Mitral Valve InsufficiencyEVERESTIIRCTNCT00209274

Pivotal Study of a Percutaneous Mitral Valve Repair System

A study testing Percutaneous mitral valve repair using MitraClip implant and Mitral valve repair or replacement surgery in people with Mitral Valve Insufficiency and Mitral Valve Regurgitation, run by Abbott Medical Devices at 1 site 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

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 and Mitral valve repair or replacement surgery
Type of treatment: Medical device, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 279 participants
Where: 1 siteUnited States
Study dates: Aug 2005to Dec 2014
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

Patients with Grade 3 (moderate to severe) or Grade 4 (severe) mitral regurgitation (MR) based on American Society of Echocardiography guidelines:
Are 18 years or older.
Symptomatic
If asymptomatic, must have new onset of atrial fibrillation, pulmonary hypertension, or evidence of left ventricular dysfunction
Are candidates for mitral valve surgery
Are candidates for transseptal catheterization

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Primary regurgitant jet must originate from malcoaptation of the A2 and P2 scallops of the mitral valve
Appropriate valve anatomy for MitraClip
Does not need other cardiac surgery or any emergency surgery
Did not experience myocardial infarction in prior 12 weeks or endovascular procedure in prior 30 days
Mitral valve orifice area ≥ 4 cm2
Do not have renal insufficiency
Echocardiographic evidence of intracardiac mass, thrombus or vegetation

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

Evanston Northwestern Healthcare
Evanston, Illinois, 60201

Other trials in United States

About this study

Official title: Pivotal Study: A Study of the Evalve Cardiovascular Valve Repair System - Endovascular Valve Edge-to-Edge REpair STudy (EVERESTIIRCT)

EVEREST II Randomized Controlled Trial (RCT) is a prospective, multi-center, randomized study of the MitraClip® System in the treatment of mitral valve regurgitation, randomizing patients to MitraClip or mitral valve surgery. The EVEREST II High Risk Registry (HRR) study is a prospective multi-center study of the MitraClip System for the treatment of mitral valve regurgitation in high surgical risk patients. Enrollment in the RCT and HRR is closed. A continued access prospective, multi-center study (REALISM) of the MitraClip System in a surgical population (non-high risk arm) and a high surgical risk population (high risk arm) is ongoing. Enrollment in the non-high risk arm of REALISM is closed. Enrollment in the high risk arm of REALISM is ongoing. Patients enrolled in EVEREST II undergo 30-day, 6-month, 12-month, 18-month and 24-month clinical and echocardiographic follow-up, and then annually for 5 years.

Read the detailed description

Prospective, multi-center, randomized study of the safety and effectiveness of an endovascular approach to the treatment of mitral valve regurgitation using the Evalve Cardiovascular Valve Repair System (MitraClip® implant).

A minimum of 279 evaluable patients randomized 2:1 to MitraClip or mitral valve surgery, respectively, are required to test the primary safety and effectiveness endpoints of the RCT. Enrollment in the RCT is now complete. 60 roll-in patients were enrolled under EVEREST II RCT.

38 clinical sites throughout the US and Canada have participated in the RCT and HRR. 37 US sites are participating in REALISM.

The RCT is powered to test the hypothesis MitraClip has both superiority of safety and non-inferiority of effectiveness compared to mitral valve repair or replacement surgery. The HRR is powered to show lower mortality at 30 days with the MitraClip than predicted surgical mortality.

Conditions: Mitral Valve Insufficiency, Mitral Valve Regurgitation, Mitral Valve Incompetence, Mitral Regurgitation, Mitral Insufficiency
Being tested: Percutaneous mitral valve repair using MitraClip implant, Mitral valve repair or replacement surgery
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, CAD - Coronary Artery Disease, 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
Mitral valve repair or replacement surgeryProcedure or surgery
Repair or replacement of mitral valve

Study groups in NCT00209274
Study group	Role	What they receive
1	Experimental	Percutaneous mitral valve repair using MitraClip implant. The calculated sample size was 186 patients in the device arm Receives: Device: Percutaneous mitral valve repair using MitraClip implant
2	Active comparator	Mitral valve repair or replacement surgery. The calculated sample size was 93 patients in the control arm. Receives: Procedure: Mitral valve repair or replacement surgery

What is being measured

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

Number of Participants With Major Adverse Events (MAE)
Defined as a 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, gastrointestinal (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 With Freedom From Surgery for Valve Dysfunction, Death, and Moderate to Severe (3+) or Severe (4+) Mitral Regurgitation (MR).
Measured: 12 months

Secondary outcomes (155)

Freedom From All-Cause Mortality
Measured: 12 months
Freedom From All-Cause Mortality
Measured: 24 months
Freedom From All-Cause Mortality
Measured: 3 years
Freedom From All-Cause Mortality
Measured: 4 years
Freedom From All-Cause Mortality
Measured: 5 years
Number of Participants With Freedom From Surgery for Valve Dysfunction, Death, and Moderate to Severe (3+) or Severe (4+) Mitral Regurgitation.
Measured: 12 months
Number of Participants With Freedom From Surgery for Valve Dysfunction, Death, and Moderate to Severe (3+) or Severe (4+) Mitral Regurgitation (MR).
Measured: 24 months
Number of Participants With Freedom From Surgery for Valve Dysfunction, Death, and Moderate to Severe (3+) or Severe (4+) Mitral Regurgitation (MR) in Intention to Treat Strategy Cohort
Measured: 24 months
Left Ventricular Ejection Fraction (LVEF)
LVEF as determined by the core echo laboratory at 30 days or hospital discharge, whichever is longer.
Measured: At discharge (≤ 14 days following index procedure) or 30 days
Left Ventricular Ejection Fraction (LVEF)
LVEF as determined by the core echo laboratory.
Measured: 12 months
Left Ventricular Ejection Fraction (LVEF)
LVEF as determined by the core echo laboratory.
Measured: 24 months
Left Ventricular Ejection Fraction (LVEF)
LVEF as determined by the core echo laboratory.
Measured: 3 years
Left Ventricular Ejection Fraction (LVEF)
LVEF as determined by the core echo laboratory.
Measured: 4 years
Left Ventricular Ejection Fraction (LVEF)
LVEF as determined by the core echo laboratory.
Measured: 5 years
Left Ventricular Status- Left Ventricular End-diastolic Volume (LVEDV), Left Ventricular End-systolic Volume (LVESV)
Left Ventricular Status includes Left ventricular (LV) end-diastolic volume (LVEDV), LV end-systolic volume (LVESV), as determined by the core echo laboratory at 30 days or hospital discharge, whichever is longer.
Measured: 30 days
Left Ventricular Status- LVEDV, LVESV
Left Ventricular Status includes LV end-diastolic volume (LVEDV), LV end-systolic volume (LVESV),as determined by the core echo laboratory at 12 months.
Measured: 12 months
Left Ventricular Status- LVEDV, LVESV
Left Ventricular Status includes LV end-diastolic volume (LVEDV), LV end-systolic volume (LVESV), as determined by the core echo laboratory at 24 months.
Measured: 24 months
Left Ventricular Status- LVEDV, LVESV
Left Ventricular Status includes LV end-diastolic volume (LVEDV), LV end-systolic volume (LVESV), as determined by the core echo laboratory at 3 years.
Measured: 3 years
Left Ventricular Status- LVEDV, LVESV
Left Ventricular Status includes LV end-diastolic volume (LVEDV), LV end-systolic volume (LVESV), as determined by the core echo laboratory at 4 years
Measured: 4 years
Left Ventricular Status- LVEDV, LVESV
Left Ventricular Status includes LV end-diastolic volume (LVEDV), LV end-systolic volume (LVESV), as determined by the core echo laboratory at 5 years.
Measured: 5 years
Left Ventricular Internal Dimension Systole (LVIDs)
Left Ventricular internal dimension systole (LVIDs) as determined by the core echo laboratory.
Measured: 30 days
Left Ventricular Internal Dimension Systole (LVIDs)
Left Ventricular internal dimension systole (LVIDs) as determined by the core echo laboratory.
Measured: 12 months
Left Ventricular Internal Dimension Systole (LVIDs)
Left Ventricular internal dimension systole (LVIDs) as determined by the core echo laboratory.
Measured: 2 years
Left Ventricular Internal Dimension Systole (LVIDs)
Left Ventricular internal dimension systole (LVIDs) as determined by the core echo laboratory.
Measured: 3 years
Left Ventricular Internal Dimension Systole (LVIDs)
Left Ventricular internal dimension systole (LVIDs) as determined by the core echo laboratory.
Measured: 4 years
Left Ventricular Internal Dimension Systole (LVIDs)
Left Ventricular internal dimension systole (LVIDs) as determined by the core echo laboratory.
Measured: 5 years
Left Ventricular Internal Dimension Diastole (LVIDd)
Left Ventricular internal dimension diastole (LVIDd) as determined by the core echo laboratory.
Measured: 30 days
Left Ventricular Internal Dimension Diastole (LVIDd)
Left Ventricular internal dimension diastole (LVIDd) as determined by the core echo laboratory at 12 months.
Measured: 12 months
Left Ventricular Internal Dimension Diastole (LVIDd)
Left Ventricular internal dimension diastole (LVIDd) as determined by the core echo laboratory at 24 months.
Measured: 24 months
Left Ventricular Internal Dimension Diastole (LVIDd)
Left Ventricular internal dimension diastole (LVIDd) as determined by the core echo laboratory at 3 years.
Measured: 3 years
Left Ventricular Internal Dimension Diastole (LVIDd)
Left Ventricular internal dimension diastole (LVIDd) as determined by the core echo laboratory at 4 years.
Measured: 4 years
Left Ventricular Internal Dimension Diastole (LVIDd)
Left Ventricular internal dimension diastole (LVIDd) as determined by the core echo laboratory at 5 years.
Measured: 5 years
Number of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease.
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: Baseline
Number of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease.
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) Functional Class Cardiac Disease.
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
Number of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease.
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 New York Heart Association (NYHA) Functional Class Cardiac Disease.
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: 3 years
Number of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease.
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: 4 years
Number of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease.
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: 5 years
New York Heart Association (NYHA) Functional Class Cardiac Disease: NYHA Functional Class III or IV
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
Percentage of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease: NYHA Functional Class III or IV
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
Percentage of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease: NYHA Functional Class III or IV
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: 2 years
Percentage of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease: NYHA Functional Class III or IV
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: 3 years
Percentage of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease: NYHA Functional Class III or IV
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: 4 years
Percentage of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease: NYHA Functional Class III or IV
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: 5 years
Short Form (SF)-36 Quality of Life Questionnaire.
The SF-36 is a multidimensional, patient-reported survey containing 36 questions on a 0-100 scale measuring physical (Physical Component Score) \& mental health status (Mental Component Score) in relation to 8 health concepts: physical functioning, role limitations due to physical or emotional health, bodily pain, general health perceptions, vitality, social functioning, \& general mental health. Responses to each of the SF-36 items are scored and expressed as a score on a 0-100 scale (0% in a domain represents the poorest possible QOL\&100% indicates full QOL).Higher scores represent better self-perceived health.
The physical \& mental functions were assessed by the Physical Component Summary (PCS) score \& Mental Component Summary (MCS) score. Normal PCS and MCS scores vary depending on the demographics of the population studied. The PCS\&MCS norms for 65-75 year old are 44 \& 52, respectively while the norms for CHF population are 31 \& 46, respectively.
Measured: 30 days
Short Form (SF)-36 Quality of Life Questionnaire.
The SF-36 is a multidimensional, patient-reported survey containing 36 questions on a 0-100 scale measuring physical (Physical Component Score) \& mental health status (Mental Component Score) in relation to 8 health concepts: physical functioning, role limitations due to physical or emotional health, bodily pain, general health perceptions, vitality, social functioning, \& general mental health. Responses to each of the SF-36 items are scored and expressed as a score on a 0-100 scale (0% in a domain represents the poorest possible QOL\&100% indicates full QOL).Higher scores represent better self-perceived health.
The physical \& mental functions were assessed by the Physical Component Summary (PCS) score \& Mental Component Summary (MCS) score. Normal PCS and MCS scores vary depending on the demographics of the population studied. The PCS\&MCS norms for 65-75 year old are 44 \& 52, respectively while the norms for CHF population are 31 \& 46, respectively.
Measured: 12 months
Cardiac Output
Cardiac output as measured by core lab echocardiography.
Measured: 30 days
Cardiac Output
Cardiac output as measured by core lab echocardiography.
Measured: 12 months
Cardiac Output
Cardiac output as measured by core lab echocardiography.
Measured: 24 months
Cardiac Index
Defined as cardiac output divided by body surface area, as measured by core lab echocardiography.
Measured: 30 days
Cardiac Index (CI)
Defined as cardiac output divided by body surface area as measured by core lab echocardiography. CI is a normalization of cardiac output to take into account the effect of body size on cardiac output requirements.
Measured: 12 months
Cardiac Index
Defined as cardiac output divided by body surface area, as measured by core lab echocardiography.
Measured: 24 months
Regurgitant Volume
Regurgitant volume as determined by the core echo laboratory. In the presence of regurgitation of one valve, without any intracardiac shunt, the flow through the affected valve is larger than through other competent valves. The difference between the two represents the regurgitant volume.
Measured: 30 Days
Regurgitant Volume
Regurgitant volume as determined by the core echo laboratory.
Measured: 12 months
Regurgitant Volume
Regurgitant volume as determined by the core echo laboratory.
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
Regurgitant fraction is defined as the percentage of the left ventricular (LV) stroke volume that regurgitates into the left atrium.
Measured: 12 months
Regurgitant Fraction
Regurgitant fraction is defined as the percentage of the left ventricular (LV) stroke volume that regurgitates into the left atrium.
Measured: 24 months
Number of Participants With Clip Implant Rate
Defined as the rate of successful implantation of MitraClip(s).
Measured: Day 0
Number of Participants With Acute Procedural Success
Defined as successful MitraClip implantation with resulting MR of 2+ or less.
Measured: 30 Days
Number of Participants With Acute Surgical Success
Defined as successful mitral valve repair or replacement surgery.
Measured: 30 Days
Number of Participants With Successful Clip Implant and Acute Procedural Success
Acute procedural success is defined as MR severity ≤ 2 at discharge or 1 grade MR reduction at discharge accompanied by 1 level NYHA reduction.
Measured: 30 days
Number of Participants With 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.
Defined as freedom from mitral valve replacement surgery for Valve Dysfunction, death, re-operation, and MR > 2+ at 12 months.
Measured: 24 months
Number of Participants With Procedural Freedom From In-hospital MAE.
Measured: Day 0
Number of Participants With Procedural Freedom From In-hospital MAE
Measured: Day 30
Number of Participants With MAE: Surgery After Device and First Time Surgery Control
Measured: 30 days
Number of Participants With Major Vascular Complications
Vascular Complications defined as the occurrence of any of the following resulting through 30 days or hospital discharge, whichever is longer:
- Hematoma at access site >6 cm;
- Retroperitoneal hematoma;
- Arteriovenous (AV) fistula;
- Symptomatic peripheral ischemia / nerve injury or the clinical signs or symptoms lasting >48 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 With Major Vascular Complications
Vascular Complications defined as the occurrence of any of the following resulting through 30 days or hospital discharge, whichever is longer:
- Hematoma at access site >6 cm;
- Retroperitoneal hematoma;
- Arteriovenous (AV) fistula;
- Symptomatic peripheral ischemia / nerve injury or the clinical signs or symptoms lasting >48 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.
Major Bleeding Complications defined as procedure related bleeding that requires a transfusion of ≥2 units of blood products and/or surgical intervention at 30 days or hospital discharge, whichever is longer.
Measured: 30 days
Number of Participants With Major Bleeding Complications.
Major Bleeding Complications defined as procedure related bleeding that requires a transfusion of ≥2 units of blood products and/or surgical intervention at 12 months.
Measured: 12 months
Number of Participants With Major Adverse Events (MAE)
Measured: 12 months.
Number of Participants With MAE in Patients Over 75 Years of Age.
Measured: 30 days
Number of Participants With MAE in Patients Over 75 Years of Age.
Measured: 12 months
Number of Participants With Dysrhythmia
Measured: 30 days
Number of Participants With Dysrhythmia
Measured: 12 months
Number of Participants With Endocarditis.
Defined as a diagnosis of endocarditis based on the Duke criteria. Infection in the lining of the heart, of the valves, or of the muscles of the heart. Signs of endocarditis may include persistent positive blood cultures and/or valvular structural abnormality and vegetations as seen using echocardiography.
Measured: 30 days
Number of Participants With Endocarditis.
Defined as a diagnosis of endocarditis based on the Duke criteria. Infection in the lining of the heart, of the valves, or of the muscles of the heart. Signs of endocarditis may include persistent positive blood cultures and/or valvular structural abnormality and vegetations as seen using echocardiography.
Measured: 12 months
Number of Participants With Thrombosis.
Defined as evidence of the formation of an independently moving thrombus on any part of the MitraClip or any commercially available implant used during surgery by echocardiography or fluoroscopy.
Measured: 30 days
Number of Participants With Thrombosis.
Defined as evidence of the formation of an independently moving thrombus on any part of the MitraClip or any commercially available implant used during surgery by echocardiography or fluoroscopy.
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 repeat measures within 24 hours or on one measure if intervention is initiated based on other clinical symptoms. Reported as major or minor as defined below:
Major: Requires intervention with red blood cell transfusion or other hematocrit increasing measures in the absence of other obvious bleeding.
Minor: Does not require intervention.
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 repeat measures within 24 hours or on one measure if intervention is initiated based on other clinical symptoms. Reported as major or minor as defined below:
Major: Requires intervention with red blood cell transfusion or other hematocrit increasing measures in the absence of other obvious bleeding.
Minor: Does not require intervention.
Measured: 12 months
Number of Participants With Clinically Significant Atrial Septal Defect (ASD).
Defined as a significant residual atrial septal opening. Reported as clinically significant if intervention is performed for the primary purpose of repairing the ASD. If cardiac surgery is indicated for reasons other than residual ASD (e.g., residual MR) and the ASD is repaired at the same time, this does not meet the definition of clinically significant ASD.
Measured: 30 days
Number of Participants With Clinically Significant Atrial Septal Defect (ASD)
Defined as a significant residual atrial septal opening. Reported as clinically significant if intervention is performed for the primary purpose of repairing the ASD. If cardiac surgery is indicated for reasons other than residual ASD (e.g., residual MR) and the ASD is repaired at the same time, this does not meet the definition of clinically significant ASD.
Measured: 12 months
Number of Participants With Mitral Valve Stenosis
Defined as a mitral valve planimetered orifice area of less than 1.5 cm^2 as measured by echocardiography.
Measured: 30 days
Number of Participants With Mitral Valve Stenosis
Defined as a mitral valve planimetered orifice area of less than 1.5 cm^2 as measured by echocardiography.
Measured: 12 months
Number of Participants With Mitral Valve Stenosis
Defined as a mitral valve planimetered orifice area of less than 1.5 cm^2 as measured by echocardiography.
Measured: 24 months
Number of Participants With Mitral Valve Stenosis
Defined as a mitral valve (MV) planimetered orifice area of less than 1.5 cm^2 as measured by echocardiography. A "confirmed" case of MV stenosis is defined as Echocardiography Core Lab (ECL) measured mitral valve orifice area < 1.5 cm^2. A "conservative" case of MV stenosis is defined as stenosis suspected by the site, based on hemodynamic measurements or clinical symptoms.
Measured: 3 years
Number of Participants With Mitral Valve Stenosis
Defined as a mitral valve (MV) planimetered orifice area of less than 1.5 cm^2 as measured by echocardiography. A "confirmed" case of MV stenosis is defined as Echocardiography Core Lab (ECL) measured mitral valve orifice area < 1.5 cm^2. A "conservative" case of MV stenosis is defined as stenosis suspected by the site, based on hemodynamic measurements or clinical symptoms.
Measured: 4 years
Number of Participants With Mitral Valve Stenosis
Defined as a mitral valve (MV) planimetered orifice area of less than 1.5 cm^2 as measured by echocardiography. A "confirmed" case of MV stenosis is defined as Echocardiography Core Lab (ECL) measured mitral valve orifice area < 1.5 cm^2. A "conservative" case of MV stenosis is defined as stenosis suspected by the site, based on hemodynamic measurements or clinical symptoms.
Measured: 5 years
Mitral Valve Area by Planimetry
Mitral valve area as measured by core lab echocardiography.
Measured: At Discharge (≤14 days of index procedure)
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: 3 years
Mitral Valve Area by Planimetry
Mitral valve area as measured by core lab echocardiography.
Measured: 4 years
Mitral Valve Area by Planimetry
Mitral valve area as measured by core lab echocardiography.
Measured: 5 years
Mitral Valve Area by Planimetry Index
Defined as mitral valve area divided by body surface area as measured by core lab echocardiography.
Measured: 30 Days
Mitral Valve Area by Planimetry Index
Defined as mitral valve area divided by body surface area as measured by core lab echocardiography.
Measured: 12 months
Mitral Valve Area by Planimetry Index
Defined as mitral valve area divided by body surface 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: At Discharge (≤14 days of index procedure)
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: 3 years
Mitral Valve Area by Pressure Half-time
Mitral valve area as measured by core lab echocardiography.
Measured: 4 years
Mitral Valve Area by Pressure Half-time
Mitral valve area as measured by core lab echocardiography.
Measured: 5 years
Mitral Valve Area by Pressure Half-time Index
Defined as mitral valve area divided by body surface area as measured by core lab echocardiography.
Measured: 30 Days
Mitral Valve Area by Pressure Half-time Index
Defined as mitral valve area divided by body surface area as measured by core lab echocardiography.
Measured: 12 months
Mitral Valve Area by Pressure Half-time Index
Defined as mitral valve area divided by body surface area as measured by core lab echocardiography.
Measured: 24 months
Transvalvular Mitral Valve Gradient
Defined as the mean pressure gradient across the mitral valve as measured by echocardiography.
Measured: At Discharge (≤ 14 days following index procedure)
Transvalvular Mitral Mean Pressure Gradient (Mean MVG)
Defined as the mean pressure gradient across the mitral valve as measured by Echocardiography Core Laboratory (ECL).
Measured: 12 months
Transvalvular Mitral Mean Pressure Gradient (Mean MVG)
Defined as the mean pressure gradient across the mitral valve as measured by echocardiography.
Measured: 24 months
Transvalvular Mitral Mean Pressure Gradient (Mean MVG)
Defined as the mean pressure gradient across the mitral valve as measured by echocardiography.
Measured: 3 year
Transvalvular Mitral Mean Pressure Gradient (Mean MVG)
Defined as the mean pressure gradient across the mitral valve as measured by echocardiography.
Measured: 4 year
Transvalvular Mitral Mean Pressure Gradient (Mean MVG)
Defined as the mean pressure gradient across the mitral valve as measured by echocardiography.
Measured: 5 years
Post-procedure Length of Hospital Stay
Measured: 30 Days
Post-procedure Intensive Care Unit (ICU) / Critical Care Unit (CCU) Duration
Measured: 30 Days
Number of Participants With Hospital Re-admissions
Defined as re-admission to the hospital for any reason. The endpoint was intended to capture each time a patient was re-admitted to the hospital for any reason and was to be reported as a rate through 30 days for both the Device and Control groups.
Measured: 30 days
Number of Participants With Incidence of Discharge to a Nursing Home or Skilled Nursing Facility/Hospital
Measured: 30 Days
Number of Participants With Incidence of Hospital Readmissions for Congestive Heart Failure (CHF).
Measured: 30 days
Number of Participants With New Coumadin (Warfarin) Usage
Measured: 30 days
Number of Participants With New Coumadin (Warfarin) Usage
Measured: 12 months
Number of Participants With Durability of the MitraClip Device and Surgery.
Device group: Freedom from death, surgery for mitral valve dysfunction and MR > 2+ at the end of each follow-up interval.
Control group: Freedom from death, re-operation for mitral valve dysfunction and MR > 2+ at the end of each follow-up interval.
Measured: 12 months
Number of Participants With Durability of the MitraClip Device and Surgery.
Device group: Freedom from death, surgery for mitral valve dysfunction and MR > 2+ at the end of each follow-up interval.
Control group: Freedom from death, re-operation for mitral valve dysfunction and MR > 2+ at the end of each follow-up interval.
Measured: 12-18 months
Number of Participants With Durability of the MitraClip Device and Surgery.
Device group: Freedom from death, surgery for mitral valve dysfunction and MR > 2+ at the end of each follow-up interval.
Control group: Freedom from death, re-operation for mitral valve dysfunction and MR > 2+ at the end of each follow-up interval.
Measured: 18-24 months
Number of Participants With Durability of the MitraClip Device and Surgery.
Device group: Freedom from death, surgery for mitral valve dysfunction and MR > 2+ at the end of each follow-up interval.
Control group: Freedom from death, re-operation for mitral valve dysfunction and MR > 2+ at the end of each follow-up interval.
Measured: 24 months-3 year
Number of Participants With Freedom From Death, Mitral Valve Surgery/Re-operation and MR > 2+
Durability estimates: Freedom from Death, Mitral Valve Surgery/Re-operation and MR > 2+
Measured: 12 months
Number of Participants With Freedom From Death, Mitral Valve Surgery/Re-operation and MR > 2+
Durability estimates: Freedom from Death, Mitral Valve Surgery/Re-operation and MR > 2+
Measured: 24 months
Number of Participants With Freedom From Death, Mitral Valve Surgery/Re-operation and MR > 2+
Durability estimates: Freedom from Death, Mitral Valve Surgery/Re-operation and MR > 2+
Measured: 3 years
Number of Participants With Freedom From Mitral Valve Surgery/Re-operation
Durability estimates: Freedom from Mitral Valve Surgery/Re-operation
Measured: 12 months
Number of Participants With Freedom From Mitral Valve Surgery/Re-operation
Durability estimates: Freedom from Mitral Valve Surgery/Re-operation
Measured: 24 months
Number of Participants With Freedom From Mitral Valve Surgery/Re-operation
Durability estimates: Freedom from Mitral Valve Surgery/Re-operation
Measured: 3 years
Number of Participants With Freedom From Mitral Valve Surgery/Re-operation
Durability estimates: Freedom from Mitral Valve Surgery/Re-operation
Measured: 4 years
Number of Participants With Freedom From Mitral Valve Surgery/Re-operation
Durability estimates: Freedom from Mitral Valve Surgery/Re-operation
Measured: 5 years
Number of Participants With Freedom From Death and Mitral Valve Surgery/Re-operation
Durability estimates: Freedom from Death and Mitral Valve Surgery/Re-operation
Measured: 12 months
Number of Participants With Freedom From Death and Mitral Valve Surgery/Re-operation
Durability estimates: Freedom from Death and Mitral Valve Surgery/Re-operation
Measured: 24 months
Number of Participants With Freedom From Death and Mitral Valve Surgery/Re-operation
Durability estimates: Freedom from Death and Mitral Valve Surgery/Re-operation
Measured: 3 years
Number of Participants With Freedom From Death and Mitral Valve Surgery/Re-operation
Durability estimates: Freedom from Death and Mitral Valve Surgery/Re-operation
Measured: 4 years
Number of Participants With Freedom From Death and Mitral Valve Surgery/Re-operation
Durability estimates: Freedom from Death and Mitral Valve Surgery/Re-operation
Measured: 5 years
Number of Participants With MitraClip Device Embolization/Single Leaflet Device Attachment
Device Embolization is defined as the complete detachment of the MitraClip Device from one or both mitral leaflets. Single leaflet device attachment (SLDA) is defined as attachment of one mitral valve leaflet to the MitraClip device. The control group did not receive the MitraClip device.
Measured: 12 months
Number of Participants With MitraClip Device Embolization/Single Leaflet Device Attachment
Device Embolization is defined as the complete detachment of the MitraClip Device from one or both mitral leaflets. Single leaflet device attachment (SLDA) is defined as attachment of one mitral valve leaflet to the MitraClip device. The control group did not receive the MitraClip device
Measured: 12 months to 3 years
Number of Participants With MitraClip Device Embolization/Single Leaflet Device Attachment
Device Embolization is defined as the complete detachment of the MitraClip Device from one or both mitral leaflets. Single leaflet device attachment (SLDA) is defined as attachment of one mitral valve leaflet to the MitraClip device. The control group did not receive the MitraClip device
Measured: 12 months to 4 years
Number of Participants With MitraClip Device Embolization/Single Leaflet Device Attachment
Device Embolization is defined as the complete detachment of the MitraClip Device from one or both mitral leaflets. Single leaflet device attachment (SLDA) is defined as attachment of one mitral valve leaflet to the MitraClip device. The control group did not receive the MitraClip device
Measured: 12 months to 5 years
Number of Participants With Non-cerebral Thromboembolism.
Defined as any thrombus or thromboembolism in the vasculature (excluding central nervous system events) or on the investigational device or any commercially available implant used during surgery confirmed by standard clinical and laboratory testing and which requires treatment.
Measured: 12 months
Number of Participants With MR Severity
MR Severity of 0: None,1+: Mild, 2+: Moderate, 3+: Moderate-to-Severe, 4+: Severe.
"Discharge" refers to each individual patient's date of hospital discharge. The discharge date varies for each patient, but in general, discharge occurs before 30-days follow-up. A 30-day echocardiogram will be used if the discharge echocardiogram is unavailable or otherwise uninterpretable.
Measured: 30 days
Number of Participants With MR Severity
MR Severity of 0: None,1+: Mild, 2+: Moderate, 3+: Moderate-to-Severe, 4+: Severe
Measured: 12 months
Number of Participants With MR Severity
MR Severity of 0: None,1+: Mild, 2+: Moderate, 3+: Moderate-to-Severe, 4+: Severe
Measured: 24 months
Number of Participants With MR Severity
MR Severity of 0: None,1+: Mild, 2+: Moderate, 3+: Moderate-to-Severe, 4+: Severe
Measured: 3 years
Number of Participants With MR Severity
MR Severity of 0: None,1+: Mild, 2+: Moderate, 3+: Moderate-to-Severe, 4+: Severe
Measured: 4 years
Number of Participants With MR Severity
MR Severity of 0: None,1+: Mild, 2+: Moderate, 3+: Moderate-to-Severe, 4+: Severe
Measured: 5 years
Number of Participants With Non-cerebral Thromboembolism.
Defined as any thrombus or thromboembolism in the vasculature (excluding central nervous system events) or on the investigational device or any commercially available implant used during surgery confirmed by standard clinical and laboratory testing and which requires treatment.
Measured: 30 days
Number of Participants With Incidence of Mitral Valve Replacement
Measured: 12 months
Number of Participants With Incidence of Mitral Valve Replacement
Measured: 24 months

Timeline

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

Aug 2005Dec 2014

First posted21 Sep 2005 (estimated)
Study startAug 2005
Primary completionNov 2009
Study completionDec 2014

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 (39)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: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 279 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00209274
Sponsor's protocol ID: Protocol #0401
Other IDs: Protocol #0401
Acronym: EVERESTIIRCT
Status last verified: Nov 2018
First submitted: 13 Sep 2005
Last updated: 7 Nov 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Fann JI, St Goar FG, Komtebedde J, Oz MC, Block PC, Foster E, Butany J, Feldman T, Burdon TA. Beating heart catheter-based edge-to-edge mitral valve procedure in a porcine model: efficacy and healing response. Circulation. 2004 Aug 24;110(8):988-93. doi: 10.1161/01.CIR.0000139855.12616.15. Epub 2004 Aug 9.
PubMed 15302782
St Goar FG, Fann JI, Komtebedde J, Foster E, Oz MC, Fogarty TJ, Feldman T, Block PC. Endovascular edge-to-edge mitral valve repair: short-term results in a porcine model. Circulation. 2003 Oct 21;108(16):1990-3. doi: 10.1161/01.CIR.0000096052.78331.CA. Epub 2003 Oct 6.
PubMed 14530193
Borgia F, Di Mario C, Franzen O. Adenosine-induced asystole to facilitate MitraClip placement in a patient with adverse mitral valve morphology. Heart. 2011 May;97(10):864. doi: 10.1136/hrt.2010.208132. Epub 2010 Oct 29. No abstract available.
PubMed 21036802
Tamburino C, Imme S, Barbanti M, Mule M, Pistritto AM, Aruta P, Cammalleri V, Scarabelli M, Mangiafico S, Scandura S, Ussia GP. Reduction of mitral valve regurgitation with Mitraclip(R) percutaneous system. Minerva Cardioangiol. 2010 Oct;58(5):589-98.
PubMed 20948505
Lim DS, Kunjummen BJ, Smalling R. Mitral valve repair with the MitraClip device after prior surgical mitral annuloplasty. Catheter Cardiovasc Interv. 2010 Sep 1;76(3):455-9. doi: 10.1002/ccd.22547.
PubMed 20839359
Tamburino C, Ussia GP, Maisano F, Capodanno D, La Canna G, Scandura S, Colombo A, Giacomini A, Michev I, Mangiafico S, Cammalleri V, Barbanti M, Alfieri O. Percutaneous mitral valve repair with the MitraClip system: acute results from a real world setting. Eur Heart J. 2010 Jun;31(11):1382-9. doi: 10.1093/eurheartj/ehq051. Epub 2010 Mar 18.
PubMed 20299349
Argenziano M, Skipper E, Heimansohn D, Letsou GV, Woo YJ, Kron I, Alexander J, Cleveland J, Kong B, Davidson M, Vassiliades T, Krieger K, Sako E, Tibi P, Galloway A, Foster E, Feldman T, Glower D; EVEREST Investigators. Surgical revision after percutaneous mitral repair with the MitraClip device. Ann Thorac Surg. 2010 Jan;89(1):72-80; discussion p 80. doi: 10.1016/j.athoracsur.2009.08.063.
PubMed 20103209
Rogers JH, Yeo KK, Carroll JD, Cleveland J, Reece TB, Gillinov AM, Rodriguez L, Whitlow P, Woo YJ, Herrmann HC, Young JN. Late surgical mitral valve repair after percutaneous repair with the MitraClip system. J Card Surg. 2009 Nov-Dec;24(6):677-81. doi: 10.1111/j.1540-8191.2009.00901.x. Epub 2009 Jul 24.
PubMed 19682161
Feldman T, Kar S, Rinaldi M, Fail P, Hermiller J, Smalling R, Whitlow PL, Gray W, Low R, Herrmann HC, Lim S, Foster E, Glower D; EVEREST Investigators. Percutaneous mitral repair with the MitraClip system: safety and midterm durability in the initial EVEREST (Endovascular Valve Edge-to-Edge REpair Study) cohort. J Am Coll Cardiol. 2009 Aug 18;54(8):686-94. doi: 10.1016/j.jacc.2009.03.077.
PubMed 19679246
Herrmann HC, Kar S, Siegel R, Fail P, Loghin C, Lim S, Hahn R, Rogers JH, Bommer WJ, Wang A, Berke A, Lerakis S, Kramer P, Wong SC, Foster E, Glower D, Feldman T; EVEREST Investigators. Effect of percutaneous mitral repair with the MitraClip device on mitral valve area and gradient. EuroIntervention. 2009 Jan;4(4):437-42. doi: 10.4244/eijv4i4a76.
PubMed 19284064
Luk A, Butany J, Ahn E, Fann JI, St Goar F, Thornton T, McDermott L, Madayag C, Komtebedde J. Mitral repair with the Evalve MitraClip device: histopathologic findings in the porcine model. Cardiovasc Pathol. 2009 Sep-Oct;18(5):279-85. doi: 10.1016/j.carpath.2008.07.001. Epub 2008 Aug 13.
PubMed 18703359
Pope NH, Lim S, Ailawadi G. Late calcific mitral stenosis after MitraClip procedure in a dialysis-dependent patient. Ann Thorac Surg. 2013 May;95(5):e113-4. doi: 10.1016/j.athoracsur.2012.10.067.
PubMed 23608290
Cikirikcioglu M, Cherian S, Schussler O, Kalangos A. Regarding "The EVEREST II Trial: design and rationale for a randomized study of the Evalve MitraClip system compared with mitral valve surgery for mitral regurgitation". Am Heart J. 2011 Jul;162(1):e11-2; author reply e13. doi: 10.1016/j.ahj.2011.04.004. Epub 2011 Jun 12. No abstract available.
PubMed 21742074
Condado JA, Velez-Gimon M. Catheter-based approach to mitral regurgitation. J Interv Cardiol. 2003 Dec;16(6):523-34. doi: 10.1046/j.1540-8183.2003.01052.x.
PubMed 14632950
Fann JI, St Goar FG. Percutaneous aortic valve replacement and mitral valve repair. Future Cardiol. 2005 May;1(3):393-403. doi: 10.1517/14796678.1.3.393.
PubMed 19804122

Want to know more?

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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

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Mitral Valve Insufficiency
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Heart Failure - NYHA II - IV, Mitral Regurgitation Functional
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Mitral Regurgitation (MR)

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: Pivotal Study: A Study of the Evalve Cardiovascular Valve Repair System - Endovascular Valve Edge-to-Edge REpair STudy (EVERESTIIRCT)
ClinicalTrials.gov ID: NCT00209274
Acronym / sponsor ID: EVERESTIIRCT / Protocol #0401
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: 279 participants (actual)
Lead sponsor: Abbott Medical DevicesIndustry (pharma, biotech, devices)
Study start: Aug 2005
Primary completion: Nov 2009 (actual)
Study completion: Dec 2014 (actual)
First posted: 21 Sep 2005 (estimated)
Results: Posted 5 Sep 2017

Clinical summary

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

Detailed description

38 clinical sites throughout the US and Canada have participated in the RCT and HRR. 37 US sites are participating in REALISM.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
1	Experimental	Device: Percutaneous mitral valve repair using MitraClip implantPercutaneous mitral valve repair using MitraClip implant. The calculated sample size was 186 patients in the device arm
2	Active comparator	Procedure: Mitral valve repair or replacement surgeryMitral valve repair or replacement surgery. The calculated sample size was 93 patients in the control arm.

Who may qualify

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

Key inclusion criteria (13 listed)

Patients with Grade 3 (moderate to severe) or Grade 4 (severe) mitral regurgitation (MR) based on American Society of Echocardiography guidelines:
Are 18 years or older.
Symptomatic
If asymptomatic, must have new onset of atrial fibrillation, pulmonary hypertension, or evidence of left ventricular dysfunction
Are candidates for mitral valve surgery

Key exclusion criteria (0 listed)

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: MitraClipMitraClip Implant	Device	1
Mitral valve repair or replacement surgeryRepair or replacement of mitral valve	Procedure or surgery	2

Primary outcome

Number of Participants With Major Adverse Events (MAE)
Time frame: 30 days
Defined as a 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, gastrointestinal (GI) complication requiring surgery, new onset of permanent atrial fibrillation, septicemia, and transfusion of 2 or more units of blood.
Number of Participants With Freedom From Surgery for Valve Dysfunction, Death, and Moderate to Severe (3+) or Severe (4+) Mitral Regurgitation (MR).
Time frame: 12 months

155 secondary outcomes

Freedom From All-Cause Mortality
Time frame: 12 months
Freedom From All-Cause Mortality
Time frame: 24 months
Freedom From All-Cause Mortality
Time frame: 3 years
Freedom From All-Cause Mortality
Time frame: 4 years
Freedom From All-Cause Mortality
Time frame: 5 years
Number of Participants With Freedom From Surgery for Valve Dysfunction, Death, and Moderate to Severe (3+) or Severe (4+) Mitral Regurgitation.
Time frame: 12 months
Number of Participants With Freedom From Surgery for Valve Dysfunction, Death, and Moderate to Severe (3+) or Severe (4+) Mitral Regurgitation (MR).
Time frame: 24 months
Number of Participants With Freedom From Surgery for Valve Dysfunction, Death, and Moderate to Severe (3+) or Severe (4+) Mitral Regurgitation (MR) in Intention to Treat Strategy Cohort
Time frame: 24 months
Left Ventricular Ejection Fraction (LVEF)
Time frame: At discharge (≤ 14 days following index procedure) or 30 days
Left Ventricular Ejection Fraction (LVEF)
Time frame: 12 months
Left Ventricular Ejection Fraction (LVEF)
Time frame: 24 months
Left Ventricular Ejection Fraction (LVEF)
Time frame: 3 years
Left Ventricular Ejection Fraction (LVEF)
Time frame: 4 years
Left Ventricular Ejection Fraction (LVEF)
Time frame: 5 years
Left Ventricular Status- Left Ventricular End-diastolic Volume (LVEDV), Left Ventricular End-systolic Volume (LVESV)
Time frame: 30 days
Left Ventricular Status- LVEDV, LVESV
Time frame: 12 months
Left Ventricular Status- LVEDV, LVESV
Time frame: 24 months
Left Ventricular Status- LVEDV, LVESV
Time frame: 3 years
Left Ventricular Status- LVEDV, LVESV
Time frame: 4 years
Left Ventricular Status- LVEDV, LVESV
Time frame: 5 years
Left Ventricular Internal Dimension Systole (LVIDs)
Time frame: 30 days
Left Ventricular Internal Dimension Systole (LVIDs)
Time frame: 12 months
Left Ventricular Internal Dimension Systole (LVIDs)
Time frame: 2 years
Left Ventricular Internal Dimension Systole (LVIDs)
Time frame: 3 years
Left Ventricular Internal Dimension Systole (LVIDs)
Time frame: 4 years
Left Ventricular Internal Dimension Systole (LVIDs)
Time frame: 5 years
Left Ventricular Internal Dimension Diastole (LVIDd)
Time frame: 30 days
Left Ventricular Internal Dimension Diastole (LVIDd)
Time frame: 12 months
Left Ventricular Internal Dimension Diastole (LVIDd)
Time frame: 24 months
Left Ventricular Internal Dimension Diastole (LVIDd)
Time frame: 3 years
Left Ventricular Internal Dimension Diastole (LVIDd)
Time frame: 4 years
Left Ventricular Internal Dimension Diastole (LVIDd)
Time frame: 5 years
Number of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease.
Time frame: Baseline
Number of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease.
Time frame: 30 days
Number of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease.
Time frame: 12 months
Number of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease.
Time frame: 24 months
Number of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease.
Time frame: 3 years
Number of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease.
Time frame: 4 years
Number of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease.
Time frame: 5 years
New York Heart Association (NYHA) Functional Class Cardiac Disease: NYHA Functional Class III or IV
Time frame: 30 days

Results and safety

Results posted to the registry on 5 Sep 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
Device Group (MitraClip Device)	184	113
Control Group (Mitral Valve Surgery)	95	48

Primary outcome: Number of Participants With Major Adverse Events (MAE)

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

Measure	Device Group (MitraClip Device) n = 136	Control Group (Mitral Valve Surgery) n = 79
Value	13	45

Population analysed: Per-protocol cohort. The number of participants analyzed includes subjects who had available follow up data at that time frame.

Primary outcome: Number of Participants With Freedom From Surgery for Valve Dysfunction, Death, and Moderate to Severe (3+) or Severe (4+) Mitral Regurgitation (MR).

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

Measure	Device Group (MitraClip Device) n = 134	Control Group (Mitral Valve Surgery) n = 74
Value	97	65

Population analysed: Per-protocol cohort. The number of participants analyzed includes subjects who had available follow up data at that time frame.

155 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
Device Group (MitraClip Device)	127 of 178 (71.3%)	168 of 178 (94.4%)	20 of 178
Control Group (Mitral Valve Surgery)	54 of 80 (67.5%)	80 of 80 (100%)	9 of 80

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.
Background: PubMed 15302782Fann JI, St Goar FG, Komtebedde J, Oz MC, Block PC, Foster E, Butany J, Feldman T, Burdon TA. Beating heart catheter-based edge-to-edge mitral valve procedure in a porcine model: efficacy and healing response. Circulation. 2004 Aug 24;110(8):988-93. doi: 10.1161/01.CIR.0000139855.12616.15. Epub 2004 Aug 9.
Background: PubMed 14530193St Goar FG, Fann JI, Komtebedde J, Foster E, Oz MC, Fogarty TJ, Feldman T, Block PC. Endovascular edge-to-edge mitral valve repair: short-term results in a porcine model. Circulation. 2003 Oct 21;108(16):1990-3. doi: 10.1161/01.CIR.0000096052.78331.CA. Epub 2003 Oct 6.
Background: PubMed 21036802Borgia F, Di Mario C, Franzen O. Adenosine-induced asystole to facilitate MitraClip placement in a patient with adverse mitral valve morphology. Heart. 2011 May;97(10):864. doi: 10.1136/hrt.2010.208132. Epub 2010 Oct 29. No abstract available.
Background: PubMed 20948505Tamburino C, Imme S, Barbanti M, Mule M, Pistritto AM, Aruta P, Cammalleri V, Scarabelli M, Mangiafico S, Scandura S, Ussia GP. Reduction of mitral valve regurgitation with Mitraclip(R) percutaneous system. Minerva Cardioangiol. 2010 Oct;58(5):589-98.
Background: PubMed 20839359Lim DS, Kunjummen BJ, Smalling R. Mitral valve repair with the MitraClip device after prior surgical mitral annuloplasty. Catheter Cardiovasc Interv. 2010 Sep 1;76(3):455-9. doi: 10.1002/ccd.22547.
Background: PubMed 20299349Tamburino C, Ussia GP, Maisano F, Capodanno D, La Canna G, Scandura S, Colombo A, Giacomini A, Michev I, Mangiafico S, Cammalleri V, Barbanti M, Alfieri O. Percutaneous mitral valve repair with the MitraClip system: acute results from a real world setting. Eur Heart J. 2010 Jun;31(11):1382-9. doi: 10.1093/eurheartj/ehq051. Epub 2010 Mar 18.
Background: PubMed 20103209Argenziano M, Skipper E, Heimansohn D, Letsou GV, Woo YJ, Kron I, Alexander J, Cleveland J, Kong B, Davidson M, Vassiliades T, Krieger K, Sako E, Tibi P, Galloway A, Foster E, Feldman T, Glower D; EVEREST Investigators. Surgical revision after percutaneous mitral repair with the MitraClip device. Ann Thorac Surg. 2010 Jan;89(1):72-80; discussion p 80. doi: 10.1016/j.athoracsur.2009.08.063.
Background: PubMed 19682161Rogers JH, Yeo KK, Carroll JD, Cleveland J, Reece TB, Gillinov AM, Rodriguez L, Whitlow P, Woo YJ, Herrmann HC, Young JN. Late surgical mitral valve repair after percutaneous repair with the MitraClip system. J Card Surg. 2009 Nov-Dec;24(6):677-81. doi: 10.1111/j.1540-8191.2009.00901.x. Epub 2009 Jul 24.
Background: PubMed 19679246Feldman T, Kar S, Rinaldi M, Fail P, Hermiller J, Smalling R, Whitlow PL, Gray W, Low R, Herrmann HC, Lim S, Foster E, Glower D; EVEREST Investigators. Percutaneous mitral repair with the MitraClip system: safety and midterm durability in the initial EVEREST (Endovascular Valve Edge-to-Edge REpair Study) cohort. J Am Coll Cardiol. 2009 Aug 18;54(8):686-94. doi: 10.1016/j.jacc.2009.03.077.
Background: PubMed 19284064Herrmann HC, Kar S, Siegel R, Fail P, Loghin C, Lim S, Hahn R, Rogers JH, Bommer WJ, Wang A, Berke A, Lerakis S, Kramer P, Wong SC, Foster E, Glower D, Feldman T; EVEREST Investigators. Effect of percutaneous mitral repair with the MitraClip device on mitral valve area and gradient. EuroIntervention. 2009 Jan;4(4):437-42. doi: 10.4244/eijv4i4a76.
Background: PubMed 18703359Luk A, Butany J, Ahn E, Fann JI, St Goar F, Thornton T, McDermott L, Madayag C, Komtebedde J. Mitral repair with the Evalve MitraClip device: histopathologic findings in the porcine model. Cardiovasc Pathol. 2009 Sep-Oct;18(5):279-85. doi: 10.1016/j.carpath.2008.07.001. Epub 2008 Aug 13.
Background: PubMed 23608290Pope NH, Lim S, Ailawadi G. Late calcific mitral stenosis after MitraClip procedure in a dialysis-dependent patient. Ann Thorac Surg. 2013 May;95(5):e113-4. doi: 10.1016/j.athoracsur.2012.10.067.

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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., MD principal investigator

Duke University Medical Center, Department of Surgery

1 site 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 13 inclusion and 0 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 1 site 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 5 Sep 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?

Number of Participants With Major Adverse Events (MAE) (time frame: 30 days). The study lists 2 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 NCT00209274, which also lists 39 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.