The STS-ACC transcatheter valve therapy national registry: a new partnership and infrastructure for the introduction and surveillance of medical devices and therapies.-临床诊疗知识库

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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.

作者：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；Michael J, Mack

来源：Journal of the American College of Cardiology 2013 年 62卷 11期

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The STS-ACC transcatheter valve therapy national registry: a new partnership and infrastructure for the introduction and surveillance of medical devices and therapies.

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作者：

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；Michael J, Mack

来源：

Journal of the American College of Cardiology 2013 年 62卷 11期

标签：

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

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