Study Overview

Details

NCTId: NCT02803957

Status: Recruiting

Condition: Mitral Valve Insufficiency

Study Type: Interventional

Sponsor: NeoChord

Study Description

Brief

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

Criteria:

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

Healthy Volunteers: No

Gender: All

Min Age: 21 Years

Contacts

Valley Health System | Virginia

Recruiting

Winchester

Virginia

22601

United States

Basel Ramlawi, MD

Principal Investigator