The VARC Valve Academic Research Consortium for transcatheter aortic valve replacement set the standard for selecting appropriate clinical endpoints reflecting safety and effectiveness of transcatheter devices, and defining single and composite clinical endpoints for clinical trials.
No such standardization exists for circumferentially sutured surgical valve paravalvular leak PVL closure. This document seeks to provide core principles, appropriate clinical endpoints, and endpoint definitions to be used in clinical trials of PVL closure devices. The PVL Academic Research Consortium met to review evidence and make recommendations for assessment of disease severity, data collection, and updated endpoint definitions. Unresolved issues in the field are outlined.
The current PVL Academic Research Consortium provides recommendations for assessment of disease severity, data collection, and endpoint definitions. Future research in the field is warranted. Keywords: closure devices; regurgitation; transcatheter. Published by Elsevier Inc. All rights reserved. Abstract The VARC Valve Academic Research Consortium for transcatheter aortic valve replacement set the standard for selecting appropriate clinical endpoints reflecting safety and effectiveness of transcatheter devices, and defining single and composite clinical endpoints for clinical trials.
Publication types Review.
