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MitraClip REPAIR MR Study

NCT04198870 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 500

Last updated 2026-05-15

No results posted yet for this study

Summary

The objective of this randomized controlled trial (RCT) is to compare the clinical outcome of MitraClip™ device versus surgical repair in patients with severe primary MR who are at moderate surgical risk and whose mitral valve has been determined to be suitable for correction by MV repair surgery by the cardiac surgeon on the local site heart team.

Conditions

  • Mitral Valve Regurgitation

Interventions

DEVICE

MitraClip™ device implantation

Transcatheter repair of the mitral valve using MitraClip™ device

PROCEDURE

Mitral Valve Repair Surgery

Surgical repair of the mitral valve

Sponsors & Collaborators

  • Abbott Medical Devices

    lead INDUSTRY

Principal Investigators

  • Patrick McCarthy, MD · Northwestern Memorial Hospital

  • Saibal Kar, MD · Los Robles Regional Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-21
Primary Completion
2027-12-31
Completion
2035-12-31
FDA Device
Yes

Countries

  • United States
  • Canada
  • Germany
  • Switzerland

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 NCT04198870 on ClinicalTrials.gov