March 8, 2023Open Access
A randomized controlled trial of pulsed field ablation versus standard-of-care ablation for paroxysmal atrial fibrillation: The ADVENT trial rationale and design
Structured PICO
Does pulsed field ablation using a pentaspline catheter improve outcomes compared to conventional thermal ablation in patients with drug-resistant paroxysmal atrial fibrillation?
P
Population
Patients with drug-resistant paroxysmal atrial fibrillation (PAF)
I
Intervention
Pulmonary vein isolation (PVI) using pulsed field ablation (PFA) with a multielectrode pentaspline catheter
C
Comparator
Conventional thermal ablation (either cryoballoon or radiofrequency ablation)
O
Outcome
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 periodcomposite
The ADVENT trial is designed to evaluate the safety and efficacy of a novel pulsed field ablation system compared to standard-of-care thermal ablation for drug-resistant paroxysmal atrial fibrillation.
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.