30
Participants
Start Date
March 31, 2010
Primary Completion Date
February 29, 2012
Study Completion Date
January 31, 2014
Adjustable Annuloplasty Ring with option to adjust off pump.
Annuloplasty device repair of mitral valve regurgitation with option to adjust device post implant off pump, to optimize correction of mitral regurgitation. Unlike conventional annuloplasty repair, the Cardinal system offers the clinician the opportunity to make adjustments after weaning from cardiopulmonary bypass. Adjustability is expected to reduce the number of patients leaving the operating room with residual regurgitation after mitral valve repair.
Device: Adjustable Annuloplasty Ring (with option to adjust off-pump)
Evaluate the performance and safety of the investigational adjustable annuloplasty ring device for the treatment of mitral regurgitation, with option to adjust on and off-pump.
Hospital San Raffaele, Milan
Hugo Vanermen, Aalst
Lead Sponsor
Edwards Lifesciences
INDUSTRY