CARDINAL Adjustable Annuloplasty Ring System For Treatment of Mitral Regurgitation

Not Applicable

Completed

• Conditions: Mitral Valve Insufficiency
• Interventions: Device: Adjustable Annuloplasty Ring with option to adjust off pump.

• Registration Number: NCT01137734
• Lead Sponsor: Edwards Lifesciences

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 Description

Not available

Study Timeline

• Study Start: 2010-03
• Study First Submitted: 2010-05-24
• Study First Submitted QC: 2010-06-03
• Study First Posted: 2010-06-04
• Primary Completion: 2012-02
• Study Completion: 2014-01
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-29
• Last Update Posted: 2021-11-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Valtech Cardinal Mitral Annuloplasty Ring	Adjustable Annuloplasty Ring with option to adjust off pump.	All subjects enrolled in the study are implanted with the Valtech Cardinal Mitral Annuloplasty ring.

Primary Outcome Measures

Name	Time	Method
Percentage of Subjects with Valtech Cardinal Mitral Heart Valve Device Technical Success	Day of surgery	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.
Percentage of Subjects with Successful Off Pump Adjustment of their Valtech Cardinal Mitral Annuloplasty Ring	Day of surgery	The technical feasibility of "off cardiac bypass pump" adjustment during surgery, when required of the Valtech Cardinal Mitral Heart Valve Annuloplasty Ring.
Subject's Mitral Valve Regurgitation (MR) Post-procedure as Compared to Baseline	At the end of the procedure on the day of surgery 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.
Subject's Mitral Valve Regurgitation (MR) at Discharge as Compared to Baseline	Day of discharge 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.
Subject's Mitral Valve Regurgitation (MR) at 30 Days as Compared to Baseline	30 days 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.

Secondary Outcome Measures

Name	Time	Method
Subject's Device Related Adverse Event Rate	6 months	The percentage of subjects that had a device related adverse event with the Valtech Cardinal Mitral Heart Valve Annuloplasty Ring.

Trial Locations

Locations (2)

Hospital San Raffaele; 🇮🇹 Milano, Italy

Hugo Vanermen; 🇧🇪 Aalst, Belgium