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

NCT03891823 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2024-05-30

No results posted yet for this study

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.

Conditions

  • Ventricular Remodeling, Left

Interventions

DEVICE

MitraClip

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

DRUG

Medical Therapy

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

Sponsors & Collaborators

  • Abbott Medical Devices

    collaborator INDUSTRY

  • Montreal Heart Institute

    lead OTHER

Principal Investigators

  • Jean Rouleau, MD · Montreal Heart Institute

  • Anique Ducharme, MD · Montreal Heart Institute

  • Sophie Tanguay, MSc · Montreal Health Innovations Coordinating Centre

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-08
Primary Completion
2024-03-28
Completion
2024-05-15

Countries

  • Canada

Study Locations

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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 NCT03891823 on ClinicalTrials.gov