pivotal study of a percutaneous mitral valve repair system

Conditions: Mitral Valve Insufficiency; Mitral Valve Regurgitation; Mitral Valve Incompetence; Mitral Regurgitation; Mitral Insufficiency

Summary: 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.

Eligibility criteria:
key inclusion/exclusion criteria: patients with grade 3 (moderate to severe) or grade 4 (severe) mitral regurgitation (mr) based on american society of echocardiography guidelines: * are 18 years or older. * symptomatic * if asymptomatic, must have new onset of atrial fibrillation, pulmonary hypertension, or evidence of left ventricular dysfunction * are candidates for mitral valve surgery * are candidates for transseptal catheterization * primary regurgitant jet must originate from malcoaptation of the a2 and p2 scallops of the mitral valve * appropriate valve anatomy for mitraclip * does not need other cardiac surgery or any emergency surgery * did not experience myocardial infarction in prior 12 weeks or endovascular procedure in prior 30 days * mitral valve orifice area ≥ 4 cm2 * do not have renal insufficiency * echocardiographic evidence of intracardiac mass, thrombus or vegetation

Keywords: mitral valve insufficiency mitral valve regurgitation mitral valve incompetence mitral regurgitation mitral insufficiency mitral valve mr mitral valve prolapse edge to edge (e2e) alfieri technique mitraclip functional mr degenerative mr echocardiogram cad - coronary artery disease heart failure heart attack everest everest i everest ii realism