NCT01137734

CARDINAL Adjustable Annuloplasty Ring System For Treatment of Mitral Regurgitation

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Edwards Lifesciences · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Mitral Valve Insufficiency

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2010-03-01
• Primary completion: 2012-02-01
• Completion: 2014-01-01
• First posted: 2010-06-04
• Last updated: 2021-11-05

Locations

2 sites across 2 countries: Belgium, Italy