Randomized Trial of the Neochord DS1000 System Versus Open Surgical Repair (ReChord)

  • STATUS
    Recruiting
  • End date
    Jul 23, 2027
  • participants needed
    585
  • sponsor
    NeoChord
Updated on 26 January 2022
regurgitation
cardiopulmonary bypass
mitral valve disease
annuloplasty
mitral valve repair
prolapse

Summary

The objective of this trial is to assess the safety and effectiveness of the study device in subjects with degenerative mitral valve disease receiving a mitral valve repair without cardiopulmonary bypass (treatment group) when compared to subjects receiving mitral valve repair using standard surgical techniques with cardiopulmonary bypass (control group).

Details
Condition Mitral Valve Insufficiency
Treatment NeoChord DS1000, Surgical Mitral Valve Repair
Clinical Study IdentifierNCT02803957
SponsorNeoChord
Last Modified on26 January 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Is a candidate for mitral valve repair with cardiopulmonary bypass
Has Grade III moderate or Grade IV severe degenerative mitral valve regurgitation
Primary segmental prolapse of the A2 or P2 segment or prolapse extending to an adjacent segment (P1, P3, A1, A3) who have a single eccentric regurgitant jet on echocardiogram
Anterior leaflet covers at least 65% of anterior-posterior annular distance or an anterior leaflet that would provide sufficient coaptation after chord placement
Anatomic and general suitability

Exclusion Criteria

Prior mitral valve surgery
Concomitant cardiac procedures
Other cardiac procedures within 3 months
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