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Stone GW, Vahanian AS, Adams DH, et al. 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. Eur Heart J. 2015;36(29):1851-77doi: 10.1093/eurheartj/ehv281.
Stone, G. W., Vahanian, A. S., Adams, D. H., Abraham, W. T., Borer, J. S., Bax, J. J., Schofer, J., Cutlip, D. E., Krucoff, M. W., Blackstone, E. H., Généreux, P., Mack, M. J., Siegel, R. J., Grayburn, P. A., Enriquez-Sarano, M., Lancellotti, P., Filippatos, G., Kappetein, A. P. (2015). 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. European heart journal, 36(29), 1851-77. https://doi.org/10.1093/eurheartj/ehv281
Stone, Gregg W, et al. "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." European heart journal vol. 36,29 (2015): 1851-77. doi: https://doi.org/10.1093/eurheartj/ehv281
Stone GW, Vahanian AS, Adams DH, Abraham WT, Borer JS, Bax JJ, Schofer J, Cutlip DE, Krucoff MW, Blackstone EH, Généreux P, Mack MJ, Siegel RJ, Grayburn PA, Enriquez-Sarano M, Lancellotti P, Filippatos G, Kappetein AP. 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. Eur Heart J. 2015 Aug 01;36(29):1851-77. doi: 10.1093/eurheartj/ehv281. Epub 2015 Jul 13. PMID: 26170467.
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Eur Heart J. 2015 Aug 01;36(29):1851-77. doi: 10.1093/eurheartj/ehv281. Epub 2015 Jul 13.

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.

European heart journal

Gregg W Stone, Alec S Vahanian, David H Adams, William T Abraham, Jeffrey S Borer, Jeroen J Bax, Joachim Schofer, Donald E Cutlip, Mitchell W Krucoff, Eugene H Blackstone, Philippe Généreux, Michael J Mack, Robert J Siegel, Paul A Grayburn, Maurice Enriquez-Sarano, Patrizio Lancellotti, Gerasimos Filippatos, Arie Pieter Kappetein,

Affiliations

  1. Columbia University Medical Center/New York-Presbyterian Hospital, New York, New York Cardiovascular Research Foundation, New York, New York [email protected].
  2. Hôpital Bichat, Paris, France.
  3. Mount Sinai Health System, New York, New York.
  4. The Ohio State University, Columbus, Ohio.
  5. SUNY Downstate Medical Center, Brooklyn, New York.
  6. Leiden University Medical Center, Leiden, the Netherlands.
  7. Hamburg University Cardiovascular Center, Hamburg, Germany.
  8. Beth Israel Deaconess Medical Center, Boston, Massachusetts.
  9. Duke University Medical Center, Durham, North Carolina.
  10. Cleveland Clinic, Cleveland, Ohio.
  11. Columbia University Medical Center/New York-Presbyterian Hospital, New York, New York Cardiovascular Research Foundation, New York, New York Hôpital du Sacré-Coeur de Montréal, Montreal, Quebec, Canada.
  12. Baylor University Medical Center, Dallas, Texas.
  13. Cedars-Sinai Medical Center, Los Angeles, California.
  14. Mayo Clinic, Rochester, Minnesota.
  15. University Hospital of Liège, Liège, Belgium.
  16. Athens University Hospital Attikon, Athens, Greece.
  17. Erasmus University Medical Center, Rotterdam, the Netherlands. For complete information on the MVARC members and participants, please see the Online Appendix.

PMID: 26170467 DOI: 10.1093/eurheartj/ehv281

Abstract

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.

Published on behalf of the European Society of Cardiology. All rights reserved. © American College of Cardiology 2015. For permissions please email: [email protected]. 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.

Keywords: Heart failure; Mitral regurgitation; Mitral valve; Valve intervention; Valve surgery (or cardiac surgery)

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