Status:
COMPLETED
CARDINAL Adjustable Annuloplasty Ring System For Treatment of Mitral Regurgitation
Lead Sponsor:
Edwards Lifesciences
Conditions:
Mitral Valve Insufficiency
Eligibility:
All Genders
18-80 years
Phase:
NA
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, ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2014
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT01137734
Start Date
March 1 2010
End Date
January 1 2014
Last Update
November 5 2021
Active Locations (2)
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1
Hugo Vanermen
Aalst, Belgium, B-9300
2
Hospital San Raffaele
Milan, Italy, 20132