MitraClip for the Treatment of Moderate Functional Mitral Regurgitation: EVOLVE-MR

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

174 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-22

Study Completion Date

2022-01-31

Brief Summary

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This study evaluates the addition of transcatheter mitral valve repair with the MitraClip device to medical treatment in patients with heart failure and moderate functional mitral regurgitation to determine the impact of left ventricular remodelling and patients' functional capacity.

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Detailed Description

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Moderate mitral regurgitation in patients with LV dysfunction is associated with increased risk of death and hospitalizations for heart failure (HF) and leads to progressive remodelling of an already damaged left ventricle. Medical therapies and cardiac resynchronization therapy (CRT) have demonstrated favourable effects on LV remodelling in heart failure patients.

Given the benefits and safety of transcatheter mitral valve repair with the MitraClip device in severe MR, it is conceivable that this technology could also be safely used in those with moderate MR to reduce mitral regurgitation, improve symptoms and result in LV remodelling. At present, the optimal treatment strategy for heart failure patients and moderate (2+, 2-3+) mitral regurgitation is uncertain therefore the EVOLVE-MR study proposes to evaluate transcatheter mitral valve repair with the MitraClip in such patients to study the effects on LV remodelling and functional capacity.

EVOLVE-MR is a randomized study of MitraClip and medical therapy in symptomatic heart failure patients with moderate (2+, 2-3+) secondary mitral regurgitation. The objective of this study is to determine the impact of both therapies on left ventricular remodelling and functional capacity of the target patient population.

Conditions

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Mitral Regurgitation Heart Failure Mitral Valve Regurgitation Due to Cardiomyopathy (Disorder)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Patients will be randomized 1:1 to medical treatment or intervention with the MitraClip device

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Guideline-directed medical therapy

Standard guideline-directed medical treatment for heart failure

Group Type PLACEBO_COMPARATOR

Guideline-directed medical therapy

Intervention Type OTHER

Standard medical therapy for heart failure as recommended by HF guidelines

Transcatheter Mitral valve repair

MitraClip treatment

Group Type EXPERIMENTAL

Transcatheter mitral valve repair

Intervention Type DEVICE

Transcatheter mitral valve repair performed using the MitraClip device

Interventions

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Transcatheter mitral valve repair

Transcatheter mitral valve repair performed using the MitraClip device

Intervention Type DEVICE

Guideline-directed medical therapy

Standard medical therapy for heart failure as recommended by HF guidelines

Intervention Type OTHER

Other Intervention Names

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MitraClip

Eligibility Criteria

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Inclusion Criteria

* Moderate functional mitral regurgitation (2+, 2-3+)
* Left ventricular ejection fraction \>20%
* LVEDV 75-110 ml/m2
* Symptomatic heart failure (NYHA Class II-IV)

Exclusion Criteria

* Left ventricular ejection fraction \< 20%
* Severe functional mitral regurgitation
* Recent coronary artery bypass graft surgery (CABG)
* Untreated significant coronary artery disease
* Mitral valve area \< 4.0cm2
* Severe pulmonary hypertension

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No