A randomized controlled trial of pulsed field ablation versus standard-of-care ablation for paroxysmal atrial fibrillation: The ADVENT trial rationale and design
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…
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Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design.
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