V-Chordal Adjustable System for Chordal Replacement in Mitral Valve Insufficiency Due to Leaflet Prolapse

Edwards Lifesciences

Status and phase

Terminated

Phase 2

Conditions

Mitral Leaflet Prolapse

Treatments

Device: V Chordal

Study type

Interventional

Funder types

Industry

Identifiers

NCT01415947

CH1-1

Details and patient eligibility

About

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 coaptation. The adjustment mechanism allows overcoming the main problem of chordal replacement by enabling accurate sizing of the chords.

Enrollment

5 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 criteria

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.