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.

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Publication Details

Journal
Circulation Arrhythmia and Electrophysiology
Published
2026-09-29
DOI
https://doi.org/10.1161/circep.126.015082
Primary Topic
Atrial Fibrillation Management and Outcomes
Type
article
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article

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

Stylianos E. Tzeis, A. John Camm, Elaine Y. Wan, ROD S. PASSMAN et al.
Circulation Arrhythmia and Electrophysiology
Atrial Fibrillation Management and Outcomes
article

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

Stylianos E. Tzeis, A. John Camm, Elaine Y. Wan, ROD S. PASSMAN, Jonathan Paul Piccini, Kevin L. Thomas, Carina Blomström‐Lundqvist, Hugh G Calkins, Mellanie True Hills, Boris Schmidt, Atul Verma, Thomas Jared Bunch, J. Peter Weiss, Paul J. Wang, Pierre Jaı̈s, Marco Valentin Perez, Edward P. Gerstenfeld, Jason G. Andrade, Mina K. Chung, Lin Y. Chen, Andrea M. Russo, Matthew R. Reynolds, Eileen Mihas
article en

Abstract

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.

Circulation Arrhythmia and Electrophysiology
Northwestern University (US), Hôpital américain de paris (FR), Lahey Hospital and Medical Center (US), UMass Memorial Health Care (US), Cleveland Clinic (US), Johns Hopkins University (US), St George's, University of London (GB), University of Massachusetts Chan Medical School (US), Duke University (US), Örebro University (SE), Johns Hopkins Medicine (US), McGill University Health Centre (CA), Vancouver General Hospital (CA), Cardiovascular Center Bethanien (DE), Cooper Medical School of Rowan University (US), Banner - University Medical Center Phoenix (US), Hygeia Hospital (GR), Duke Medical Center (US), Minneapolis Heart Institute Foundation (US), San Diego Cardiac Center (US), The Medical Device (United Kingdom) (GB), McGill University (CA), Columbia University (US), Stanford University (US)
Openalex Percentile: Top 11%
Atrial Fibrillation Management and Outcomes
DOISourceOpenAlex
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