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

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Trial Summary
Trial Overview
Inclusion Criteria

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).


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
Stanford University
450 Serra Mall
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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Stanford, CA
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Johns Hopkins University
3400 N Charles St
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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Baltimore, MD
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University of Michigan
500 S State St
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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Ann Arbor, MI
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Piedmont Heart Institute
Atlanta, Georgia 30309
Principal Investigator: Frederico Milla, MD
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Atlanta, GA
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The Christ Hospital
2139 Auburn Ave
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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Cincinnati, OH
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Pinnacle Health
Harrisburg, Pennsylvania 17043
Principal Investigator: Mubashir Mumtaz, MD
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Harrisburg, PA
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Penn State Milton S. Hershey Medical Center
500 University Dr
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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Hershey, PA
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Franciscan Health
8111 South Emerson Avenue
Indianapolis, Indiana 46237
Principal Investigator: Marc Gerdisch, MD
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from
Indianapolis, IN
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St. Thomas
Nashville, Tennessee 37205
Principal Investigator: Evelio Rodriguez, MD
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from
Nashville, TN
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Mount Sinai Icahn School of Medicine
1 Gustave L. Levy Place
New York, New York 10029
Principal Investigator: David H Adams, MD
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New York, NY
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Columbia University Medical Center
630 W 168th St
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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New York, NY
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Sutter Health/Alta Bates Summitt Medical Center
Oakland, California 94609
Principal Investigator: Junaid Khan, MD
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from
Oakland, CA
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Florida Hospital
601 E Rollins St
Orlando, Florida 32803
(407) 303-5600
Principal Investigator: Kevin Accola, MD
Florida Hospital Florida Hospital is one of the country
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Orlando, FL
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University of Pittsburgh Medical Center
200 Lothrop St
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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Pittsburgh, PA
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Baylor Plano
4700 Alliance Boulevard
Plano, Texas 75093
Principal Investigator: Robert Smith, MD
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Plano, TX
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Mercy General Hospital
Sacramento, California 95819
Principal Investigator: Frank Slachman, MD
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Sacramento, CA
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MedStar Washington Hospital Center
Washington, District of Columbia
Principal Investigator: Vinod Thourani, MD
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from
Washington,
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Valley Health System | Virginia
Winchester, Virginia 22601
Principal Investigator: Basel Ramlawi, MD
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Winchester, VA
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