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

Sponsor

Edwards Lifesciences (Industry)

Overall Status

Terminated

CT.gov ID

NCT01415947

Collaborator

(none)

Enrollment

Location

Duration (Months)

0.2

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Mitral Leaflet Prolapse	Device: V Chordal	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

5 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Nov 1, 2010

Actual Primary Completion Date :

May 1, 2012

Actual Study Completion Date :

Mar 1, 2013

Outcome Measures

Primary Outcome Measures

Technical success rate [6 months]
ability to: Anchor the system in the papillary muscle; Suture the leaflet; Release the V-Chordal system and extract the delivery system with no lesions to adjacent tissue. Technical feasibility of chordal length adjustment. When required, adjustment of chords after weaning from CPB
Efficacy [30 days and 6 months]
The ability of the V-Chordal System to correct leaflet prolapse of the treated segments as assessed by echordiography. Correction is defined as leaflet displacement <2 mm above the annulus in the septolateral view.

Secondary Outcome Measures

Incidence of Major Adverse Events (MAE). [30 days, and 6 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts 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.