Atrial Fibrillation Burden as an Outcome in Clinical Trials

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.