Randomized Trial of the Neochord DS1000 System Versus Open Surgical Repair

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
* Anatomic and general suitability

Exclusion Criteria:

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

Conditions2

Locations18 sites

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