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 Sex
- 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
Sutter Health/Alta Bates Summitt Medical Center
Oakland 5378538, California 5332921 94609
Oakland 5378538, California 5332921 94609
Mercy General Hospital
Sacramento 5389489, California 5332921 95819
Sacramento 5389489, California 5332921 95819
Stanford University
Stanford 5398563, California 5332921 94305
Stanford 5398563, California 5332921 94305
MedStar Washington Hospital Center
Washington D.C. 4140963, District of Columbia 4138106 20010
Washington D.C. 4140963, District of Columbia 4138106 20010
Piedmont Heart Institute
Atlanta 4180439, Georgia 4197000 30339
Atlanta 4180439, Georgia 4197000 30339
Franciscan Health
Indianapolis 4259418, Indiana 4921868 46237
Indianapolis 4259418, Indiana 4921868 46237
Johns Hopkins University
Baltimore 4347778, Maryland 4361885 21287
Baltimore 4347778, Maryland 4361885 21287
University of Michigan
Ann Arbor 4984247, Michigan 5001836 48109
Ann Arbor 4984247, Michigan 5001836 48109
Mount Sinai, Icahn School of Medicine
New York 5128581, New York 5128638 10029
New York 5128581, New York 5128638 10029
Columbia University Medical Center
New York 5128581, New York 5128638 10032
New York 5128581, New York 5128638 10032
Pinnacle Health
Harrisburg 5192726, Pennsylvania 6254927 17110
Harrisburg 5192726, Pennsylvania 6254927 17110
University of Pittsburgh Medical Center
Pittsburgh 5206379, Pennsylvania 6254927 15232
Pittsburgh 5206379, Pennsylvania 6254927 15232
St. Thomas
Nashville 4644585, Tennessee 4662168 37205
Nashville 4644585, Tennessee 4662168 37205
Baylor - Plano
Plano 4719457, Texas 4736286 75093
Plano 4719457, Texas 4736286 75093
Valley Health System | Virginia
Winchester 4794120, Virginia 6254928 22601
Winchester 4794120, Virginia 6254928 22601
More Details
- Status
- Recruiting
- Sponsor
- NeoChord