Clinical ResearchValvular MedicineStandardized Endpoint Definitions for Transcatheter Aortic Valve Implantation Clinical Trials: A Consensus Report From the Valve Academic Research Consortium
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The Valve Academic Research Consortium (VARC) consists of representatives from several independent Academic Research Organizations, several Surgery and Cardiology Societies, members of the U.S. Food and Drug Administration, and several independent experts (Appendix 1 Valve Academic Research Consortium Contributing Groups, Appendix 2 Valve Academic Research Consortium participants). Grants were provided to the ARC Board including representatives of The Cardiovascular Research Foundation, Cardialysis, Duke Clinical Research Institute and Harvard Clinical Research Institute to cover the costs of travel, meeting rooms, and lodging for academic attendees at the San Francisco and Amsterdam meetings by Edwards Lifesciences and Medtronic Corporation. All funds not utilized for the aforementioned travel-related purposes have been returned to the sponsors. Funding was provided by Cardialysis BV on behalf of the Valve Academic Research Consortium. The VARC meetings involved members of the Interventional Cardiology Devices Branch, of the Office of Device Evaluation, Center for Devices and Radiological Health, USFDA. The opinions or assertions herein are the private views of the authors and are not to be construed as reflecting the views of the FDA. This article is copublished in the European Heart Journal.