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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
585
Trans-apical, beating heart repair of degenerative mitral valve insufficiency with artificial chordae implanted with the NeoChord DS1000
Surgical repair of degenerative mitral valve insufficiency with cardiopulmonary bypass, and annuloplasty ring and some form of leaflet repair or artificial chordae.
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
Proportion of subjects free of Major Adverse Events (MAEs) in the treatment group when compared to subjects in the control group.
Time frame: Post-operative Day (POD) 30
Proportion of subjects free of Grade II, III or IV mitral regurgitation, mitral valve replacement or mitral valve reintervention in the treatment group when compared to subjects in the control group.
Time frame: 1 year
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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
...and 4 more locations