A randomized controlled trial of pulsed field ablation versus standard-of-care ablation for paroxysmal atrial fibrillation: The ADVENT trial rationale and design

Vivek Y Reddy; John W Lehmann; Edward P Gerstenfeld; Andrew S Mugglin; Christopher W Schneider; Anitha B Achyutha; Moussa Mansour

doi:10.1016/j.hroo.2023.03.001

A randomized controlled trial of pulsed field ablation versus standard-of-care ablation for paroxysmal atrial fibrillation: The ADVENT trial rationale and design

Heart Rhythm O2. 2023 Mar 8;4(5):317-328. doi: 10.1016/j.hroo.2023.03.001. eCollection 2023 May.

Authors

Vivek Y Reddy¹, John W Lehmann², Edward P Gerstenfeld³, Andrew S Mugglin⁴, Christopher W Schneider⁵, Anitha B Achyutha⁵, Moussa Mansour⁶

Affiliations

¹ Helmsely Electrophysiology Center, Icahn School of Medicine at Mount Sinai, New York City, New York.
² Lehmann Consulting, Naples, Florida.
³ Section of Cardiac Electrophysiology, Division of Cardiology, University of California, San Francisco, San Francisco, California.
⁴ Paradigm Biostatistics LLC, Anoka, Minnesota.
⁵ Electrophysiology, Boston Scientific Corporation, Menlo Park, California.
⁶ Corrigan Minehan Heart Center, Massachusetts General Hospital, Boston, Massachusetts.

Abstract

Background: Pulmonary vein isolation (PVI) is an effective treatment for paroxysmal atrial fibrillation (PAF). However, potential complications can occur due to the propagation of thermal energy into nontarget tissues adjacent to the targeted myocardium. Pulsed field ablation (PFA) is a novel ablation modality with the potential for preferential myocardial tissue ablation to minimize damage to collateral cardiac structures. A multielectrode pentaspline catheter has demonstrated safety and efficacy in treating PAF in single-arm, first-in-human studies.

Objective: The study sought to perform a randomized clinical trial to directly compare this PFA catheter with conventional ablation-either radiofrequency or cryoballoon ablation.

Methods: The ADVENT (Randomized Controlled Trial for Pulsed Field Ablation versus Standard of Care Ablation for Paroxysmal Atrial Fibrillation) trial is a multicenter, prospective, single-blind, randomized controlled trial to compare PVI using PFA vs conventional thermal ablation for drug-resistant PAF-with each site employing either (but not both) cryoballoon or radiofrequency ablation as a control condition. The sample size is adaptively determined based on Bayesian statistical methods. All patients will undergo PVI, and be followed for 12 months.

Results: The primary effectiveness endpoint is a composite of acute procedural success and freedom from any documented atrial arrhythmia recurrence, repeat ablation, or use of antiarrhythmic drugs after a 3-month postablation blanking period. The primary safety endpoint is a composite of defined acute and chronic device- and procedure-related serious adverse events. Both primary endpoints will be evaluated for noninferiority of the novel PFA system compared with standard-of-care thermal ablation.

Conclusions: By providing objective, comparative data, this study aims to scientifically determine whether the pentaspline PFA catheter is safe and effective for PVI ablation to treat drug-resistant PAF.

Keywords: Atrial fibrillation; Catheter ablation; Pulmonary vein isolation; Pulsed field ablation; Randomized controlled trial.