Document Detail


The EVEREST II Trial: design and rationale for a randomized study of the evalve mitraclip system compared with mitral valve surgery for mitral regurgitation.
MedLine Citation:
PMID:  20598968     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
BACKGROUND: 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.
STUDY DESIGN: 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.
CONCLUSIONS: 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.
Authors:
Laura Mauri; Pallav Garg; Joseph M Massaro; Elyse Foster; Donald Glower; Paul Mehoudar; Ferolyn Powell; Jan Komtebedde; Elizabeth McDermott; Ted Feldman
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Publication Detail:
Type:  Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  American heart journal     Volume:  160     ISSN:  1097-6744     ISO Abbreviation:  Am. Heart J.     Publication Date:  2010 Jul 
Date Detail:
Created Date:  2010-07-05     Completed Date:  2010-08-17     Revised Date:  2011-08-25    
Medline Journal Info:
Nlm Unique ID:  0370465     Medline TA:  Am Heart J     Country:  United States    
Other Details:
Languages:  eng     Pagination:  23-9     Citation Subset:  AIM; IM    
Copyright Information:
Copyright (c) 2010 Mosby, Inc. All rights reserved.
Affiliation:
Brigham & Women's Hospital, Boston, MA, USA. mauri1@partners.org
Data Bank Information
Bank Name/Acc. No.:
ClinicalTrials.gov/NCT00209274
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MeSH Terms
Descriptor/Qualifier:
Follow-Up Studies
Heart Catheterization / instrumentation*
Heart Valve Prosthesis*
Heart Valve Prosthesis Implantation / instrumentation*
Humans
Mitral Valve Insufficiency / mortality,  surgery*
Prospective Studies
Prosthesis Design
Survival Rate
Treatment Outcome
United States / epidemiology
Comments/Corrections
Comment In:
Am Heart J. 2011 Jul;162(1):e11-2; author reply e13   [PMID:  21742074 ]

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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