Mitral Valve (MV) RegurgitationACCESS-EUNCT01288976
ACCESS-Europe A Two-Phase Observational Study of the MitraClip® System in Europe
An observational study of Mitral Valve (MV) Regurgitation, run by Abbott Medical Devices at 1 site in Germany.
Trial summary
The MitraClip System enables the European physicians an alternative therapeutic option for patients with mitral regurgitation (MR). Therapeutic alternatives are open-heart cardiac surgery, and palliative medical therapy with or without device therapy. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Mitral Valve (MV) Regurgitation
- What is being tested?
- MitraClip, Medical Management and Mitral Valve Surgery
- Type of treatment
- Medical device, Surgery or procedure
- How many people
- 721 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2008to Aug 2012
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with Mitral Regurgitation
Who may be able to join
- Per the current approved labeling for the Conformity European (CE) Marked MitraClip System.
Who cannot join
- Per the current approved labeling for the CE Marked MitraClip System.
Trial locations and contacts
1 site in 1 country.
About this study
The MitraClip System enables the European physicians an alternative therapeutic option for patients with mitral regurgitation (MR). Therapeutic alternatives are open-heart cardiac surgery, and palliative medical therapy with or without device therapy. The study will observe the outcomes of patients treated with the MitraClip System throughout 12-months as compared to the outcomes of patients treated by alternative therapies.
Read the detailed description
PHASE I:
The primary objective of ACCESS-EU Phase I is to gain information in the European Union Countries regarding the use of the MitraClip System with respect to health economics and clinical care.
PHASE II: (HAS BEEN CLOSED BY SPONSOR) The primary objective of ACCESS-EU Phase II is to gather additional clinical data, specifically Echocardiography Core Laboratory measurements of MR severity and left ventricular volumes and diameters, and other echocardiographic measures, on patients undergoing the MitraClip procedure in the European Union Countries,
Clinical data collected from both study phases, is expected to contribute to decision making with regards to MitraClip therapy selection in patients with MR: (a) by establishing the value of the MitraClip therapy in the continuum of care; and (b) by providing practical information that will allow physicians to make therapeutic decisions, assist hospitals to make purchasing decisions, and assist insurers in making coverage decisions.
Study Design:
ACCESS-Europe is a two-phase prospective, observational, multicenter post-approval study of the MitraClip System for the treatment of mitral regurgitation (MR) in the European Union Countries. Patients will be evaluated per standard practice at baseline, discharge, 6-Months and 12-Months.
Phase I of the study consists of patients who receive the MitraClip system for the treatment of MR and two concurrent comparator groups of (a) medically managed heart failure patients with MR and (b) patients who have undergone mitral valve surgery for MR. The two comparator groups will be followed and evaluated primarily from a health economic perspective.
ACCESS EU Study Phase II will consist of only patients who receive the MitraClip System, with the objective to collect additional clinical data, specifically Echocardiography Core Laboratory evaluation of MR severity and other echocardiographic measures.
Enrollment of patients in each study phase is as follows:
ACCESS-EU PHASE I:
- A minimum of 300 MitraClip Therapy group patients,
- A minimum of 100 patients in the Mitral Valve Surgery comparator group
- As many patients as possible in the Medical Therapy comparator group
First Patient Enrollment Projection: Q1, 2009 Last Patient Enrollment Projection: Enrollment in the Mitral Valve Surgery and Medically Therapy groups ceased on December 31, 2010. Enrollment in the MitraClip group will cease when Phase II of the study is initiated at each site.
ACCESS-EU PHASE II:
A minimum of 300 MitraClip therapy subjects will be enrolled in Phase II.
First Patient Enrollment Projection: Q2, 2011 Last Patient Enrollment Projection: Enrollment will cease when the Sponsor has determined that an adequate number of patients have been enrolled.
- Conditions
- Mitral Valve (MV) Regurgitation
- Being tested
- MitraClip, Medical Management, Mitral Valve Surgery
- Keywords
- Mitral Valve, Mitral Regurgitation, MitraClip, Mitral Valve Surgery, Mitral Valve Insufficiency or Mitral Regurgitation
- Medical subject headings
- Gastroesophageal Reflux, Mitral Valve Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MitraClipDevice
The MitraClip System includes a MitraClip device, a Steerable Guide Catheter, and a MitraClip Delivery System that enables placement of the MitraClip device on the mitral valve leaflets
Medical ManagementDrug
The Non-Surgical Medically Managed Heart Failure (HF) Group consists of patients with mitral regurgitation (MR) in whom the MR is managed non-surgically based on standard hospital clinical practice. Patients with MR who receive a pacemaker, Implantable Cardiac Defibrillator (ICD) and/or Cardiac Resynchronization Therapy (CRT) treatments may be included
Mitral Valve SurgeryProcedure or surgery
The Mitral Valve Surgery Group consists of patients with MR in whom the MR is managed surgically (repair or replacement) based on standard hospital clinical practice. Patients with concurrent coronary artery bypass grafting (CABG) or aortic/tricuspid valve or and other cardiac procedure except atrial fibrillation surgery are excluded.
| Study group | Role | What they receive |
|---|---|---|
| MitraClip Therapy | Patients treated with the MitraClip System. Receives: Device: MitraClip | |
| Medical Management | Patients with MR managed non-surgically based on standard hospital clinical practice. Receives: Drug: Medical Management | |
| Mitral Valve Surgery | Patients with MR managed surgically (repair or replacement) based on standard hospital clinical practice. Receives: Procedure: Mitral Valve Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
MR severity was not consistently captured for patients in the Medical Management and Mitral Valve Surgery groups. The Medical Therapy \& Mitral Valve Surgery comparator groups were followed \& studied primarily from a health economic perspective. Availability of clinical outcomes at followup is limited \& has not been validated. Clinical outcomes for the comparator groups will not be reported.
Measured: At baseline
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.
MR severity was not consistently captured for patients in the Medical Management and Mitral Valve Surgery groups. The Medical Therapy \& Mitral Valve Surgery comparator groups were followed \& studied primarily from a health economic perspective. Availability of clinical outcomes at follow-up is limited \& has not been validated. Clinical outcomes for the comparator groups will not be reported.
Measured: At 12 months
Secondary outcomes (20)
Procedure Time
Procedure Time is defined as the time of start of the transseptal procedure to the time the Steerable Guide Catheter is removed.
Measured: Day 0 (On the day of procedure)
Contrast Volume
Measured: Day 0 (On the day of procedure)
Fluoroscopy Duration
Measured: Day 0 (On the day of procedure)
Number of MitraClip Devices Implanted
Physicians had the option of deploying more than 1 MitraClip device if a single device did not provide satisfactory MR reduction, and if the mitral valve area was large enough to allow multiple MitraClip devices to be placed without causing mitral stenosis.
Measured: Day 0 (On the day of procedure)
ICU and Hospital Stay
ICU and hospital stay is defined as the mean duration of time that patients spent in the ICU (Intensive Care Unit)/ CCU (Cardiac Care Unit)/ PACU (Post-Anesthesia Care Unit) following the MitraClip procedure. This secondary outcome measure does not apply to the Medical Management or the Mitral Valve Surgery groups.
Measured: From the day of procedure throughout 12 months of study period
Discharge Status and Facility
Measured: At discharge, an average of 7.7 days following the MitraClip procedure
Discharge MR Severity
Measured: At discharge, an average of 7.7 days following the MitraClip procedure
Kaplan-Meier Freedom From All-Cause Mortality
Measured: At 0 day
Kaplan-Meier Freedom From All-Cause Mortality
Measured: At 30 days
Kaplan-Meier Freedom From All-Cause Mortality
Measured: At 6 months
Kaplan-Meier Freedom From All-Cause Mortality
Measured: At 12 months
Device Embolization and 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.
Single leaflet device attachment (SLDA) is defined as the loss of insertion of a single leaflet from the MitraClip device with ongoing insertion of the opposing leaflet. SLDAs are reported on ACCESS-EU adverse event log and MitraClip procedure electronic case report forms, and may also be reported by Abbott Vascular personnel per EU Vigilance requirements.
Measured: Through 12 months
1-Day Post-Procedure Safety Outcomes
This outcome measure does not apply to the Medical Management or the Mitral Valve Surgery groups. Because the Medical Therapy\&Mitral Valve Surgery comparator groups were followed\&studied primarily from a health economic perspective.Availability of clinical outcomes at follow-up is limited \& has not been validated. Clinical outcomes for the comparator groups will not be reported.
Measured: On day 1 post procedure
Need for Mitral Valve Surgery
This end point is assessed on subjects who underwent mitral valve surgery within 12 months post-MitraClip procedure.
Measured: Through 12 months
NYHA Functional Class
New York Heart Association (NYHA) Functional Classification.
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: At baseline
NYHA Functional Class
Defined as assessment of NYHA functional class status at follow-up compared to baseline NYHA functional class status.
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/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/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: At 12 month
The Change in 6 Minute Walk Test Distance From Baseline to 12 Months
The 6 minute walk distance test will be used to measure the patient's exercise capacity. The change in 6 minute walk test distance is calculated as the difference between the distance walked at 12 months and the distanced walked at baseline.
Measured: Baseline and 12 months
Change in Minnesota Living With Heart Failure (MLWHF) Quality of Life Score From Baseline to 12 Months
The Minnesota Living with Heart Failure Questionnaire(MLHFQ) is comprised of 21 questions.The response for each question ranges from 0(no affect on the patient's living) to 5(affected the patient's life very much during the past month).The total score for the 21 items can range from 0-105.A lower\&higher MLHFQ score indicates less effect of heart failure\&the worse impact of heart failure on a patient's QOL,respectively.Although the MLHFQ incorporates relevant aspects of the key dimensions of QOL (physical and emotional),the questionnaire was not designed to measure any particular dimension separately.The total score should be taken as the best measure of how heart failure and treatments impact QOL.
The total score is the sum of a)the physical dimension,measured using 8 questions (possible subscale score range 0-40) b)the emotional dimension,measured using 5 questions(possible subscale score from 0-25)\&c) other factors,measured using 8 questions (possible subscale score from 0-40).
Measured: 12 months
Six Minute Walk Test Distance (6MWT)
The 6-minute walk distance test will be used to measure the patient's exercise capacity.
Measured: Baseline
Six Minute Walk Test Distance (6MWT)
The 6-minute walk distance test will be used to measure the patient's exercise capacity.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2011 (estimated)
- Study startOct 2008
- Primary completionJun 2012
- Study completionAug 2012
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 (21)Papers the sponsor has linked to this study.
- Other trials for Mitral Valve (MV) RegurgitationStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 721 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Barathi Sethuraman, PhD, Study director, Abbott Vascular Structural Heart (Evalve Inc)Wolfgang Schillinger, MD, Principal investigator, Universitatsmedizin GottingenFrancesco Maisano, MD, Principal investigator, Fondazion Ctr San Raffaele Del Monte Tabor Istituto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01288976
- Sponsor's protocol ID
- EU-0901
- Acronym
- ACCESS-EU
- Status last verified
- Nov 2018
- First submitted
- 25 Jan 2011
- Last updated
- 7 Nov 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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 19682161Feldman 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 19679246Herrmann 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 19284064Luk 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 18703359Silvestry FE, Rodriguez LL, Herrmann HC, Rohatgi S, Weiss SJ, Stewart WJ, Homma S, Goyal N, Pulerwitz T, Zunamon A, Hamilton A, Merlino J, Martin R, Krabill K, Block PC, Whitlow P, Tuzcu EM, Kapadia S, Gray WA, Reisman M, Wasserman H, Schwartz A, Foster E, Feldman T, Wiegers SE. Echocardiographic guidance and assessment of percutaneous repair for mitral regurgitation with the Evalve MitraClip: lessons learned from EVEREST I. J Am Soc Echocardiogr. 2007 Oct;20(10):1131-40. doi: 10.1016/j.echo.2007.02.003. Epub 2007 Jun 13.
PubMed 17570634Borgia 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 21036802Tamburino 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 20948505Ciobanu A, Bennett S, Azam M, Clark A, Vinereanu D. Incremental value of three-dimensional transoesophageal echocardiography for guiding double percutaneous MitraClip (R) implantation in a 'no option' patient. Eur J Echocardiogr. 2011 Feb;12(2):E11. doi: 10.1093/ejechocard/jeq118. Epub 2010 Sep 27.
PubMed 20876188Lim 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 20839359Kalarus Z, Kukulski T, Lekston A, Streb W, Sikora J, Nadziakiewicz P, Gasior M, Polonski L, Zembala M. [Methodology and safety of transvascular reduction of severe ischaemic mitral insufficiency with MitraClip in high-surgical-risk patients - first three cases in Poland]. Kardiol Pol. 2010 Jun;68(6):729-35. Polish.
PubMed 20806217Geidel S, Ostermeyer J, Lass M, Schmoeckel M. Complex surgical valve repair after failed percutaneous mitral intervention using the MitraClip device. Ann Thorac Surg. 2010 Jul;90(1):277-9. doi: 10.1016/j.athoracsur.2009.12.048.
PubMed 20609795Mauri L, Garg P, Massaro JM, Foster E, Glower D, Mehoudar P, Powell F, Komtebedde J, McDermott E, Feldman T. 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. 2010 Jul;160(1):23-9. doi: 10.1016/j.ahj.2010.04.009.
PubMed 20598968Jonsson A, Settergren M. MitraClip catheter-based mitral valve repair system. Expert Rev Med Devices. 2010 Jul;7(4):439-47. doi: 10.1586/erd.10.23.
PubMed 20583881Ussia GP, Barbanti M, Tamburino C. Feasibility of percutaneous transcatheter mitral valve repair with the MitraClip system using conscious sedation. Catheter Cardiovasc Interv. 2010 Jun 1;75(7):1137-40. doi: 10.1002/ccd.22415.
PubMed 20336809Tamburino 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
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
- ACCESS-Europe A Two-Phase Observational Study of the MitraClip® System in Europe
- ClinicalTrials.gov ID
- NCT01288976
- Acronym / sponsor ID
- ACCESS-EU / EU-0901
- Conditions
- Mitral Valve (MV) Regurgitation
- Keywords
- Mitral Valve, Mitral Regurgitation, MitraClip, Mitral Valve Surgery, Mitral Valve Insufficiency or Mitral Regurgitation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 721 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- Oct 2008
- Primary completion
- Jun 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 3 Feb 2011 (estimated)
- Results
- Posted 18 Dec 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The MitraClip System enables the European physicians an alternative therapeutic option for patients with mitral regurgitation (MR). Therapeutic alternatives are open-heart cardiac surgery, and palliative medical therapy with or without device therapy. The study will observe the outcomes of patients treated with the MitraClip System throughout 12-months as compared to the outcomes of patients treated by alternative therapies.
Detailed description
PHASE I:
The primary objective of ACCESS-EU Phase I is to gain information in the European Union Countries regarding the use of the MitraClip System with respect to health economics and clinical care.
PHASE II: (HAS BEEN CLOSED BY SPONSOR) The primary objective of ACCESS-EU Phase II is to gather additional clinical data, specifically Echocardiography Core Laboratory measurements of MR severity and left ventricular volumes and diameters, and other echocardiographic measures, on patients undergoing the MitraClip procedure in the European Union Countries,
Clinical data collected from both study phases, is expected to contribute to decision making with regards to MitraClip therapy selection in patients with MR: (a) by establishing the value of the MitraClip therapy in the continuum of care; and (b) by providing practical information that will allow physicians to make therapeutic decisions, assist hospitals to make purchasing decisions, and assist insurers in making coverage decisions.
Study Design:
ACCESS-Europe is a two-phase prospective, observational, multicenter post-approval study of the MitraClip System for the treatment of mitral regurgitation (MR) in the European Union Countries. Patients will be evaluated per standard practice at baseline, discharge, 6-Months and 12-Months.
Phase I of the study consists of patients who receive the MitraClip system for the treatment of MR and two concurrent comparator groups of (a) medically managed heart failure patients with MR and (b) patients who have undergone mitral valve surgery for MR. The two comparator groups will be followed and evaluated primarily from a health economic perspective.
ACCESS EU Study Phase II will consist of only patients who receive the MitraClip System, with the objective to collect additional clinical data, specifically Echocardiography Core Laboratory evaluation of MR severity and other echocardiographic measures.
Enrollment of patients in each study phase is as follows:
ACCESS-EU PHASE I:
- A minimum of 300 MitraClip Therapy group patients,
- A minimum of 100 patients in the Mitral Valve Surgery comparator group
- As many patients as possible in the Medical Therapy comparator group
First Patient Enrollment Projection: Q1, 2009 Last Patient Enrollment Projection: Enrollment in the Mitral Valve Surgery and Medically Therapy groups ceased on December 31, 2010. Enrollment in the MitraClip group will cease when Phase II of the study is initiated at each site.
ACCESS-EU PHASE II:
A minimum of 300 MitraClip therapy subjects will be enrolled in Phase II.
First Patient Enrollment Projection: Q2, 2011 Last Patient Enrollment Projection: Enrollment will cease when the Sponsor has determined that an adequate number of patients have been enrolled.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| MitraClip Therapy | – | Device: MitraClipPatients treated with the MitraClip System. |
| Medical Management | – | Drug: Medical ManagementPatients with MR managed non-surgically based on standard hospital clinical practice. |
| Mitral Valve Surgery | – | Procedure: Mitral Valve SurgeryPatients with MR managed surgically (repair or replacement) based on standard hospital clinical practice. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with Mitral Regurgitation
Key inclusion criteria (1 listed)
- Per the current approved labeling for the Conformity European (CE) Marked MitraClip System.
Key exclusion criteria (1 listed)
- Per the current approved labeling for the CE Marked MitraClip System.
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 |
|---|---|---|
| MitraClipThe MitraClip System includes a MitraClip device, a Steerable Guide Catheter, and a MitraClip Delivery System that enables placement of the MitraClip device on the mitral valve leaflets | Device | MitraClip Therapy |
| Medical ManagementThe Non-Surgical Medically Managed Heart Failure (HF) Group consists of patients with mitral regurgitation (MR) in whom the MR is managed non-surgically based on standard hospital clinical practice. Patients with MR who receive a pacemaker, Implantable Cardiac Defibrillator (ICD) and/or Cardiac Resynchronization Therapy (CRT) treatments may be included | Drug | Medical Management |
| Mitral Valve SurgeryThe Mitral Valve Surgery Group consists of patients with MR in whom the MR is managed surgically (repair or replacement) based on standard hospital clinical practice. Patients with concurrent coronary artery bypass grafting (CABG) or aortic/tricuspid valve or and other cardiac procedure except atrial fibrillation surgery are excluded. | Procedure or surgery | Mitral Valve Surgery |
Primary outcome
MR Severity
Time frame: At baseline
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. MR severity was not consistently captured for patients in the Medical Management and Mitral Valve Surgery groups. The Medical Therapy \& Mitral Valve Surgery comparator groups were followed \& studied primarily from a health economic perspective. Availability of clinical outcomes at followup is limited \& has not been validated. Clinical outcomes for the comparator groups will not be reported.
MR Severity
Time frame: At 12 months
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. MR severity was not consistently captured for patients in the Medical Management and Mitral Valve Surgery groups. The Medical Therapy \& Mitral Valve Surgery comparator groups were followed \& studied primarily from a health economic perspective. Availability of clinical outcomes at follow-up is limited \& has not been validated. Clinical outcomes for the comparator groups will not be reported.
20 secondary outcomes
Procedure Time
Time frame: Day 0 (On the day of procedure)
Contrast Volume
Time frame: Day 0 (On the day of procedure)
Fluoroscopy Duration
Time frame: Day 0 (On the day of procedure)
Number of MitraClip Devices Implanted
Time frame: Day 0 (On the day of procedure)
ICU and Hospital Stay
Time frame: From the day of procedure throughout 12 months of study period
Discharge Status and Facility
Time frame: At discharge, an average of 7.7 days following the MitraClip procedure
Discharge MR Severity
Time frame: At discharge, an average of 7.7 days following the MitraClip procedure
Kaplan-Meier Freedom From All-Cause Mortality
Time frame: At 0 day
Kaplan-Meier Freedom From All-Cause Mortality
Time frame: At 30 days
Kaplan-Meier Freedom From All-Cause Mortality
Time frame: At 6 months
Kaplan-Meier Freedom From All-Cause Mortality
Time frame: At 12 months
Device Embolization and Single Leaflet Device Attachment
Time frame: Through 12 months
1-Day Post-Procedure Safety Outcomes
Time frame: On day 1 post procedure
Need for Mitral Valve Surgery
Time frame: Through 12 months
NYHA Functional Class
Time frame: At baseline
NYHA Functional Class
Time frame: At 12 month
The Change in 6 Minute Walk Test Distance From Baseline to 12 Months
Time frame: Baseline and 12 months
Change in Minnesota Living With Heart Failure (MLWHF) Quality of Life Score From Baseline to 12 Months
Time frame: 12 months
Six Minute Walk Test Distance (6MWT)
Time frame: Baseline
Six Minute Walk Test Distance (6MWT)
Time frame: 12 months
Results and safety
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 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.
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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.
Barathi Sethuraman, PhD study director
Abbott Vascular Structural Heart (Evalve Inc)
Wolfgang Schillinger, MD principal investigator
Universitatsmedizin Gottingen
Francesco Maisano, MD principal investigator
Fondazion Ctr San Raffaele Del Monte Tabor Istituto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mitral Valve (MV) Regurgitation, run by Abbott Medical Devices at 1 site in Germany.
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 1 inclusion and 1 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 Germany. 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 18 Dec 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?
MR Severity (time frame: At baseline). 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 NCT01288976, which also lists 21 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.