NeoChord

Protocol: 
AAAQ9584

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

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).

Are you Eligible? (Inclusion Criteria)

  Inclusion Criteria:

  • 21 years of age or older
  • Is a candidate for mitral valve repair with cardiopulmonary bypass
  • Has Grade III moderate or Grade IV severe degenerative mitral valve regurgitation per baseline Echo Core Lab assessment
  • Isolated segmental prolapse of the A2 or P2 segment
  • Anterior leaflet covers at least 65% of anterior-posterior annular distance
  • Anatomic and general suitability

Exclusion Criteria:

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

 

Specialty Area(s)