Clinical Trial: CARDINAL Adjustable Annuloplasty Ring System For Treatment of Mitral Regurgitation

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Valtech Cardinal Adjustable Semi-Rigid Annuloplasty Ring System For Treatment of Mitral Valve Regurgitation in Open Surgical Repair

Brief Summary: Annuloplasty device for repair of mitral valve regurgitation with option to adjust device post implant off pump, to optimize correction of mitral regurgitation. Unlike conventional annuloplasty ring, 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.

Detailed Summary:
Sponsor: Valtech Cardio Ltd

Current Primary Outcome: Performance and safety [ Time Frame: Number 1 and 2 procedure. Number 3. at 6 month ]

Following are the primary endpoints:

  1. Technical Success Rate of the implantation
  2. Technical feasibility of "off pump" adjustment, when required, of the Valtech Cardinal Ring
  3. Reduction of mitral valve regurgitation (MR)


Original Primary Outcome: Same as current

Current Secondary Outcome: safety [ Time Frame: 6 months ]

Incidence of Major Adverse Events (MAE) equal or lower than that reported in the literature.


Original Secondary Outcome: Same as current

Information By: Valtech Cardio Ltd

Dates:
Date Received: May 24, 2010
Date Started: March 2010
Date Completion:
Last Updated: December 22, 2014
Last Verified: December 2014