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).
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).
Randomized Trial of the Neochord DS1000 System Versus Open Surgical Repair
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Sutter Health/Alta Bates Summitt Medical Center, Oakland, California, United States, 94609
Mercy General Hospital, Sacramento, California, United States, 95819
Stanford University, Stanford, California, United States, 94305
MedStar Washington Hospital Center, Washington, District of Columbia, United States, 20010
Florida Hospital, Orlando, Florida, United States, 32803
Piedmont Heart Institute, Atlanta, Georgia, United States, 30339
Franciscan Health, Indianapolis, Indiana, United States, 46237
Johns Hopkins University, Baltimore, Maryland, United States, 21287
University of Michigan, Ann Arbor, Michigan, United States, 48109
Mount Sinai, Icahn School of Medicine, New York, New York, United States, 10029
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
For general information about clinical research, read Learn About Studies.
21 Years to
ALL
No
NeoChord,
2027-07