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Comparing the Effectiveness of Repairing Versus Replacing the Heart's Mitral Valve in People With Severe Chronic Ischemic Mitral Regurgitation

NCT00807040 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 251

Last updated 2019-03-15

Study results available
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Summary

People with coronary artery disease (CAD) or people who have had a heart attack may develop a leak in the mitral valve of their heart and may therefore need to undergo surgery to fix the valve. The best way to fix the mitral valve remains undetermined. This study will evaluate whether it is better for people with severe mitral valve leakage to undergo a mitral valve replacement procedure or a mitral valve repair procedure.

Conditions

Interventions

PROCEDURE

Mitral Valve Repair with Annuloplasty

The annuloplasty ring will be chosen by the surgeon. The ring is sized to the anterior leaflet and intertrigonal distance. A semi-rigid or rigid annuloplasty ring will be used, and if tethering is present, a subvalvar procedure will be performed.

PROCEDURE

Mitral Valve Replacement

Mitral valve replacement will include complete preservation of the subvalvar apparatus. The technique of preservation, choice of prosthetic valve, and technique of suture placement will be dependent on the surgeon's preference. The prosthetic valve will be tested for paravalvular leaks by using the left ventricular saline infusion test.

Sponsors & Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

    collaborator NIH

  • Canadian Institutes of Health Research (CIHR)

    collaborator OTHER_GOV

  • National Institute of Neurological Disorders and Stroke (NINDS)

    collaborator NIH

  • Icahn School of Medicine at Mount Sinai

    lead OTHER

Principal Investigators

  • Timothy Gardner, MD · Christiana Care Health Services

  • Patrick O'Gara, MD · Brigham and Women's Hospital

  • Annetine C. Gelijns, Ph.D. · Icahn School of Medicine at Mount Sinai

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-12-31
Primary Completion
2013-04-30
Completion
2014-03-31

Countries

  • United States
  • Canada

Study Locations

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Entities

Diseases
Companies

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 NCT00807040 on ClinicalTrials.gov