CARDINAL Adjustable Annuloplasty Ring System For Treatment of Mitral Regurgitation

Edwards Lifesciences30 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Mitral Valve Insufficiency

Interventions

Adjustable Annuloplasty Ring with option to adjust off pump.DEVICE

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)DEVICE

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (2)

Hugo Vanermen

Aalst, Belgium

Hospital San Raffaele

Milan, Italy

Outcomes

Primary Outcomes

Percentage of Subjects with Valtech Cardinal Mitral Heart Valve Device Technical Success

Technical success of the implantation of the Cardinal Ring defined as the ability to size the annulus, place the sutures on the ring, lower the ring onto the valve, adjust the ring to the required size and disconnect the adjustment tool.

Time frame: Day of surgery

Percentage of Subjects with Successful Off Pump Adjustment of their Valtech Cardinal Mitral Annuloplasty Ring

The technical feasibility of "off cardiac bypass pump" adjustment during surgery, when required of the Valtech Cardinal Mitral Heart Valve Annuloplasty Ring.

Time frame: Day of surgery

Subject's Mitral Valve Regurgitation (MR) Post-procedure as Compared to Baseline

The percentage of subjects that had a reduction of their pre-operative mitral regurgitation grade as compared to the mitral regurgitation grade at the end of the procedure with the Valtech Cardinal Mitral Heart Valve Annuloplasty Ring.

Time frame: At the end of the procedure on the day of surgery compared to baseline.

Subject's Mitral Valve Regurgitation (MR) at Discharge as Compared to Baseline

The percentage of subjects that had a reduction of their pre-operative mitral regurgitation grade as compared to the mitral regurgitation grade at hospital discharge with the Valtech Cardinal Mitral Heart Valve Annuloplasty Ring.

Time frame: Day of discharge compared to baseline.

Subject's Mitral Valve Regurgitation (MR) at 30 Days as Compared to Baseline

The percentage of subjects that had a reduction of their pre-operative mitral regurgitation grade as compared to the mitral regurgitation grade at 30 days with the Valtech Cardinal Mitral Heart Valve Annuloplasty Ring.

Time frame: 30 days compared to baseline.

Secondary Outcomes

Data from ClinicalTrials.gov

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