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

Not Applicable

• Conditions: Mitral Valve Regurgitation Due to Cardiomyopathy (Disorder); Mitral Regurgitation; Heart Failure
• Interventions: Other: Guideline-directed medical therapy; Device: Transcatheter mitral valve repair

• Registration Number: NCT03705312
• Lead Sponsor: Montreal Heart Institute

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2018-08-04
• Status Verified: 2018-10
• Study First Submitted QC: 2018-10-11
• Study First Posted: 2018-10-15
• Study Start: 2019-02-22
• Last Update Submitted: 2019-08-12
• Last Update Posted: 2019-08-14
• Primary Completion: 2021-12
• Study Completion: 2022-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 174

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Guideline-directed medical therapy	Guideline-directed medical therapy	Standard guideline-directed medical treatment for heart failure
Transcatheter Mitral valve repair	Transcatheter mitral valve repair	MitraClip treatment

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Quality of Life Measurement	12 months	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.
Mitral regurgitation Severity (EROA)	12 months	Change in effective regurgitant orifice area
Mitral regurgitation Severity (RV)	12 months	Change in mitral regurgitant volume

Trial Locations

Locations (1)

Montreal Heart Institute; 🇨🇦 Montréal, Quebec, Canada