Clinical Trial Design Principles and Endpoint Definitions for Transcatheter Mitral Valve Repair and Replacement: Part 2: Endpoint Definitions A Consensus Document From the Mitral Valve Academic Research Consortium

JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY

卷:66

Article

Stone, Gregg W.^1,2  Adams, David H.³  Abraham, William T.⁴  Kappetein, Arie Pieter⁵  Genereux, Philippe^1,2,6  Vranckx, Pascal⁷  Mehran, Roxana^2,3  Kuck, Karl-Heinz⁸  Leon, Martin B.^1,2  Piazza, Nicolo⁹  Head, Stuart J.⁵  Filippatos, Gerasimos¹⁰  Vahanian, Alec S.¹¹ 

[1] Columbia Univ, Med Ctr, New York Presbyterian Hosp, New York, NY 10022 USA

[2] Cardiovasc Res Fdn, New York, NY USA

[3] Mt Sinai Hlth Syst, New York, NY USA

[4] Ohio State Univ, Columbus, OH 43210 USA

[5] Erasmus Univ, Med Ctr, Rotterdam, Netherlands

[6] Hop Sacre Coeur, Montreal, PQ H4J 1C5, Canada

[7] Hartctr Hasselt, Hasselt, Belgium

[8] Asklepios Hosp St Georg, Hamburg, Germany

[9] McGill Univ, Ctr Hlth, Montreal, PQ, Canada

[10] Univ Athens, Hosp Attikon, Athens, Greece

[11] Hop Bichat Claude Bernard, F-75877 Paris, France

关键词: heart failure;    mitral regurgitation;    mitral valve;    valve intervention;    valve surgery (or cardiac surgery);   

DOI  :  10.1016/j.jacc.2015.05.049

来源: Elsevier

【 摘 要 】

Mitral regurgitation (MR) is one of the most prevalent valve disorders and has numerous etiologies, including primary (organic) MR, due to underlying degenerative/structural mitral valve (MV) pathology, and secondary (functional) MR, which is principally caused by global or regional left ventricular remodeling and/or severe left atrial dilation. Diagnosis and optimal management of MR requires integration of valve disease and heart failure specialists, MV cardiac surgeons, interventional cardiologists with expertise in structural heart disease, and imaging experts. The introduction of transcatheter MV therapies has highlighted the need for a consensus approach to pragmatic clinical trial design and uniform endpoint definitions to evaluate outcomes in patients with MR. The Mitral Valve Academic Research Consortium is a collaboration between leading academic research organizations and physician-scientists specializing in MV disease from the United States and Europe. Three in-person meetings were held in Virginia and New York during which 44 heart failure, valve, and imaging experts, MV surgeons and interventional cardiologists, clinical trial specialists and statisticians, and representatives from the U.S. Food and Drug Administration considered all aspects of MV pathophysiology, prognosis, and therapies, culminating in a 2-part document describing consensus recommendations for clinical trial design (Part 1) and endpoint definitions (Part 2) to guide evaluation of transcatheter and surgical therapies for MR. The adoption of these recommendations will afford robustness and consistency in the comparative effectiveness evaluation of new devices and approaches to treat MR. These principles may be useful for regulatory assessment of new transcatheter MV devices, as well as for monitoring local and regional outcomes to guide quality improvement initiatives. (C) 2015 by the American College of Cardiology Foundation.

【 授权许可】

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