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

Phase 2

Terminated

• Conditions: Mitral Leaflet Prolapse

• Registration Number: NCT01415947
• Lead Sponsor: Edwards Lifesciences

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-11
• Study First Submitted: 2011-08-10
• Study First Submitted QC: 2011-08-11
• Study First Posted: 2011-08-12
• Primary Completion: 2012-05
• Study Completion: 2013-03
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-22
• Last Update Posted: 2014-12-23

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 5

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Technical success rate	6 months	ability to: 1. Anchor the system in the papillary muscle; 2. Suture the leaflet; 3. Release the V-Chordal system and extract the delivery system with no lesions to adjacent tissue.; 4. 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

Name	Time	Method
Incidence of Major Adverse Events (MAE).	30 days, and 6 months

Trial Locations

Locations (1)

HSR; 🇮🇹 Milano, Italy