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