2
Participants
Start Date
March 31, 2008
Primary Completion Date
March 31, 2010
Study Completion Date
March 31, 2010
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.
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.
Duke University Medical Center, Durham
Morehouse School of Medicine, Atlanta
Minnesota Heart Failure Network, Minneapolis
Mayo Clinic, Rochester
Baylor College of Medicine, Houston
University of Utah Health Sciences Center, Murray
Brigham and Women's Hospital, Boston
University of Vermont - Fletcher Allen Health Care, Burlington
Montreal Heart Institute, Montreal
Lead Sponsor
Collaborators (1)
National Heart, Lung, and Blood Institute (NHLBI)
NIH
Heart Failure Clinical Research Network
UNKNOWN
Duke University
OTHER