Safety and Efficacy Study of the PTMA Device to Reduce Mitral Valve Regurgitation in Patients With Heart Failure

PHASE2/PHASE3SuspendedINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

February 28, 2009

Primary Completion Date

December 31, 2010

Study Completion Date

December 31, 2015

Conditions
Mitral RegurgitationHeart Failure
Interventions
DEVICE

Percutaneous transvenous mitral annuloplasty

Catheterization procedure with anesthesia requiring subclavicular puncture, catheterization of the right atrium and coronary sinus vein, placement and optimization of the PTMA device with access hub remaining subcutaneous at the clavicle.

Trial Locations (3)

K1Y 4W7

University of Ottawa Heart Institute, Ottawa

H3A1A1

Royal Victoria Hospital, McGill University Medical Center, Montreal

G1V4G5

Laval Hospital, Quebec Heart-Lung Institute, Québec

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Duke University

OTHER

collaborator

Medifacts International Corporation

INDUSTRY

lead

Viacor

INDUSTRY