@article{95e24cc94ad74f64875e3561879a72ec,
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.",
keywords = "aortic stenosis, mitral regurgitation, registry, valves",
author = "Carroll, {John D.} and Edwards, {Fred H.} and Danica Marinac-Dabic and Brindis, {Ralph G.} and Grover, {Frederick L.} and Peterson, {Eric D.} and Tuzcu, {E. Murat} and Shahian, {David M.} and Rumsfeld, {John S.} and Shewan, {Cynthia M.} and Kathleen Hewitt and Holmes, {David R.} and Mack, {Michael J.}",
note = "Funding Information: Dr. Carroll is an investigator for the PARTNER II clinical trial sponsored by Edwards Lifesciences; and a consultant to the Steering Committee of the RESPECT trial of St. Jude Medical. Dr. Marinac-Dabic is director of the Division of Epidemiology, Food and Drug Administration. Dr. Peterson receives research support from Eli Lilly, Janssen Pharmaceuticals, Pfizer, and Boehringer Ingleheim . Dr. Rumsfeld is chief science officer for the National Cardiovascular Data Registry. Dr. Shewan is a co-investigator for the ASCERT study. Dr. Mack is an uncompensated member of the executive committee of the PARTNER trial with travel expenses paid for by Edwards Lifesciences. All other authors have reported they have no relationships relevant to the contents of this paper to disclose. Funding Information: The investment to enable the creation of the TVT registry began 2 decades ago as STS and ACC founded their respective national clinical databases. The development of the TVT registry has been funded by STS and ACC. The on-going funding must maintain the independence of the governance and day-to-day activities of the registry. ",
year = "2013",
month = sep,
day = "10",
doi = "10.1016/j.jacc.2013.03.060",
language = "English (US)",
volume = "62",
pages = "1026--1034",
journal = "Journal of the American College of Cardiology",
issn = "0735-1097",
publisher = "Elsevier USA",
number = "11",
}