CARDINAL Adjustable Annuloplasty Ring System For Treatment of Mitral Regurgitation

Edwards Lifesciences

Status: Completed

Conditions: Mitral Valve Insufficiency

Treatments: Device: Adjustable Annuloplasty Ring with option to adjust off pump.; Device: Device: Adjustable Annuloplasty Ring (with option to adjust off-pump)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01137734

VC1-1

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient is a candidate for mitral valve repair.
• Patient able and willing to return to the implant center for follow-up visits.
• Able and willing to give informed consent and follow protocol procedures.

Exclusion criteria

• Severe organic lesions with retraction of chordate tendineae, severly fibrotic and immobile leaflets, severely deformed subvalvular apparatus.
• Evolving endocarditis or active endocarditis in the last 3 months.
• Heavily calcified annulus or leaflets.
• Congenital malformation with limited valvular tissue
• Patient requires mitral valve replacement.
• Previously implanted prosthetic mitral valve or annuloplasty ring/band.
• Patient requires aortic or pulmonic valve replacement or repair.
• Patient is pregnant (urine HCG test result positive) or lactating.
• Patient has a major cardiac or non-cardiac disease, which in the investigator's experience produces an unacceptable surgical risk.
• Life expectancy of less than twelve months.
• Patient is participating in concomitant research studies of investigational products

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Valtech Cardinal Mitral Annuloplasty Ring

Experimental group

Description:

All subjects enrolled in the study are implanted with the Valtech Cardinal Mitral Annuloplasty ring.

Treatment:

Device: Device: Adjustable Annuloplasty Ring (with option to adjust off-pump)

Device: Adjustable Annuloplasty Ring with option to adjust off pump.