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).
Eligibility:
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
