The purpose of this prospective, randomized, multi-center, pivotal trial is to compare the safety and effectiveness of the off-pump, closed heart Coapsys System (Myocor, Inc.) to open surgical repair of the mitral valve using an annuloplasty ring or band in patients with moderate to severe functional mitral regurgitation.
Patient clinical evaluations will consist of 3-month, 6-month, and 12-month follow up of the primary endpoints. Additional follow up of 18-month, 24-month, and annually thereafter will also be included.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
250
St. Joseph's Hospital of Atlanta
Atlanta, Georgia, United States
Prairie Research and Education Group
Springfield, Illinois, United States
St. Joseph's Mercy Hospital
Ann Arbor, Michigan, United States
Primary effectiveness endpoint to compare the mean change in MR grade in the Coapsys group to the open-heart annuloplasty group from baseline to 12 months.
Time frame: 12- months
The primary safety endpoint is to compare the rate of primary adverse events (PAE's) through 12 months in the Coapsys group to the PAE rate in the open-heart annuloplasty group.
Time frame: 12- months
Compare heart failure symptoms, left ventricular geometry, change in MR and TR, adverse events, and hospitalization time and costs of Coapsys group to control group
Time frame: 12 months
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Covenant Healthcare
Saginaw, Michigan, United States
Nebraska Heart Institute
Lincoln, Nebraska, United States
New York University
New York, New York, United States
Lenox Hill Hospital
New York, New York, United States
Duke University
Durham, North Carolina, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
VA Pittsburgh
Pittsburgh, Pennsylvania, United States