Evaluation of Outcomes of CRT and MitraClip for Treatment of Low Ejection Fraction and Functional Mitral Regurgitation in HF

Evaluation of Outcomes of Cardiac Resynchronization Therapy and MitraClip for the Treatment of Low Ejection Fraction and Functional Mitral Valve Regurgitation in Heart Failure

NCT02985268•Montreal Heart Institute

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Summary

At present, the optimal treatment strategy for heart failure patients and moderate-to-severe (3+) or severe (4+) mitral regurgitation with a class IIa recommendation for CRT is uncertain.Whether these patents should also be treated for functional mitral regurgitation or with CRT also remains unclear. We therefore propose a randomized 2x2 factorial design in this patient population to understand the the impact of both CRT and transcatheter mitral valve repair with the MitraClip on their functional status and quality of life.

Eligibility

Age

All ages

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Symptomatic moderate-to-severe (3+) or severe (4+) functional mitral regurgitation due to cardiomyopathy of either ischemic or non-ischemic etiology as determined by transthoracic echocardiogram (TTE), and confirmed by the Echocardiography Core Lab (ECL);
•2. Symptomatic heart failure as defined by New York Heart Association (NYHA) class II, III or ambulatory IV;
•3. Treatment and compliance with optimal medical therapy for heart failure for at least 30 days; Optimal medical therapy is defined by: Maximum tolerated beta-blocker, angiotensin converting enzyme inhibitor (ACE) or angiotensin receptor blocker (ARB), and aldosterone antagonist (as per the ACCF/AHA Guidelines as judged by the HF specialist investigator on site and confirmed by the Clinical Eligibility Committee).
•4. Left ventricular ejection fraction ≤ 35%, as assessed by any one of the following methods: echocardiography, contrast left ventriculography, gated blood pool scan or cardiac magnetic resonance imaging (MRI);
•5. Class IIa indication for cardiac resynchronization therapy:
•1. Left bundle branch block (LBBB) and QRS duration of 120-149 ms;
•2. Right bundle branch block (RBBB) and QRS ≥ 150 ms.
•6. Clinical agreement amongst local investigators that the patient will not be offered surgical intervention;
•7. The primary regurgitant jet, in the opinion of the MitraClip implanting investigator, can successfully be treated by the MitraClip. Treatment of commissural mitral regurgitation may be treated at the discretion of the operator. All major jets contributing the secondary MR will be treated with the MitraClip;
•8. Ability to perform a six-minute walk test (6MWT) without substantial physical limitations and without use of a walker or wheelchair and distance walked in 6 minutes of ≤ 450m;
+1 more criteria

Exclusion Criteria

•1. Life expectancy less than 12 months due to noncardiac conditions;
•2. ACC/AHA Stage D Heart Failure;
•3. Left ventricular ejection fraction ≤ 15%;
•4. Hypotension (systolic pressure \<90 mm Hg) or requirement for inotropic support or mechanical hemodynamic support;
•5. United Network for Organ Sharing (UNOS) status 1 heart transplantation or prior orthotopic heart transplantation;
•6. Untreated clinically significant coronary artery disease requiring revascularization;
•7. CABG within prior 30 days;
•8. Percutaneous coronary intervention within prior 30 days;
•9. Severe Chronic Obstructive Pulmonary Disease (COPD) requiring continuous daytime home oxygen or chronic oral corticosteroid therapy;
•10. Previous surgical mitral valve bioprosthesis, mitral annuloplasty, or transcatheter mitral valve procedure;
+24 more criteria

Key Dates

Start Date

December 1, 2016

Primary Completion Date

December 1, 2019

Completion Date

February 1, 2020

Last Updated

February 27, 2020

Conditions

Functional Mitral RegurgitationHeart Failure

Interventions

MitraClip

DEVICE

Optimal Medical Therapy

DRUG

CRT-D

DEVICE

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 27, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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View ClinicalTrials.gov Terms and Conditions

Evaluation of Outcomes of CRT and MitraClip for Treatment of Low Ejection Fraction and Functional Mitral Regurgitation in HF

Inclusion Criteria

Exclusion Criteria

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