title: The STS-ACC transcatheter valve therapy national registry: a new partnership and infrastructure for the introduction and surveillance of medical devices and therapies.
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.
authors: University of Colorado School of Medicine, Aurora, Colorado, USA. john.carroll@ucdenver.edu
authors: John D
authors: JD
authors: Carroll
authors: Fred H
authors: FH
authors: Edwards
authors: Danica
authors: D
authors: Marinac-Dabic
authors: Ralph G
authors: RG
authors: Brindis
authors: Frederick L
authors: FL
authors: Grover
authors: Eric D
authors: ED
authors: Peterson
authors: E Murat
authors: EM
authors: Tuzcu
authors: David M
authors: DM
authors: Shahian
authors: John S
authors: JS
authors: Rumsfeld
authors: Cynthia M
authors: CM
authors: Shewan
authors: Kathleen
authors: K
authors: Hewitt
authors: David R
authors: DR
authors: Holmes
authors: Michael J
authors: MJ
authors: Mack
mesh_terms: D006328:Cardiac Catheterization; D002309:Cardiology; D014487:Centers for Medicare and Medicaid Services, U.S.; D003625:Data Collection; D019918:Heart Valve Prosthesis Implantation / Q000009:adverse effects / Q000379:methods / Q000592:standards*; D006801:Humans; D018579:Patient Selection; D011358:Product Surveillance, Postmarketing / Q000191:economics; D012042:Registries; D012952:Societies; D013903:Thoracic Surgery; D014481:United States; D014486:United States Food and Drug Administration
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