医学
二尖瓣夹子
二尖瓣反流
随机对照试验
二尖瓣修补术
外科
二尖瓣
心房颤动
冲程(发动机)
临床终点
心脏病学
心力衰竭
心肌梗塞
内科学
机械工程
工程类
作者
Laura Mauri,Pallav Garg,Joseph M. Massaro,Elyse Foster,Donald D. Glower,Paul Mehoudar,F.R.C.P.C. Julie Powell,Jan Komtebedde,Elizabeth McDermott,Ted Feldman
标识
DOI:10.1016/j.ahj.2010.04.009
摘要
Mitral valve surgery is the standard of care for patients with symptomatic mitral regurgitation (MR) or asymptomatic MR with evidence of left ventricular dysfunction or dilation. Whether an endovascular approach to repair can offer comparable effectiveness with improved safety remains to be determined in randomized trials.The EVEREST II Trial is a multicenter, randomized controlled trial to evaluate the benefits and risks of endovascular mitral valve repair using the MitraClip device compared with open mitral valve surgery (control) in patients with moderate or severe MR. Using a 2:1 randomization ratio, the trial is enrolling up to 186 MitraClip-treated subjects and 93 control subjects. Trial end points include a primary efficacy end point: the proportion of patients free from death, surgery for valve dysfunction, and with moderate-severe (3+) or severe (4+) MR at 12 months; the primary safety end point includes the proportion of patients with death, myocardial infarction, reoperation, nonelective cardiovascular surgery, stroke, renal failure, deep would infection, ventilation >48 hours, gastrointestinal complication, new permanent atrial fibrillation, septicemia, or transfusion of >or=2 U at 30 days or hospital discharge, whichever is longer.This randomized controlled trial is designed to evaluate the performance of endovascular mitral repair in comparison to open mitral valve surgery in patients with significant MR.
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