Design
Guideline
Adoption of uniform TAVI endpoints is now warranted in trials; extends consensus standards to improve outcome comparability and regulatory review.
Although consensus criteria will invariably include certain arbitrary features, an organized multidisciplinary process to develop specific definitions for TAVI clinical research should provide consistency across studies that can facilitate the evaluation of this new important catheter-based therapy. The broadly based consensus endpoint definitions described in this document may be useful for regulatory and clinical trial purposes.
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Leon et al. (2011) studied this question.
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