Mitral Valve Academic Research Consortium consensus report: the U.S. Food and Drug Administration perspective.
نویسندگان
چکیده
This editorial refers to ‘Clinical trial design principles and endpoint definitions for transcatheter mitral valve repair and replacement: part 1: clinical trial design principles’, by G.W. Stone et al., on page 1851 and ‘Clinical trial design principles and endpoint definitions for transcatheter mitral valve repair and replacement: part 2: endpoint definitions’, by G.W. Stone et al., on page 1878.
منابع مشابه
Standardized endpoint definitions for transcatheter aortic valve implantation clinical trials: a consensus report from the Valve Academic Research Consortium†
OBJECTIVES To propose standardized consensus definitions for important clinical endpoints in transcatheter aortic valve implantation (TAVI), investigations in an effort to improve the quality of clinical research and to enable meaningful comparisons between clinical trials. To make these consensus definitions accessible to all stakeholders in TAVI clinical research through a peer reviewed publi...
متن کاملClinical End Points in Coronary Stent Trials
Background—Although most clinical trials of coronary stents have measured nominally identical safety and effectiveness end points, differences in definitions and timing of assessment have created confusion in interpretation. Methods and Results—The Academic Research Consortium is an informal collaboration between academic research organizations in the United States and Europe. Two meetings, in ...
متن کاملProsthetic valve endocarditis caused by multidrug-resistant Candida albicans in a patient with myelodysplasia syndrome: A case report and literature review
Background and Purpose: Candida endocarditis is an infrequent disease with a high mortality rate, which commonly occurs in immunosuppressed patients with cardiac valve replacement. We reported a 70-year-old woman diagnosed with Candida prosthetic valve endocarditis (PVE). This study also involved a review of all published cases of Candida PVE from 1970. Case report: Herein, we reported a 70-ye...
متن کاملUpdated standardized endpoint definitions for transcatheter aortic valve implantation: the Valve Academic Research Consortium-2 consensus document (VARC-2).
OBJECTIVES The aim of the current Valve Academic Research Consortium (VARC)-2 initiative was to revisit the selection and definitions of transcatheter aortic valve implantation (TAVI) clinical endpoints to make them more suitable to the present and future needs of clinical trials. In addition, this document is intended to expand the understanding of patient risk stratification and case selectio...
متن کاملClinical end points in coronary stent trials: a case for standardized definitions.
BACKGROUND Although most clinical trials of coronary stents have measured nominally identical safety and effectiveness end points, differences in definitions and timing of assessment have created confusion in interpretation. METHODS AND RESULTS The Academic Research Consortium is an informal collaboration between academic research organizations in the United States and Europe. Two meetings, i...
متن کاملذخیره در منابع من
با ذخیره ی این منبع در منابع من، دسترسی به آن را برای استفاده های بعدی آسان تر کنید
عنوان ژورنال:
- European heart journal
دوره 36 29 شماره
صفحات -
تاریخ انتشار 2015