The Present and FutureClinical StatementClinical Trial Design Principles and Endpoint Definitions for Transcatheter Mitral Valve Repair and Replacement: Part 2: Endpoint Definitions: 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, Valtech. Dr. Stone has served as a consultant for AGA Medical, AstraZeneca, Atrium, Boston Scientific, Cardiovascular Systems, Inc., Eli Lilly/Daiichi Sankyo partnership, 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. 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. 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. Mehran has received grants from AstraZeneca, Bristol-Myers Squibb/Sanofi-Aventis, Lilly/Daiichi Sankyo, and The Medicines Company; serves as a consultant for Abbott Vascular, AstraZeneca, Boston Scientific, Covidien, CSL Behring, Janssen (Johnson & Johnson), Maya Medical, Merck, and Regado Biosciences; and serves as an advisory board member for Covidien, Endothelix, Inc., Janssen, Merck, and Sanofi. Dr. Kuck has received grants and personal fees from Biosense Webster, Medtronic, and St. Jude Medical. Dr. Piazza has served as a consultant for Medtronic; has received grants from Medtronic and St. Jude Medical; and has equity in CardiAQ and Highlife. Dr. Head has received personal fees for lectures and product development from Medtronic. Dr. Filippatos has received grants from Abbott Vascular; and serves as a committee member or principal investigator of trials sponsored by Bayer, Cardiorentis, the European Union, Medtronic, and Novartis. Dr. Vahanian has received personal fees from and served as a consultant for Abbott Vascular, Edwards Lifesciences, and Valtech. 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.