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

Study Overview
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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.

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.

Official Title
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EValuation of Outcomes of Transcatheter Mitral Valve Repair for the Treatment of Low Ejection Fraction and Moderate Functional Mitral ValvE Regurgitation In Heart Failure

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

Intervention / Treatment
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* Device: Transcatheter mitral valve repair
* Other: Guideline-directed medical therapy


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patients will be randomized 1:1 to medical treatment or intervention with the MitraClip device
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Guideline-directed medical therapy<br>Standard guideline-directed medical treatment for heart failure | Other: Guideline-directed medical therapy<br>* Standard medical therapy for heart failure as recommended by HF guidelines<br>|
| Experimental: Transcatheter Mitral valve repair<br>MitraClip treatment | Device: Transcatheter mitral valve repair<br>* Transcatheter mitral valve repair performed using the MitraClip device<br>* Other names: MitraClip;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Left ventricular diastolic remodelling | Change in indexed left ventricular diastolic volume (LVEDV) | 12 months | 
| Functional capacity as measured by 6 minute walk test | Change in distance walked on six-minute walk test | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mitral regurgitation Severity (RV) | Change in mitral regurgitant volume | 12 months | 
| Mitral regurgitation Severity (EROA) | Change in effective regurgitant orifice area | 12 months | 
| Quality of Life Measurement | Change in indices of quality of life as measured by Kansas City Cardiomyopathy Questionnaire. The Kansas City Cardiomyopathy Questionnaire is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. In the KCCQ, an overall summary score can be derived from the physical function, symptom (frequency and severity), social function and quality of life domains. For each domain, the validity, reproducibility, responsiveness and interpretability have been independently established. Scores are transformed to a range of 0-100, in which higher scores reflect better health status. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mitral regurgitation, transcatheter mitral valve repair