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

NCT03705312 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 174

Last updated 2019-08-14

No results posted yet for this study

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.

Conditions

  • Mitral Regurgitation
  • Heart Failure
  • Mitral Valve Regurgitation Due to Cardiomyopathy (Disorder)

Interventions

DEVICE

Transcatheter mitral valve repair

Transcatheter mitral valve repair performed using the MitraClip device

OTHER

Guideline-directed medical therapy

Standard medical therapy for heart failure as recommended by HF guidelines

Sponsors & Collaborators

  • Abbott Medical Devices

    collaborator INDUSTRY

  • Montreal Heart Institute

    lead OTHER

Principal Investigators

  • Anita W Asgar, MD · Montreal Heart Institute

  • Anique Ducharme, MD · Montreal Heart Institute

  • Jean L Rouleau, MD · Montreal Heart Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-02-22
Primary Completion
2021-12-31
Completion
2022-01-31
FDA Device
Yes

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03705312 on ClinicalTrials.gov