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