The Present and FutureClinical StatementClinical 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
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For complete information on the MVARC members and participants, please see the Online Appendix. The MVARC initiative was funded by unrestricted grant support from Abbott Vascular, Boston Scientific, Cardiac Dimensions, Cordis, Edwards Lifesciences, Guided Delivery Systems Inc., Mitralign, Medtronic, and Valtech. Dr. Stone has served as a consultant for AGA Medical, AstraZeneca, Atrium, Boston Scientific, Cardiovascular Systems, Inc., Eli Lilly/Daiichi Sankyo, InfraReDx, InspireMD, Miracor, Osprey, Reva, TherOx, Thoratec, Velomedix, and Volcano; and has equity in the Biostar and MedFocus family of funds, Caliber, Guided Delivery Systems, MiCardia, and Vascular Nanotransfer Technologies. Dr. Vahanian has received personal fees from Abbott Vascular, Edwards Lifesciences, and Valtech; has served as a consultant for Abbott Vascular and Valtech; and has received honoraria from Edwards Lifesciences. Dr. Adams has received royalties for intellectual property paid to his medical institution from Edwards Lifesciences and Medtronic. Dr. Abraham has served as a consultant for Abbott Vascular, Novartis, and St. Jude Medical/CardioMEMS; and was coprincipal investigator for the COAPT trial of MitraClip sponsored by Abbott Vascular. Dr. Borer has served as a consultant for Amgen, ARMGO, BioMarin, Boehringer Ingelheim, Celgene, Cleveland BioLabs, JenaValve, Salix, Sanofi, and Servier; and serves as a committee member for Cardiorentis, Celladon, the National Heart, Lung, and Blood Institute, Novartis, Pfizer, Somahlution, and Takeda USA. Dr. Cutlip has received research support from Medtronic, Boston Scientific, and Abbott Vascular. Dr. Krucoff has received grants and personal fees from and served as a consultant for Abbott Vascular, Boston Scientific, and Medtronic. Dr. Blackstone has received grants from Edwards Lifesciences. Dr. Généreux has received grants from Cardiac Dimensions, Inc.; and serves as a consultant/speaker for Abbott Vascular, Cardiovascular Systems, Inc., and Edwards Lifesciences. Dr. Mack has served as a coprincipal investigator of trials on transcatheter mitral valve replacement and MitraClip therapy. Dr. Grayburn has served as a consultant for Abbott Vascular, Bracco Diagnostics, and Tendyne Holdings; has received grants from Abbott Vascular, Edwards Lifesciences, Guided Delivery Systems, Medtronic, Tendyne Holdings, and Valtech Cardio; has received personal fees from Abbott Vascular, Bracco Diagnostics, and Tendyne Holdings; and has served as a consultant to Tendyne Holdings. Dr. Filippatos has received grants from Abbott Vascular; and serves as a committee member or principal investigator of trials sponsored by Bayer, Cardiorentis, European Union, Medtronic, and Novartis. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose. Saibal Kar, MD, served as Guest Editor for this paper.