Effectiveness of Surgical Mitral Valve Repair Versus Medical Treatment for People With Significant Mitral Regurgitation and Non-ischemic Congestive Heart Failure

PHASE3TerminatedINTERVENTIONAL
Enrollment

2

Participants

Timeline

Start Date

March 31, 2008

Primary Completion Date

March 31, 2010

Study Completion Date

March 31, 2010

Conditions
Mitral Valve InsufficiencyHeart Failure
Interventions
PROCEDURE

Surgical mitral valvuloplasty with placement of annular ring (SMVR)

Participants will undergo open heart surgery to mechanically reduce mitral regurgitation (MR). A complete rigid or semi-rigid annular ring will be placed unless specifically contraindicated by intraoperative findings. The ring size will be between 24 mm and 27 mm in the anteroposterior diameter. Annular ring sutures will be placed circumferentially approximately 1 mm off the hinge point between the leaflet and the atrial tissue. The total number of sutures will vary between 4 and 7 sutures anteriorly, while 8 to 12 sutures will be utilized for the posterior segment of the annulus. Additional repair of the mitral apparatus itself will be based on intraoperative findings. Leaflet repair will be performed for significant prolapse. Submitral apparatus repair will be performed for ruptured or significantly elongated chordae as well as significant chordal tethering.

DRUG

Optimal medical therapy (OMT)

Optimal medical therapy can include, but is not limited to, any of the following treatment regimens: combination of vasodilator therapy and diuretics, nitrates and nifedipine, and beta-adrenergic blocker therapy.

Trial Locations (9)

27705

Duke University Medical Center, Durham

30310

Morehouse School of Medicine, Atlanta

55415

Minnesota Heart Failure Network, Minneapolis

55905

Mayo Clinic, Rochester

77030

Baylor College of Medicine, Houston

84107

University of Utah Health Sciences Center, Murray

02115

Brigham and Women's Hospital, Boston

05401

University of Vermont - Fletcher Allen Health Care, Burlington

H1T - 1C8

Montreal Heart Institute, Montreal

Sponsors
All Listed Sponsors
collaborator

National Heart, Lung, and Blood Institute (NHLBI)

NIH

collaborator

Heart Failure Clinical Research Network

UNKNOWN

lead

Duke University

OTHER