Clinical Trial: V-Chordal Adjustable System for Chordal Replacement in Mitral Valve Insufficiency Due to Leaflet Prolapse
Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional
Official Title: V-Chordal Adjustable System for Chordal Replacement in Mitral Valve Insufficiency Due to Leaflet Prolapse
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 Summary:
Sponsor: Valtech Cardio Ltd
Current Primary Outcome:
- Technical success rate [ Time Frame: 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 [ Time Frame: 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.
Original Primary Outcome: Same as current
Current Secondary Outcome: Incidence of Major Adverse Events (MAE). [ Time Frame: 30 days, and 6 months ]
Original Secondary Outcome: Same as current
Information By: Valtech Cardio Ltd
Dates:
Date Received: August 10, 2011
Date Started: November 2010
Date Completion:
Last Updated: December 22, 2014
Last Verified: December 2014