The STS-ACC transcatheter valve therapy national registry: a new partnership and infrastructure for the introduction and surveillance of medical devices and therapies
John D Carroll, Fred H Edwards, Danica Marinac-Dabic, Ralph G Brindis, Frederick L Grover, Eric D Peterson, E Murat Tuzcu, David M Shahian, John S Rumsfeld, Cynthia M Shewan, Kathleen Hewitt, David R Holmes Jr, Michael J Mack, John D Carroll, Fred H Edwards, Danica Marinac-Dabic, Ralph G Brindis, Frederick L Grover, Eric D Peterson, E Murat Tuzcu, David M Shahian, John S Rumsfeld, Cynthia M Shewan, Kathleen Hewitt, David R Holmes Jr, Michael J Mack
Abstract
The Society of Thoracic Surgeons (STS) and American College of Cardiology (ACC) transcatheter valve therapy (TVT) registry is a novel, national registry for all new TVT devices created through a partnership of the STS and the ACC in close collaboration with the Food and Drug Administration, the Center for Medicare and Medicaid Services, and the Duke Clinical Research Institute. The registry will serve as an objective, comprehensive, and scientifically based resource to improve the quality of patient care, to monitor the safety and effectiveness of TVT devices, to serve as an analytic resource for TVT research, and to enhance communication among key stakeholders.
Trial registration: ClinicalTrials.gov NCT01737528.
Keywords: ACC; American College of Cardiology; CMS; Center for Medicare and Medicaid Services; FDA; Food and Drug Administration; IDE; NCD; NCDR; National Cardiovascular Data Registry; PAS; RCT; STS; Society of Thoracic Surgeons; TAVR; TVT; aortic stenosis; investigational device exemption; mitral regurgitation; national coverage decision; post-approval study; randomized clinical trial; registry; transcatheter aortic valve replacement; transcatheter valve therapy; valves.
Copyright © 2013 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.
Source: PubMed