CompletedNot Applicable

CARDINAL Adjustable Annuloplasty Ring System For Treatment of Mitral Regurgitation

Belgium, Italy30 participantsStarted 2010-03

Plain-language 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.

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: Day of surgery

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

Timeframe: Day of surgery

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

Timeframe: 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

Timeframe: Day of discharge compared to baseline.

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

Timeframe: 30 days compared to baseline.

Trial details

NCT IDNCT01137734

SponsorEdwards Lifesciences

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2012-02

View on ClinicalTrials.gov More Mitral Valve Insufficiency trials

Plain-language summary

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

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

Timeframe: Day of surgery

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

Timeframe: Day of surgery

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

Timeframe: 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

Timeframe: Day of discharge compared to baseline.

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

Timeframe: 30 days compared to baseline.