Why the study?
The introduction of transcatheter mitral valve therapies highlighted the need for a consensus approach to pragmatic clinical trial design and uniform endpoint definitions to evaluate outcomes in patients with MR.
This consensus document provides standardized endpoint definitions for clinical trials evaluating transcatheter mitral valve therapies to ensure robustness and consistency in comparative effectiveness evaluations.
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Supports consistent MR trial interpretation in practice; extends standardized endpoints across transcatheter device evaluations and regulatory review.
Stone et al. (2015) conducted a review in Mitral regurgitation. Transcatheter mitral valve repair and replacement was evaluated. The Mitral Valve Academic Research Consortium developed consensus recommendations for clinical trial design and uniform endpoint definitions to evaluate therapies for mitral regurgitation.
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