Mitral Regurgitation Clinical Trial
Official title:
Pivotal Study: A Study of the Evalve Cardiovascular Valve Repair System - Endovascular Valve Edge-to-Edge REpair STudy (EVERESTIIRCT)
EVEREST II Randomized Controlled Trial (RCT) is a prospective, multi-center, randomized study of the MitraClip® System in the treatment of mitral valve regurgitation, randomizing patients to MitraClip or mitral valve surgery. The EVEREST II High Risk Registry (HRR) study is a prospective multi-center study of the MitraClip System for the treatment of mitral valve regurgitation in high surgical risk patients. Enrollment in the RCT and HRR is closed. A continued access prospective, multi-center study (REALISM) of the MitraClip System in a surgical population (non-high risk arm) and a high surgical risk population (high risk arm) is ongoing. Enrollment in the non-high risk arm of REALISM is closed. Enrollment in the high risk arm of REALISM is ongoing. Patients enrolled in EVEREST II undergo 30-day, 6-month, 12-month, 18-month and 24-month clinical and echocardiographic follow-up, and then annually for 5 years.
Prospective, multi-center, randomized study of the safety and effectiveness of an
endovascular approach to the treatment of mitral valve regurgitation using the Evalve
Cardiovascular Valve Repair System (MitraClip® implant).
A minimum of 279 evaluable patients randomized 2:1 to MitraClip or mitral valve surgery,
respectively, are required to test the primary safety and effectiveness endpoints of the RCT.
Enrollment in the RCT is now complete. 60 roll-in patients were enrolled under EVEREST II
RCT.
38 clinical sites throughout the US and Canada have participated in the RCT and HRR. 37 US
sites are participating in REALISM.
The RCT is powered to test the hypothesis MitraClip has both superiority of safety and
non-inferiority of effectiveness compared to mitral valve repair or replacement surgery. The
HRR is powered to show lower mortality at 30 days with the MitraClip than predicted surgical
mortality.
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