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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 ,  Journal Article
Stone, GW; Vahanian, AS; Adams, DH; Abraham, WT; Borer, JS; Bax, JJ; Schofer, J; Cutlip, DE; Krucoff, MW; Blackstone, EH; Généreux, P ...
Published in: J Am Coll Cardiol
July 21, 2015

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.

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Published In

J Am Coll Cardiol

DOI

EISSN

1558-3597

Publication Date

July 21, 2015

Volume

66

Issue

3

Start / End Page

278 / 307

Location

United States

Related Subject Headings

  • Ventricular Remodeling
  • United States
  • Risk Assessment
  • Research Design
  • Prognosis
  • Patient Selection
  • Mitral Valve Insufficiency
  • Mitral Valve
  • Humans
  • Heart Valve Prosthesis Implantation
 

Citation

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Stone, G. W., Vahanian, A. S., Adams, D. H., Abraham, W. T., Borer, J. S., Bax, J. J., … Mitral Valve Academic Research Consortium (MVARC), . (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. J Am Coll Cardiol, 66(3), 278–307. https://doi.org/10.1016/j.jacc.2015.05.046
Stone, Gregg W., Alec S. Vahanian, David H. Adams, William T. Abraham, Jeffrey S. Borer, Jeroen J. Bax, Joachim Schofer, 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.J Am Coll Cardiol 66, no. 3 (July 21, 2015): 278–307. https://doi.org/10.1016/j.jacc.2015.05.046.
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, Mitral Valve Academic Research Consortium (MVARC). 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. J Am Coll Cardiol. 2015 Jul 21;66(3):278–307.
Journal cover image

Published In

J Am Coll Cardiol

DOI

EISSN

1558-3597

Publication Date

July 21, 2015

Volume

66

Issue

3

Start / End Page

278 / 307

Location

United States

Related Subject Headings

  • Ventricular Remodeling
  • United States
  • Risk Assessment
  • Research Design
  • Prognosis
  • Patient Selection
  • Mitral Valve Insufficiency
  • Mitral Valve
  • Humans
  • Heart Valve Prosthesis Implantation