Status:
TERMINATED
V-Chordal Adjustable System for Chordal Replacement in Mitral Valve Insufficiency Due to Leaflet Prolapse
Lead Sponsor:
Edwards Lifesciences
Conditions:
Mitral Leaflet Prolapse
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
The V-Chordal System is a new technology for mitral repair. The Valtech V-Chordal system, consists in the ability to adjust (elongate or shorten) the neochordae "off-pump" to achieve an optimal coapta...
Eligibility Criteria
Inclusion
- Age \> 18 years
- Degenerative mitral insufficiency with mitral leaflet prolapsed , who are candidates for mitral valve repair according to ESC or ACC/AHA guidelines.
- 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
- Inadequate echocardiographic window for transthoracic imaging
- 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 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 :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2013
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT01415947
Start Date
November 1 2010
End Date
March 1 2013
Last Update
December 23 2014
Active Locations (1)
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1
HSR
Milan, Italy, 20132