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Outcome Measures

Primary Outcomes (1)

Change In Mitral Regurgitation
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
24 months

Secondary Outcomes (3)

Change in Mitral Regurgitation Severity at 24 Months
24 months
Change in Mitral Regurgitation Severity at 12 Months
12 months
Change in Quality of Life Assessment
12 months

Study Arms (2)

MitraClip

EXPERIMENTAL

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.

Device: MitraClipDrug: Medical Therapy

Medical Therapy

ACTIVE COMPARATOR

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.

Device: MitraClipDrug: Medical Therapy

Interventions

MitraClipDevice

Study participants will be randomized to MitraClip device to determine treatment efficacy in improving LV remodelling or functional capacity.

Medical TherapyMitraClip

Medical TherapyDrug

Study participants will be randomized to medical therapy to determine treatment efficacy in improving LV remodelling or functional capacity.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Male or female ≥18 years of age;
Moderate (2+,2-3+) functional mitral regurgitation due to cardiomyopathy of either ischemic or non-ischemic etiology as determined by transthoracic echocardiogram (TTE), and confirmed by the Echocardiography Core Lab (ECL);

Study Design

Study Type

interventional

Phase

not applicable

Allocation

RANDOMIZED

Masking

QUADRUPLE

Who Masked

PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR

Purpose

TREATMENT

Intervention Model

PARALLEL

Model Details: Randomized study of MitraClip vs. 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.

Sponsor Type

OTHER

Responsible Party

SPONSOR

Study Stopped

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Study Arms (2)

MitraClip

Medical Therapy

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Study Arms (2)

MitraClip

Medical Therapy

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations