Randomized Trial of the Neochord DS1000 System Versus Open Surgical Repair

ID#: NCT02803957

Age: 21 years - 66+

Gender: All

Healthy Subjects: No

Study Phase: N/A

Recruitment Status: Recruiting

Start Date: November 01, 2016

End Date: July 01, 2025

Contact Information:
David H Adams, MD
Michael Borger, MD, Ph.D.
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).

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