Reference : Clinical Trial Design Principles and Endpoint Definitions for Transcatheter Mitral Va...
Scientific journals : Article
Human health sciences : Cardiovascular & respiratory systems
http://hdl.handle.net/2268/220265
Clinical Trial Design Principles and Endpoint Definitions for Transcatheter Mitral Valve Repair and Replacement: Part 1: Clinical Trial Design Principles A Consensus Document from the Mitral Valve Academic Research Consortium
English
Stone, G. W. [Columbia University Medical Center, New York-Presbyterian Hospital, New York, NY, United States, Columbia University Medical Center, Cardiovascular Research Foundation, 111 East 59th Street, New York, NY, United States]
Vahanian, A. S. [Hôpital Bichat, Paris, France]
Adams, D. H. [Mount Sinai Health System, New York, NY, United States]
Abraham, W. T. [Ohio State University, Columbus, OH, United States]
Borer, J. S. [SUNY Downstate Medical Center, Brooklyn, NY, United States]
Bax, J. J. [Leiden University Medical Center, Leiden, Netherlands]
Schofer, J. [Hamburg University Cardiovascular Center, Hamburg, Germany]
Cutlip, D. E. [Beth Israel Deaconess Medical Center, Boston, MA, United States]
Krucoff, M. W. [Duke University Medical Center, Durham, NC, United States]
Blackstone, E. H. [Cleveland Clinic, Cleveland, OH, United States]
Généreux, P. [Columbia University Medical Center, New York-Presbyterian Hospital, New York, NY, United States, Columbia University Medical Center, Cardiovascular Research Foundation, 111 East 59th Street, New York, NY, United States, Hôpital du Sacré-Coeur de Montréal, Montreal, QC, Canada]
Mack, M. J. [Baylor University Medical Center, Dallas, TX, United States]
Siegel, R. J. [Cedars-Sinai Medical Center, Los Angeles, CA, United States]
Grayburn, P. A. [Baylor University Medical Center, Dallas, TX, United States]
Enriquez-Sarano, M. [Mayo Clinic, Rochester, MN, United States]
Lancellotti, Patrizio mailto [Université de Liège - ULiège > Département des sciences cliniques > Imagerie cardiaque fonctionnelle par échographie >]
Filippatos, G. [Athens University Hospital Attikon, Athens, Greece]
Kappetein, A. P. [Erasmus University Medical Center, Rotterdam, Netherlands]
2015
Journal of the American College of Cardiology
Elsevier USA
66
3
278-307
Yes (verified by ORBi)
International
0735-1097
1558-3597
[en] Article ; Europe ; Mitral Valve Insufficiency ; United States ; Cardiac Catheterization ; Clinical Trials as Topic ; Disease Management ; Echocardiography ; Endpoint Determination ; Europe ; Heart Valve Prosthesis Implantation ; Humans ; Mitral Valve ; Mitral Valve Insufficiency ; Patient Selection ; Prognosis ; Research Design ; Risk Assessment ; United States ; Ventricular Remodeling
[en] 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. © 2015 American College of Cardiology Foundation.
http://hdl.handle.net/2268/220265
10.1016/j.jacc.2015.05.046

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