STS-ACC 经导管瓣膜治疗国家注册登记研究：医疗器械和疗法引入及监测的新合作关系和基础设施。

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

机构信息

University of Colorado School of Medicine, Aurora, Colorado, USA.

出版信息

J Am Coll Cardiol. 2013 Sep 10;62(11):1026-34. doi: 10.1016/j.jacc.2013.03.060. Epub 2013 May 1.

DOI:10.1016/j.jacc.2013.03.060

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.

摘要

胸外科医师学会（STS）和美国心脏病学会（ACC）经导管瓣膜治疗（TVT）注册中心是一个新的全国性注册中心，涵盖了所有通过 STS 和 ACC 合作、与食品和药物管理局、医疗保险和医疗补助服务中心以及杜克临床研究所密切合作创建的新型 TVT 设备。该注册中心将作为一个客观、全面和科学的资源，用于提高患者护理质量，监测 TVT 设备的安全性和有效性，为 TVT 研究提供分析资源，并加强关键利益相关者之间的沟通。