Transcatheter Mitral Valve Repair for the Treatment of Mitral Valve Regurgitation In Heart Failure (The EVOLVE-MR Trial)

Not Applicable

Terminated

• Conditions: Ventricular Remodeling, Left
• Interventions: Device: MitraClip; Drug: Medical Therapy

• Registration Number: NCT03891823
• Lead Sponsor: Montreal Heart Institute

Brief Summary

The study compares the effectiveness of treatment with MitraClip to medical therapy in improving the reduction of cardiovascular morbidity and functional capacity at 24 months, in patients with moderate functional mitral regurgitation.

Detailed Description

Primary Objective To compare the effectiveness of treatment with MitraClip to medical therapy on the change from baseline to 24 months in quality of life as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ) overall summary score in patients with moderate functional mitral regurgitation.

Secondary Objectives

* To evaluate the effects of MitraClip and medical therapy on change from baseline in mitral regurgitation severity at 24 months.

* To evaluate the effects of MitraClip and medical therapy on change from baseline in mitral regurgitation severity at 12 months.

* To evaluate the effects of MitraClip and medical therapy on change in quality of life from baseline to 12 months, as measured by the KCCQ.

Tertiary Objectives

* To evaluate the effects of MitraClip and medical therapy on change from baseline in functional capacity (distance walked on a 6MWT) at 12 and 24 Months.

* To evaluate the effects of MitraClip and medical therapy on change from baseline in quality of life, as measured by the EQ5DL questionnaire, at 12 and 24 months.

* To evaluate the effects of MitraClip and medical therapy on freedom from progression to severe MR at 24 months as assessed by echocardiography.

* To evaluate the effects of MitraClip and medical therapy on change from baseline in LVEDVi at 24 months.

Exploratory Objectives

* To evaluate the effects of MitraClip and medical therapy on functional class, biomarkers, clinical events, parameters of physical activity, other echocardiographic parameters and health economic assessments.

* To evaluate the effects of MitraClip and medical therapy on all hospitalizations for decompensated heart failure, including episodes of outpatient treatment intensification in a HF clinic or emergency department visits, at 24 months.

Study Timeline

• Study Start: 2019-03-08
• Study First Submitted: 2019-03-25
• Study First Submitted QC: 2019-03-25
• Study First Posted: 2019-03-27
• Primary Completion: 2024-03-28
• Status Verified: 2024-05
• Study Completion: 2024-05-15
• Last Update Submitted: 2024-05-28
• Last Update Posted: 2024-05-30

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 9

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MitraClip	Medical Therapy	Study of MitraClip in symptomatic heart failure patients with moderate (2+, 2-3+) functional mitral regurgitation and left ventricular dysfunction. Subjects will be followed for 24 months and there will be one formal interim analysis for futility after approximately 50% of subjects have completed their 24-month follow-up.
Medical Therapy	MitraClip	Study of medical therapy in symptomatic heart failure patients with moderate (2+, 2-3+) functional mitral regurgitation and left ventricular dysfunction. Subjects will be followed for 24 months and there will be one formal interim analysis for futility after approximately 50% of subjects have completed their 24-month follow-up.
Medical Therapy	Medical Therapy	Study of medical therapy in symptomatic heart failure patients with moderate (2+, 2-3+) functional mitral regurgitation and left ventricular dysfunction. Subjects will be followed for 24 months and there will be one formal interim analysis for futility after approximately 50% of subjects have completed their 24-month follow-up.
MitraClip	MitraClip	Study of MitraClip in symptomatic heart failure patients with moderate (2+, 2-3+) functional mitral regurgitation and left ventricular dysfunction. Subjects will be followed for 24 months and there will be one formal interim analysis for futility after approximately 50% of subjects have completed their 24-month follow-up.

Primary Outcome Measures

Name	Time	Method
Change In Mitral Regurgitation	24 months	To compare the effectiveness of treatment with MitraClip to medical therapy on the change from baseline to 24 months in quality of life as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ) overall summary score in patients with moderate functional mitral regurgitation

Secondary Outcome Measures

Name	Time	Method
Change in Mitral Regurgitation Severity at 12 Months	12 months	To evaluate the effects of MitraClip and medical therapy on change from baseline in mitral regurgitation severity at 12 months.
Change in Quality of Life Assessment	12 months	To evaluate the effects of MitraClip and medical therapy on change in quality of life from baseline to 12 months, as measured by the KCCQ.
Change in Mitral Regurgitation Severity at 24 Months	24 months	To evaluate the effects of MitraClip and medical therapy on change from baseline in mitral regurgitation severity at 24 months.

Trial Locations

Locations (1)

Montreal Heart Institute; 🇨🇦 Montreal, Quebec, Canada