Randomized Trial of the Neochord DS1000 System Versus Open Surgical Repair
| Status: | Recruiting |
|---|---|
| Conditions: | Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 21 - Any |
| Updated: | 10/4/2018 |
| Start Date: | November 2016 |
| End Date: | July 2025 |
| Contact: | David H Adams, MD |
| Email: | david.adams@mountsinai.org |
| Phone: | 212-659-6820 |
Randomized Trial of the NeoChord™ DS1000™ System Versus Open Surgical Repair
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).
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 per
baseline Echo Core Lab assessment
- Isolated segmental prolapse of the A2 or P2 segment
- Anterior leaflet covers at least 65% of anterior-posterior annular distance
- Anatomic and general suitability
Exclusion Criteria:
- Prior mitral valve surgery
- Concomitant cardiac procedures
- Other cardiac procedures within 3 months
We found this trial at
18
sites
200 Lothrop St
Pittsburgh, Pennsylvania 15213
Pittsburgh, Pennsylvania 15213
Principal Investigator: Thomas Gleason, MD
University of Pittsburgh Medical Center UPMC is one of the leading nonprofit health systems in...
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3400 N Charles St
Baltimore, Maryland 21205
Baltimore, Maryland 21205
410-516-8000
Principal Investigator: Kenton Zehr, MD
Johns Hopkins University The Johns Hopkins University opened in 1876, with the inauguration of its...
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500 S State St
Ann Arbor, Michigan 48109
Ann Arbor, Michigan 48109
(734) 764-1817
Principal Investigator: Matthew Romano, MD
University of Michigan The University of Michigan was founded in 1817 as one of the...
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2139 Auburn Ave
Cincinnati, Ohio 45219
Cincinnati, Ohio 45219
(513) 585-2000
Principal Investigator: Mario Castillo-Sang, MD
The Christ Hospital For more than 120 years, The Christ Hospital has been a leader...
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500 University Dr
Hershey, Pennsylvania 17033
Hershey, Pennsylvania 17033
(717) 531-6955
Principal Investigator: John Conte, MD
Penn State Milton S. Hershey Medical Center Penn State Milton S. Hershey Medical Center, Penn...
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8111 South Emerson Avenue
Indianapolis, Indiana 46237
Indianapolis, Indiana 46237
Principal Investigator: Marc Gerdisch, MD
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1 Gustave L. Levy Place
New York, New York 10029
New York, New York 10029
Principal Investigator: David H Adams, MD
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630 W 168th St
New York, New York
New York, New York
212-305-2862
Principal Investigator: Isaac George, MD
Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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Oakland, California 94609
Principal Investigator: Junaid Khan, MD
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601 E Rollins St
Orlando, Florida 32803
Orlando, Florida 32803
(407) 303-5600
Principal Investigator: Kevin Accola, MD
Florida Hospital Florida Hospital is one of the country
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450 Serra Mall
Stanford, California 94305
Stanford, California 94305
(650) 723-2300
Principal Investigator: Jack Boyd, MD
Stanford University Stanford University, located between San Francisco and San Jose in the heart of...
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Washington, District of Columbia
Principal Investigator: Vinod Thourani, MD
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Winchester, Virginia 22601
Principal Investigator: Basel Ramlawi, MD
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