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CARDINAL Adjustable Annuloplasty Ring System For Treatment of Mitral Regurgitation | Clinical Trials | Clareo Health

COMPLETEDNA

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

NCT01137734•Edwards Lifesciences

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 80 years

Sex

ALL

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.
+1 more criteria

Locations (2)

Hugo Vanermen

Aalst, Belgium

Hospital San Raffaele

Milan, Italy

Key Dates

Start Date

March 1, 2010

Primary Completion Date

February 1, 2012

Completion Date

January 1, 2014

Last Updated

November 5, 2021

Enrollment

ACTUAL participants

Conditions

Mitral Valve Insufficiency

Interventions

Adjustable Annuloplasty Ring with option to adjust off pump.

DEVICE

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

DEVICE

DragonFly EU Pivotal Study

NCT05927441

Mitral Valve Insufficiency

View study

RECRUITINGNA

The EMPOWER Trial - The Carillon Mitral Contour System® in Treating Heart Failure With at Least Mild FMR

NCT03142152

Functional Mitral RegurgitationHeart Failure+4 more

View study

RECRUITING

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 5, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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CARDINAL Adjustable Annuloplasty Ring System For Treatment of Mitral Regurgitation

Inclusion Criteria

Exclusion Criteria

DragonFly EU Pivotal Study

The EMPOWER Trial - The Carillon Mitral Contour System® in Treating Heart Failure With at Least Mild FMR

Clinical Outcomes of Edwards Lifesciences MITRIS RESLILA Mitral Valve in the Asian Population

Prognostic Impact of Imaging Parameters in Patients With Primary Mitral Insufficiency by Prolapse (COHORTE-IM)

The Half Moon Transcatheter Mitral Valve Repair (TMVr) Pilot Study

The CorCinch - Functional Mitral Valve Regurgitation (FMR) Study