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:

    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 [ 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