The ADVENT trial, published in the New England Journal of Medicine in 2023, was a randomized, single-blind, noninferiority trial designed to compare the safety and efficacy of pulsed field ablation with conventional thermal ablation techniques (radiofrequency or cryoballoon) for the treatment of symptomatic paroxysmal atrial fibrillation (pAF).
The trial included 607 patients who were 18 to 75 years old with symptomatic paroxysmal AF and had experienced at least one treatment failure with an antiarrhythmic drug. Participants were randomized to receive either pulsed field ablation (n=305) or conventional thermal ablation (n=302).
The primary outcome focused on freedom from initial procedural failure, documented atrial tachyarrhythmia after a 3-month blanking period, antiarrhythmic drug use, cardiovascular hospitalization, or repeat ablation. The results showed a high percentage of freedom from these events in both the pulsed field ablation group (73.3%) and the thermal ablation group (71.3%), with a p-value for noninferiority greater than 0.99.
Secondary outcomes included the rate of device- and procedure-related serious adverse events and the mean change in pulmonary vein cross-sectional area. The incidence of serious adverse events was low in both groups, with 2.1% in the pulsed field group and 1.5% in the thermal group, again with a p-value for noninferiority greater than 0.999. The mean change in pulmonary vein cross-sectional area was minor, with -0.18 cm² in the pulsed field group and -1.18 cm² in the thermal group.
The conclusion of the ADVENT trial was that among patients with pAF receiving catheter-based therapy, pulsed field ablation was noninferior to conventional thermal ablation in terms of freedom from a composite of initial procedural failure, documented atrial tachyarrhythmia after a 3-month blanking period, antiarrhythmic drug use, cardiovascular intervention, or repeat ablation, with respect to device- and procedure-related serious adverse events at 1 year.
These results support the use of pulsed field ablation as a safe and effective alternative to conventional thermal ablation techniques for patients with paroxysmal atrial fibrillation, providing an additional option for cardiologists in the management of this arrhythmia.