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Clinical Trial Design Principles and Endpoint Definitions for Transcatheter Mitral Valve Repair and Replacement: Part 1: Clinical Trial Design Principles: A Consensus Document From the Mitral Valve Academic Research Consortium

Monday, July 27, 2015

Submitted by

Stuart Head

Source

Source Name: European Heart Journal

Source URL: http://www.ncbi.nlm.nih.gov/pubmed/26170467

Author(s)

Stone GW, Vahanian AS, Adams DH, Abraham WT, Borer JS, Bax JJ, Schofer J, Cutlip DE, Krucoff MW, Blackstone EH, Généreux P, Mack MJ, Siegel RJ, Grayburn PA, Enriquez-Sarano M, Lancellotti P, Filippatos G, Kappetein AP; Mitral Valve Academic Research Consortium (MVARC)

Clinical trials evaluating transcatheter mitral valve interventions for severe mitral regurgitation (MR) are complex. The Mitral Valve Academic Research Consortium has provided a 2-part document with recommendations related to diagnosis of MR, patient selection for trials, trial designs and endpoint definitions that are instrumental for the evaluation of all treatments related to severe MR.