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Randomized Trial of the Neochord DS1000 System Versus Open Surgical Repair
Sponsor: NeoChord
Summary
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).
Official title: Randomized Trial of the NeoChord™ DS1000™ System Versus Open Surgical Repair
Key Details
Gender
All
Age Range
21 Years - Any
Study Type
INTERVENTIONAL
Enrollment
585
Start Date
2016-11-03
Completion Date
2027-01
Last Updated
2026-04-08
Healthy Volunteers
No
Conditions
Interventions
NeoChord DS1000
Trans-apical, beating heart repair of degenerative mitral valve insufficiency with artificial chordae implanted with the NeoChord DS1000
Surgical Mitral Valve Repair
Surgical repair of degenerative mitral valve insufficiency with cardiopulmonary bypass, and annuloplasty ring and some form of leaflet repair or artificial chordae.
Locations (14)
Mercy General Hospital
Sacramento, California, United States
Stanford University
Stanford, California, United States
MedStar Washington Hospital Center
Washington D.C., District of Columbia, United States
Piedmont Heart Institute
Atlanta, Georgia, United States
Franciscan Health
Indianapolis, Indiana, United States
Johns Hopkins University
Baltimore, Maryland, United States
University of Michigan
Ann Arbor, Michigan, United States
Mount Sinai, Icahn School of Medicine
New York, New York, United States
Columbia University Medical Center
New York, New York, United States
Pinnacle Health
Harrisburg, Pennsylvania, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
St. Thomas
Nashville, Tennessee, United States
Baylor - Plano
Plano, Texas, United States
Valley Health System | Virginia
Winchester, Virginia, United States