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

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

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.

Study Overview

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

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 Type: Interventional
• Enrollment (Anticipated): 174
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montréal, Quebec, Canada, H1T1C8
      • Recruiting
      • Montreal Heart Institute
      • Contact: Anita W Asgar, MD; Phone Number: 5143763330; Email: anita.asgar@umontreal.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Montreal Heart Institute
• Collaborators: Abbott Medical Devices
• Investigators: Principal Investigator: Anique Ducharme, MD, Montreal Heart Institute; Principal Investigator: Anita W Asgar, MD, Montreal Heart Institute; Study Chair: Jean L Rouleau, MD, Montreal Heart Institute

Study record dates

Study Major Dates

• Study Start (Actual): February 22, 2019
• Primary Completion (Anticipated): December 1, 2021
• Study Completion (Anticipated): January 1, 2022

Study Registration Dates

• First Submitted: August 4, 2018
• First Submitted That Met QC Criteria: October 11, 2018
• First Posted (Actual): October 15, 2018

Study Record Updates

• Last Update Posted (Actual): August 14, 2019
• Last Update Submitted That Met QC Criteria: August 12, 2019
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: mitral regurgitation; transcatheter mitral valve repair
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Valve Diseases; Heart Failure; Mitral Valve Insufficiency; Cardiomyopathies
• Other Study ID Numbers: 2019-2458

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes