V-Chordal Adjustable System for Chordal Replacement in Mitral Valve Insufficiency Due to Leaflet Prolapse
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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||V-Chordal Adjustable System for Chordal Replacement in Mitral Valve Insufficiency Due to Leaflet Prolapse|
- Technical success rate [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
- 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 [ Time Frame: 30 days and 6 months ] [ Designated as safety issue: No ]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.
- Incidence of Major Adverse Events (MAE). [ Time Frame: 30 days, and 6 months ] [ Designated as safety issue: Yes ]
|Study Start Date:||November 2010|
|Estimated Study Completion Date:||November 2013|
|Primary Completion Date:||May 2012 (Final data collection date for primary outcome measure)|
Device: V Chordal