This article was originally published in The Gray Sheet
Executive SummaryFDA issues 1guidance Aug. 5 on how to design clinical studies for atrial flutter ablation. Early PMA applications for catheter ablation systems to treat atrial flutter relied on single-arm trials, but FDA recommends future submissions use randomized, controlled trials. The agency will consider alternative designs, but the burden of proof will be greater in those instances. The primary effectiveness endpoint should be chronic success, defined as the absence of recurrent atrial flutter after six months, or a surrogate endpoint of acute procedural success in appropriate cases. The primary safety endpoint should be a composite of serious adverse events after seven days
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