiogram (TTE).
Measured: 60 months
Number of Days Re-hospitalized for CHF
Defined as the number of days hospitalized for CHF in the 12-months prior to the Clip implant procedure date compared to the number of days re-hospitalized for CHF in the 12-months after Clip implant.
Measured: 12 months
Number of Hospital Re-Admissions for Congestive Heart Failure (CHF)
Defined as the number of hospital admissions (i.e. events) for which the primary diagnosis for hospitalization is congestive heart failure, in the 12-months post-discharge following the MitraClip procedure.
Measured: 12 months
Regurgitant Volume
Regurgitant volume as measured by the core echocardiographic laboratory at follow-up.
Measured: 30 days
Regurgitant Volume
Regurgitant volume as measured by the core echocardiographic laboratory at follow-up.
Measured: 12 months
Regurgitant Volume
Regurgitant volume as measured by the core echocardiographic laboratory at follow-up.
Measured: 24 months
Regurgitant Fraction (RF)
RF is defined as the percentage of the left ventricular (LV) stroke volume that regurgitates into the left atrium.
Measured: 30 days
Regurgitant Fraction
RF is defined as the percentage of the left ventricular (LV) stroke volume that regurgitates into the left atrium.
Measured: 12 months
Regurgitant Fraction
RF is defined as the percentage of the left ventricular (LV) stroke volume that regurgitates into the left atrium.
Measured: 24 months
Cardiac Output (CO)
CO is defined as the volume of blood pumped by the left ventricle per unit time (L/min).
Measured: 30 Days
Cardiac Output
CO is defined as the volume of blood pumped by the left ventricle per unit time (L/min)
Measured: 12 months
Cardiac Output
CO is defined as the volume of blood pumped by the left ventricle per unit time (L/min)
Measured: 24 months
Cardiac Index
Cardiac index (cardiac output divided by body surface area) as measured by core lab echocardiography.
Measured: 30 Days
Cardiac Index
Cardiac index (cardiac output divided by body surface area) as measured by core lab echocardiography.
Measured: 12 months
Cardiac Index
Cardiac index (cardiac output divided by body surface area) as measured by core lab echocardiography.
Measured: 24 months
Left Ventricular Ejection Fraction (LVEF)
Left Ventricular Ejection Fraction (LVEF) as determined by the core echocardiography laboratory.
Measured: Discharge or 30 days
Left Ventricular Ejection Fraction (LVEF)
Left Ventricular Ejection Fraction (LVEF) as determined by the core echocardiography laboratory.
Measured: 12 months
Left Ventricular Ejection Fraction (LVEF)
Left Ventricular Ejection Fraction (LVEF) as determined by the core echocardiography laboratory.
Measured: 24 months
Left Ventricular Ejection Fraction (LVEF)
Left Ventricular Ejection Fraction (LVEF) as determined by the core echocardiography laboratory.
Measured: 36 months
Left Ventricular Ejection Fraction (LVEF)
Left Ventricular Ejection Fraction (LVEF) as determined by the core echocardiography laboratory.
Measured: 48 months
Left Ventricular Ejection Fraction (LVEF)
Left Ventricular Ejection Fraction (LVEF) as determined by the core echocardiography laboratory.
Measured: 60 months
Percentage of Participants With Freedom From Mitral Valve Surgery
Percentage of patients who did not undergo surgical mitral valve repair or replacement after the index MitraClip procedure
Measured: Baseline
Percentage of Participants With Freedom From Mitral Valve Surgery
Percentage of patients who did not undergo surgical mitral valve repair or replacement after the index MitraClip procedure
Measured: 12 months
Percentage of Participants With Freedom From Mitral Valve Surgery
Percentage of patients who did not undergo surgical mitral valve repair or replacement after the index MitraClip procedure
Measured: 24 months
Percentage of Participants With Freedom From Mitral Valve Surgery
Percentage of patients who did not undergo surgical mitral valve repair or replacement after the index MitraClip procedure
Measured: 36 months
Percentage of Participants With Freedom From Mitral Valve Surgery
Percentage of patients who did not undergo surgical mitral valve repair or replacement after the index MitraClip procedure
Measured: 48 months
Percentage of Participants With Freedom From Mitral Valve Surgery
Percentage of patients who did not undergo surgical mitral valve repair or replacement after the index MitraClip procedure
Measured: 60 months
Number of Participants With Mitral Valve Repair Success
Mitral Valve Repair Success defined as freedom from mitral valve replacement surgery for valve dysfunction, death, re-operation and MR > 2+ at 12 months.
Measured: 12 months
Number of Participants With Mitral Valve Repair Success
Freedom from mitral valve replacement surgery for Valve Dysfunction, death, re-operation, and MR > 2+.
Measured: 24 months
Composite Functional and Structural Measures - Percentage of Participants With Freedom From Death
Defined as all causes of death for the primary safety Major Adverse Event (MAE) Endpoint. Death is further divided into 2 categories:
1. Cardiac death is defined as death due to any of the following:
2. Acute myocardial infarction.
3. Cardiac perforation/pericardial tamponade.
4. Arrhythmia or conduction abnormality.
5. Stroke within 30 days of the procedure or stroke suspected of being related to the procedure.
6. Death due to any complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.
7. Any death for which a cardiac cause cannot be excluded.
8. Non-cardiac death is defined as a death not due to cardiac causes (as defined above).
Measured: 24 months
Percentage of Participants With Composite Functional and Structural Measures - Freedom From Death and MR >2+
Kaplan-Meier estimated proportion of patients who are alive and have a mitral regurgitation severity grade of 2+ or less.
Measured: 24 months
Number of Participants With Device Embolization or Single Leaflet Device Attachment
Device embolization is defined as bilateral Clip detachment resulting in Clip embolization. Reasons for Clip embolization include leaflet tearing, Clip unlocking, Clip fracture or inadequate Clip placement (i.e., malposition). Not included are any fractures or other failures of the Clip that do not result in Clip detachment from both leaflets.
A single leaflet device attachment (SLDA) is defined as attachment of one mitral valve leaflet to the MitraClip device.
Measured: 0 to 12 months
Number of Participants With Device Embolization or Single Leaflet Device Attachment
Device embolization is defined as bilateral Clip detachment resulting in Clip embolization. Reasons for Clip embolization include leaflet tearing, Clip unlocking, Clip fracture or inadequate Clip placement (i.e., malposition). Not included are any fractures or other failures of the Clip that do not result in Clip detachment from both leaflets.
A single leaflet device attachment (SLDA) is defined as attachment of one mitral valve leaflet to the MitraClip device.
Measured: 24 months
Number of Participants With Device Embolization or Single Leaflet Device Attachment
Device embolization is defined as bilateral Clip detachment resulting in Clip embolization. Reasons for Clip embolization include leaflet tearing, Clip unlocking, Clip fracture or inadequate Clip placement (i.e., malposition). Not included are any fractures or other failures of the Clip that do not result in Clip detachment from both leaflets.
A single leaflet device attachment (SLDA) is defined as attachment of one mitral valve leaflet to the MitraClip device.
Measured: 48 months
Number of Participants With Device Embolization or Single Leaflet Device Attachment
Device embolization is defined as bilateral Clip detachment resulting in Clip embolization. Reasons for Clip embolization include leaflet tearing, Clip unlocking, Clip fracture or inadequate Clip placement (i.e., malposition). Not included are any fractures or other failures of the Clip that do not result in Clip detachment from both leaflets.
A single leaflet device attachment (SLDA) is defined as attachment of one mitral valve leaflet to the MitraClip device.
Measured: 36 months
Number of Participants With Device Embolization or Single Leaflet Device Attachment
Device embolization is defined as bilateral Clip detachment resulting in Clip embolization. Reasons for Clip embolization include leaflet tearing, Clip unlocking, Clip fracture or inadequate Clip placement (i.e., malposition). Not included are any fractures or other failures of the Clip that do not result in Clip detachment from both leaflets.
A single leaflet device attachment (SLDA) is defined as attachment of one mitral valve leaflet to the MitraClip device.
Measured: 60 months
Number of Participants With Mitral Valve Surgery Post-MitraClip Procedure
Number of patients who underwent surgical mitral valve repair or replacement after the index MitraClip procedure.
Measured: 60 months
Number of Participants With Second MitraClip Device Implanted
It is a summary of re-interventions to place an additional MitraClip Device.
Measured: 0 to 5 years
Percentage of Participants With Freedom From All-Cause Mortality and Mitral Valve Surgery
Kaplan-Meier estimate of the percentage of patients who are alive and did not undergo surgical mitral valve repair or replacement after the index MitraClip procedure
Measured: 12 months
Percentage of Participants With Freedom From All-Cause Mortality and Mitral Valve Surgery
Kaplan-Meier estimate of the percentage of patients who are alive and did not undergo surgical mitral valve repair or replacement after the index MitraClip procedure
Measured: 24 months
Percentage of Participants With Freedom From All-Cause Mortality and Mitral Valve Surgery
Kaplan-Meier estimate of the percentage of patients who are alive and did not undergo surgical mitral valve repair or replacement after the index MitraClip procedure
Measured: 36 months
Percentage of Participants With Freedom From All-Cause Mortality and Mitral Valve Surgery
Kaplan-Meier estimate of the percentage of patients who are alive and did not undergo surgical mitral valve repair or replacement after the index MitraClip procedure
Measured: 48 months
Percentage of Participants With Freedom From All-Cause Mortality and Mitral Valve Surgery
Kaplan-Meier estimate of the percentage of patients who are alive and did not undergo surgical mitral valve repair or replacement after the index MitraClip procedure
Measured: 60 months
Number of Participants With Mitral Valve Replacement
Defined as how often patients receiving surgery required replacement of the mitral valve.
Measured: 12 months
Number of Participants With Mitral Valve Replacement
Defined as how often patients receiving surgery required replacement of the mitral valve.
Measured: 24 months
Number of Participants With Mitral Valve Replacement
Defined as how often patients receiving surgery required replacement of the mitral valve.
Measured: 36 months
Number of Participants With Mitral Valve Replacement
Defined as how often patients receiving surgery required replacement of the mitral valve.
Measured: 48 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2007Feb 2013

First posted12 Sep 2013 (estimated)
Study startFeb 2007
Primary completionMar 2008
Study completionFeb 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Mitral Valve InsufficiencyStudies of the same condition, open and under way.
More trials run by Abbott Medical DevicesThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 78 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01940120
Sponsor's protocol ID: 0401A
Acronym: HRR
Status last verified: Nov 2018
First submitted: 3 Sep 2013
Last updated: 7 Nov 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Ailawadi G, Lim DS, Mack MJ, Trento A, Kar S, Grayburn PA, Glower DD, Wang A, Foster E, Qasim A, Weissman NJ, Ellis J, Crosson L, Fan F, Kron IL, Pearson PJ, Feldman T; EVEREST II Investigators. One-Year Outcomes After MitraClip for Functional Mitral Regurgitation. Circulation. 2019 Jan 2;139(1):37-47. doi: 10.1161/CIRCULATIONAHA.117.031733.
PubMed 30586701
Kar S, Feldman T, Qasim A, Trento A, Kapadia S, Pedersen W, Lim DS, Kipperman R, Smalling RW, Bajwa T, Hermann HC, Hermiller JB, Lasala JM, Reisman M, Glower D, Mauri L, Whitlow P; EVEREST II Investigators. Five-year outcomes of transcatheter reduction of significant mitral regurgitation in high-surgical-risk patients. Heart. 2019 Nov;105(21):1622-1628. doi: 10.1136/heartjnl-2017-312605. Epub 2018 Aug 4.
PubMed 30077993
Wang A, Sangli C, Lim S, Ailawadi G, Kar S, Herrmann HC, Grayburn P, Foster E, Weissman NJ, Glower D, Feldman T. Evaluation of renal function before and after percutaneous mitral valve repair. Circ Cardiovasc Interv. 2015 Jan;8(1):e001349. doi: 10.1161/CIRCINTERVENTIONS.113.001349.
PubMed 25593120

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
PRECISE-AFMR I: Transcatheter Mitral Valve Edge-to-Edge Repair for Atrial Functional Mitral Regurgitation in Patients at High Surgical Risk
Atrial Functional, Mitral Regurgitation (MR)
Active, not recruiting
A Feasibility Study of the Millipede Transcatheter Annuloplasty Ring System in Patients With Functional Mitral Regurgitation
Mitral Regurgitation Functional, Mitral Valve Disease
Active, not recruitingObservational study
Expanded Studies on the SCAPIS Stockholm Reexamination Cohort
Coronary Artery Disease, Arterial Stiffness, Blood Pressure
Not yet recruiting
The PALMETTO Study
Mitral Regurgitation
RecruitingObservational study
Continuous Dual Aspiration Technique With Zoom System for Stroke
Ischemic Stroke, Acute Stroke

All Mitral Valve Insufficiency trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Study of the Evalve® Cardiovascular Valve Repair (MitraClip®) System Endovascular Valve Edge-to-Edge REpair STudy (EVEREST II) EVEREST II High Risk Registry
ClinicalTrials.gov ID: NCT01940120
Acronym / sponsor ID: HRR / 0401A
Conditions: Mitral Valve Insufficiency, Mitral Valve Regurgitation, Mitral Valve Incompetence, Mitral Regurgitation, Mitral Insufficiency
Keywords: Mitral Valve Insufficiency, Mitral Valve Regurgitation, Mitral Valve Incompetence, Mitral Regurgitation, Mitral Insufficiency, Mitral Valve, MR, Mitral Valve Prolapse
Study type: Interventional
Recruitment status: Completed
Enrolment: 78 participants (actual)
Lead sponsor: Abbott Medical DevicesIndustry (pharma, biotech, devices)
Study start: Feb 2007
Primary completion: Mar 2008 (actual)
Study completion: Feb 2013 (actual)
First posted: 12 Sep 2013 (estimated)
Results: Posted 16 Jan 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Prospective, multi-center, single arm registry. Clinical follow-up at discharge, 30 days, 6, 12, 18 and 24, months, and 3, 4 and 5 years.

Detailed description

The EVEREST II HRR is a single-arm prospective, multicenter clinical trial enrolling high surgical risk patients of the EVEREST II study (NCT00209274).

Porcelain aorta or mobile ascending aortic atheroma
Post-radiation mediastinum
Previous mediastinitis
Functional MR with ejection fraction (EF) < 40%
Over 75 years old with EF < 40%
Prior re-operation with patent grafts
Two or more prior chest surgeries
Hepatic cirrhosis
Three or more of the following STS high risk factors:

Creatinine > 2.5 mg/dL ii. Prior chest surgery iii. Age over 75 iv. EF < 35%

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
High Risk Registry Arm	Experimental	Device: Percutaneous mitral valve repair using MitraClip implantIncludes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (17 listed)

Candidates for the high risk arm of the study must meet all of the following inclusion criteria:
Predicted procedural mortality risk calculated using the STS surgical risk calculator of ≥ 12% or in the judgment of the surgeon investigator the patient is considered a high risk surgical candidate due to the presence of one of the following indications:
Age 18 years or older.
Symptomatic moderate to severe (3+) or severe (4+) chronic mitral regurgitation (MR) and in the judgment of the investigator intervention to reduce MR is likely to provide symptomatic relief for the patient. MR is determined as defined in Appendix A of the EVEREST II study protocol. American Society of Anesthesiologists (ASA) physical status classification of ASA IV or lower.
The primary regurgitant jet originates from malcoaptation of the A2 and P2 scallops of the mitral valve.

Key exclusion criteria (28 listed)

Candidates will be excluded from the study if any of the following conditions are present:
Evidence of an acute myocardial infarction in the prior 2 weeks of the intended treatment (defined as: Q wave or non-Q wave infarction having creatine kinase (CK) enzymes ≥ two times (2X) the upper laboratory normal limit with the presence of a Creatine Kinase MB Isoenzyme (CKMB) elevated above the institution's upper limit of normal).
In the judgment of the Investigator, the femoral vein cannot accommodate a 24 F catheter or presence of ipsilateral deep vein thrombosis (DVT).
Ejection fraction < 20%, and/or end-systolic dimension > 60 mm as defined in Appendix A of the EVEREST II protocol.
Mitral valve orifice area < 4.0 cm2 as defined in Appendix A of the EVEREST II protocol.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Percutaneous mitral valve repair using MitraClip implantAlso: MitraClip, MitraClip ImplantProcedure/Surgery: Mitral valve repair or replacement surgery Repair or replacement of mitral valve	Device	High Risk Registry Arm

Primary outcome

Composite Functional and Structural Measures - Freedom From Death
Time frame: 12 months
Defined as all causes of death for the primary safety Major Adverse Event (MAE) Endpoint. Death is further divided into 2 categories: A. Cardiac death is defined as death due to any of the following: 1. Acute myocardial infarction. 2. Cardiac perforation/pericardial tamponade. 3. Arrhythmia or conduction abnormality. 4. Stroke within 30 days of the procedure or stroke suspected of being related to the procedure. 5. Death due to any complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery. 6. Any death for which a cardiac cause cannot be excluded. B. Non-cardiac death is defined as a death not due to cardiac causes (as defined above).
Percentage of Participants With Freedom From Death and Mitral Regurgitation (MR) >2+
Time frame: 12 months
Kaplan-Meier estimated percentage of patients who are alive and have a mitral regurgitation severity grade of 2+ or less
Number of Participants With Clinical Measures of Benefit-New York Heart Association (NYHA) Class
Time frame: 30 days
The major effectiveness endpoint is an assessment of multiple functional and structural measures of benefit including New York Heart Association (NYHA) Class. Class I: Patients with cardiac disease but without resulting limitations of physical activity. Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain. Class III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain. Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased.
Number of Participants With New York Heart Association (NYHA) Class
Time frame: 12 months
Class I: Patients with cardiac disease but without resulting limitations of physical activity. Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain. Class III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain. Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased.
Clinical Measures of Benefit-Quality of Life (QOL) as Measured by Short Form (SF) 36
Time frame: 12 months
Standardized quality of life surveys allow physicians to evaluate the effectiveness of different treatment methods and the physical and psychological benefits a patient is likely to receive from a particular treatment.In the EVEREST II HRR,the patients were asked to complete the SF-36 QOL survey at baseline, 30 days and 12 months. The physical \& mental function were assessed by the Physical Component Summary (PCS) score \& Mental Component Summary (MCS) score. The PCS \& MCS norms for 65-75 year olds are 44 and 52 respectively; and 31 \& 46 for congestive heart failure (CHF) patients respectively. Each scale from the SF-36 is an algebraic sum of responses for all items in that scale.For ease of analysis each scale is then transformed to a 0-100 scale using a formula that converts the lowest \& highest possible scores to 0 \& 100 respectively.The scoring of the SF-36 indicates that 0% in a domain represents the poorest possible QoL \& 100% indicates full QoL.
Left Ventricular End Diastolic Volume (LVEDV)
Time frame: 12 months
Left Ventricular End Diastolic Volume (LVEDV) as determined by the core echocardiography laboratory from a transthoracic echocardiogram (TTE).
Left Ventricular End Systolic Volume (LVESV)
Time frame: 12 months
Left Ventricular End Systolic Volume (LVESV) as determined by the core echocardiography laboratory from a transthoracic echocardiogram (TTE).
Left Ventricular (LV) Function - Internal Dimension
Time frame: 12 months
Left Ventricular Internal Dimension in diastole (LVIDd) and Left Ventricular Internal Dimension in systole (LVIDs) as determined by the core echocardiography laboratory from a transthoracic echocardiogram (TTE).
Number of Patients With CHF Having Hospitalization During Discharge Through 12 Months
Time frame: 12 months
Number of patients with incidence of re-hospitalizations for CHF in the 12-months after the MitraClip implant procedure.
Number of CHF Events Leading to Hospitalizations During Discharge Through 12 Months
Time frame: 12 months
Incidence of re-hospitalizations for CHF in the 12-months after the MitraClip implant procedure.
Left Ventricular End Diastolic Volume (LVEDV)
Time frame: Discharge or 30 days
Left Ventricular End Diastolic Volume (LVEDV) as determined by the core echocardiography laboratory from a transthoracic echocardiogram (TTE).
Left Ventricular End Systolic Volume (LVESV)
Time frame: Discharge or 30 days
Left Ventricular End Systolic Volume (LVESV) as determined by the core echocardiography laboratory from a transthoracic echocardiogram (TTE).
Left Ventricular (LV) Function - Internal Dimension
Time frame: Discharge or 30 days
Left Ventricular Internal Dimension in diastole (LVIDd) and Left Ventricular Internal Dimension in systole (LVIDs) as determined by the core echocardiography laboratory from a transthoracic echocardiogram (TTE).

138 secondary outcomes

Number of Participants Experiencing Major Adverse Events (MAE)
Time frame: 30 days
Number of Participants Experiencing Major Adverse Events
Time frame: 12 months
Procedural Freedom From In-hospital MAE
Time frame: 30 Days
Number of Participants Over 75 Years of Age With MAE
Time frame: 30 days
Number of Participants Over 75 Years of Age With MAE
Time frame: 12 months
Number of Participants Experiencing Major Vascular Complications
Time frame: 30 days
Number of Participants Experiencing Major Vascular Complications
Time frame: 12 months
Number of Participants With Major Bleeding Complications
Time frame: 30 days
Number of Participants With Major Bleeding Complications
Time frame: 12 months
Number of Participants With Non-cerebral Thromboembolism
Time frame: 30 days
Number of Participants With Non-cerebral Thromboembolism
Time frame: 12 months
Number of Participants With Thrombosis
Time frame: 30 days
Number of Participants With Thrombosis
Time frame: 12 months
Number of Participants With Hemolysis
Time frame: 30 days
Number of Participants With Hemolysis
Time frame: 12 months
Number of Participants With Dysrhythmias
Time frame: 30 days
Number of Participants With Dysrhythmias
Time frame: 12 months
Number of Participants With Endocarditis
Time frame: 30 days
Number of Participants With Endocarditis
Time frame: 12 months
Number of Participants With Atrial Septal Defect (ASD)
Time frame: 30 days
Number of Participants With Atrial Septal Defect (ASD)
Time frame: 12 months
Number of Participants With Mitral Valve Stenosis
Time frame: 30 days
Number of Participants With Mitral Valve Stenosis
Time frame: 12 months
Number of Participants With Mitral Valve Stenosis
Time frame: 24 months
Number of Participants With Mitral Valve Stenosis
Time frame: 36 months
Number of Participants With Mitral Valve Stenosis
Time frame: 48 months
Mitral Valve Area: By Planimetry
Time frame: 30 days
Mitral Valve Area: By Planimetry
Time frame: 12 months
Mitral Valve Area: By Planimetry
Time frame: 24 months
Mitral Valve Area: By Planimetry
Time frame: 36 months
Mitral Valve Area: By Planimetry
Time frame: 48 months
Mitral Valve Area: By Planimetry
Time frame: 60 months
Mitral Valve Area: By Pressure Half-time
Time frame: 30 days
Mitral Valve Area: By Pressure Half-time
Time frame: 12 months
Mitral Valve Area: By Pressure Half-time
Time frame: 24 months
Mitral Valve Area: By Pressure Half-time
Time frame: 36 months
Mitral Valve Area: By Pressure Half-time
Time frame: 48 months
Mitral Valve Area: By Pressure Half-time
Time frame: 60 months
Mitral Valve Area Index : By Planimetry
Time frame: 30 days
Mitral Valve Area Index : By Planimetry
Time frame: 12 months

Results and safety

Results posted to the registry on 16 Jan 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
High Risk Registry Arm	78	30

Primary outcome: Composite Functional and Structural Measures - Freedom From Death

Time frame: 12 months. Count of participants. Unit: Participants

Measure	High Risk Registry Arm n = 78
Value	59

Primary outcome: Percentage of Participants With Freedom From Death and Mitral Regurgitation (MR) >2+

Time frame: 12 months. Number. Unit: percentage of participants

Measure	High Risk Registry Arm n = 78
Primary Analysis	56.4
Worst case Analysis	53.8

Primary outcome: Number of Participants With Clinical Measures of Benefit-New York Heart Association (NYHA) Class

Time frame: 30 days. Count of participants. Unit: Participants

Measure	High Risk Registry Arm n = 71
NYHA Functional Class I	14
NYHA Functional Class II	38
NYHA Functional Class III	16
NYHA Functional Class IV	3

Population analysed: 71 out of 78 patients (at baseline) were analyzed at 30 days. There were 6 deaths prior to 30 days. So, NYHA at 30 days is missing due to death in 6 patients, and missing due to other reasons in 1 patient.

Primary outcome: Number of Participants With New York Heart Association (NYHA) Class

Time frame: 12 months. Count of participants. Unit: Participants

Measure	High Risk Registry Arm n = 54
NYHA Functional Class I	18
NYHA Functional Class II	22
NYHA Functional Class III	13
NYHA Functional Class IV	1

Population analysed: Of 78 total population, 54 participants were included in the analysis population because of 18 deaths within 1 year, 3 withdrawals, 1 missed visit and 2 patients without NYHA Class assessment.

138 secondary outcomes are reported in the full results.

Adverse events

Time frame: 5 years. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
High Risk Registry Arm	69 of 78 (88.5%)	77 of 78 (98.7%)	25 of 78

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 30586701Ailawadi G, Lim DS, Mack MJ, Trento A, Kar S, Grayburn PA, Glower DD, Wang A, Foster E, Qasim A, Weissman NJ, Ellis J, Crosson L, Fan F, Kron IL, Pearson PJ, Feldman T; EVEREST II Investigators. One-Year Outcomes After MitraClip for Functional Mitral Regurgitation. Circulation. 2019 Jan 2;139(1):37-47. doi: 10.1161/CIRCULATIONAHA.117.031733.
Derived from this study: PubMed 30077993Kar S, Feldman T, Qasim A, Trento A, Kapadia S, Pedersen W, Lim DS, Kipperman R, Smalling RW, Bajwa T, Hermann HC, Hermiller JB, Lasala JM, Reisman M, Glower D, Mauri L, Whitlow P; EVEREST II Investigators. Five-year outcomes of transcatheter reduction of significant mitral regurgitation in high-surgical-risk patients. Heart. 2019 Nov;105(21):1622-1628. doi: 10.1136/heartjnl-2017-312605. Epub 2018 Aug 4.
Derived from this study: PubMed 25593120Wang A, Sangli C, Lim S, Ailawadi G, Kar S, Herrmann HC, Grayburn P, Foster E, Weissman NJ, Glower D, Feldman T. Evaluation of renal function before and after percutaneous mitral valve repair. Circ Cardiovasc Interv. 2015 Jan;8(1):e001349. doi: 10.1161/CIRCINTERVENTIONS.113.001349.
Sponsor informationLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Ted Feldman, M.D. principal investigator

Endeavor Health

Donald G Glower Jr.,, M.D. principal investigator

Duke University Medical Center, Department of Surgery

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Jan 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Composite Functional and Structural Measures - Freedom From Death (time frame: 12 months). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01940120, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2018.