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.
Stone, G. W.; Vahanian, A. S.; Adams, D. H.et al.
2015 • In European Heart Journal, 36 (29), p. 1851-77
Heart failure; Mitral regurgitation; Mitral valve; Valve intervention; Valve surgery (or cardiac surgery); Mitral Valve Insufficiency; Cardiac Catheterization; Clinical Trials as Topic; Echocardiography; Heart Valve Prosthesis Implantation; Multidetector Computed Tomography; Practice Guidelines as Topic
Abstract :
[en] Mitral regurgitation (MR) is one of the most prevalent valve disorders and has numerous aetiologies, 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 remodelling 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.
Disciplines :
Cardiovascular & respiratory systems
Author, co-author :
Stone, G. W.; Columbia University Medical Center, New York-Presbyterian Hospital, Cardiovascular Research Foundation, 111 East 59th Street, New York, NY, United States, Cardiovascular Research Foundation, 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
GCrossed D Sign Crossed D Signreux, P.; Columbia University Medical Center, New York-Presbyterian Hospital, Cardiovascular Research Foundation, 111 East 59th Street, New York, NY, United States, Cardiovascular Research Foundation, New York, NY, United States, Hôpital du SacrCrossed D Sign -Coeur de MontrCrossed D Signal, 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 ; 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
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.
Publication date :
2015
Journal title :
European Heart Journal
ISSN :
0195-668X
eISSN :
1522-9645
Publisher :
Oxford University Press, United Kingdom
Volume :
36
Issue :
29
Pages :
1851-77
Peer reviewed :
Peer Reviewed verified by ORBi
Commentary :
Published on behalf of the European Society of Cardiology. All rights reserved. (c) American College of Cardiology 2015. For permissions please email: journals.permissions@oup.com. This article is being published concurrently in Journal of the American College of Cardiology [1]. The articles are identical except for minor stylistic and spelling differences in keeping with each journal's style. Either citation can be used when citing this article. [1] Stone GW, Vahanian AS, Adams DH, Abraham WT, Borer JS et al. Clinical trial design principles and endpoint definitions for transcatheter mitral valve repair and replacement: Part 1: Clinical Trial Design Principles. J Am Coll Cardiol 2015;66:278-307. doi: 10.1016/j.jacc.2015.05.046.
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