Comparing a new device for mitral valve repair to traditional surgery
Randomized Trial of the NeoChord™ DS1000™ System Versus Open Surgical Repair
This study is testing a new device for fixing heart valve problems to see if it works better and helps patients recover faster than traditional surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 585 (estimated) |
| Ages | 21 Years and up |
| Sex | All |
| Sponsor | NeoChord Industry-sponsored |
| Locations | 18 sites (Oakland, California and 17 other locations) |
| Trial ID | NCT02803957 on ClinicalTrials.gov |
What this trial studies
This trial evaluates the safety and effectiveness of the NeoChord DS1000 system for repairing degenerative mitral valve disease without the use of cardiopulmonary bypass. Participants will be randomly assigned to receive either the NeoChord device or standard surgical repair techniques. The study aims to determine if the new device offers advantages over traditional methods in terms of patient outcomes and recovery. It focuses on patients with moderate to severe mitral valve regurgitation and specific anatomical criteria.
Who should consider this trial
Good fit: Ideal candidates are individuals with Grade III or IV degenerative mitral valve regurgitation who are suitable for mitral valve repair.
Not a fit: Patients who have had prior mitral valve surgery or require additional cardiac procedures may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to less invasive mitral valve repair options with improved recovery times for patients.
How similar studies have performed: Other studies have explored minimally invasive techniques for mitral valve repair, showing promising results, but this specific device's approach is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Oakland, California and 17 other locations
- Sutter Health/Alta Bates Summitt Medical Center — Oakland, California, United States (Recruiting)
- Mercy General Hospital — Sacramento, California, United States (Recruiting)
- Stanford University — Stanford, California, United States (Recruiting)
- MedStar Washington Hospital Center — Washington, District of Columbia, United States (Recruiting)
- Florida Hospital — Orlando, Florida, United States (Withdrawn)
- Piedmont Heart Institute — Atlanta, Georgia, United States (Recruiting)
- Franciscan Health — Indianapolis, Indiana, United States (Recruiting)
- Johns Hopkins University — Baltimore, Maryland, United States (Recruiting)
- University of Michigan — Ann Arbor, Michigan, United States (Recruiting)
- Mount Sinai, Icahn School of Medicine — New York, New York, United States (Recruiting)
- Columbia University Medical Center — New York, New York, United States (Recruiting)
- The Christ Hospital — Cincinnati, Ohio, United States (Withdrawn)
- Pinnacle Health — Harrisburg, Pennsylvania, United States (Recruiting)
- Penn State Milton S. Hershey Medical Center — Hershey, Pennsylvania, United States (Withdrawn)
- University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States (Recruiting)
- St. Thomas — Nashville, Tennessee, United States (Recruiting)
- Baylor - Plano — Plano, Texas, United States (Recruiting)
- Valley Health System | Virginia — Winchester, Virginia, United States (Recruiting)
Study contacts
- Study coordinator: David H Adams, MD
- Email: david.adams@mountsinai.org
- Phone: 212-659-6820
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.