Randomized Trial of the Neochord DS1000 System Versus Open Surgical Repair
Purpose
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).
Condition
- Mitral Valve Insufficiency
Eligibility
- Eligible Ages
- Over 21 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Treatment Group |
Subjects with degenerative mitral valve insufficiency treated with artificial chordae implanted using the NeoChord DS1000 |
|
|
Active Comparator Control Group |
Subjects with degenerative mitral valve insufficiency treated with standard surgical mitral valve repair |
|
Recruiting Locations
MedStar Washington Hospital Center
Washington, District of Columbia 20010
Washington, District of Columbia 20010
More Details
- Status
- Recruiting
- Sponsor
- NeoChord