Key result
AF burden emerges as a viable alternative primary endpoint over the traditional 30-second standard.
Why the study?
Clinical trials evaluating interventions for atrial fibrillation have traditionally used a thirty second arrhythmia end point, prompting evaluation of the ascertainment, definition, analysis, and regulatory implications of atrial fibrillation burden as a primary outcome.
This Clinical Trials Workshop evaluates the ascertainment, definition, analysis, and regulatory implications of using atrial fibrillation burden as a primary endpoint in intervention trials rather than the traditional 30-second arrhythmia endpoint.
May inform endpoint selection in AF trials; leaves open validation against clinical outcomes before adoption.
AbstractAtrial fibrillation is the most common cardiac arrhythmia in the world. In clinical trials evaluating interventions for atrial fibrillation, outcomes have been traditionally defined using a thirty second arrhythmia end point. In this Clinical Trials Workshop, we evaluate the role of atrial fibrillation burden as a primary outcome for atrial fibrillation intervention trials. In particular, we evaluate key considerations for ascertainment, definition, and analysis of atrial fibrillation burden while further considering regulatory implications of its use as a primary end point.
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Andrade et al. (2026) conducted a review in Atrial fibrillation. Atrial fibrillation burden is evaluated in this workshop as an alternative to the traditional 30-second arrhythmia endpoint for primary outcomes in intervention trials.
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