CARDINAL Adjustable Annuloplasty Ring System For Treatment of Mitral Regurgitation

NACompletedINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

March 31, 2010

Primary Completion Date

February 29, 2012

Study Completion Date

January 31, 2014

Conditions
Mitral Valve Insufficiency
Interventions
DEVICE

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

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.

Trial Locations (2)

20132

Hospital San Raffaele, Milan

B-9300

Hugo Vanermen, Aalst

Sponsors
All Listed Sponsors
lead

Edwards Lifesciences

INDUSTRY