Atrial Fibrillation Ablation Effectiveness End Points, Safety End Points, and Trial Design: Academic Research Consortium Initiative Endorsed by the Heart Rhythm Society

The aim of the AFA-ARC (Atrial Fibrillation Ablation Academic Research Consortium) initiative is to reexamine trial design and the safety and effectiveness end points for pivotal clinical trials evaluating catheter ablation for the treatment of symptomatic atrial fibrillation to provide meaningful and interpretable data to support regulatory decision-making. Beginning in July 2024, a group of international experts began meeting regularly both virtually together and separately in working groups (group 1 effectiveness end points; group 2 safety end points; and group 3 trial design and report forms), with one in-person meeting held in April 2025, and revisions of draft proposals from January 2025 to February 2026. The Food and Drug Administration Office of Cardiovascular Devices at the Center for Devices and Radiological Health provided input throughout the revision and proposal process. A patient advocate participated in the in-person meeting and during the revision phase. Heart Rhythm Society leadership was involved throughout the process and in the revision phase. Industry representatives were sent drafts of the proposed manuscripts during the revision phase before submission. The result of this process was the creation of a combined document to reexamine trial design and the safety and effectiveness end points for pivotal clinical trials evaluating catheter ablation of atrial fibrillation. This document represents contributions from each of the 3 Working Groups. The Heart Rhythm Society endorsed this document. This AFA-ARC document proposes revised effectiveness and safety end points, study design, and report forms for studies evaluating AF ablation in patients with symptomatic paroxysmal, persistent, or longstanding persistent AF.