Pulsed Field Ablation of Persistent Atrial Fibrillation With Continuous Electrocardiographic Monitoring Follow-Up: ADVANTAGE AF Phase 2

There are sparse high-quality safety and effectiveness data for pulsed field ablation (PFA) of persistent atrial fibrillation (PerAF), in which lesions beyond pulmonary vein isolation (PVI) are often placed. In addition, no large trials have used insertable cardiac monitors for continuous rhythm monitoring after ablation in patients with PerAF or after PFA in any atrial fibrillation population. In Phase 2 of the ADVANTAGE AF study (A Prospective Single Arm Open Label Study of the FARAPULSE Pulsed Field Ablation System in Subjects With Persistent Atrial Fibrillation), patients with PerAF underwent PFA for PVI and posterior wall ablation (PWA) and, in a subcohort, cavotricuspid isthmus ablation for typical atrial flutter.

Patients with PerAF underwent PVI and posterior wall ablation with the pentaspline PFA catheter and cavotricuspid isthmus with a novel focal-linear PFA catheter after intravenous nitroglycerin prophylaxis. Patients were followed up for 1 year with continuous rhythm monitoring after ablation with insertable cardiac monitors to emulate traditional intermittent monitoring for the primary efficacy end point and to examine atrial arrhythmia (AA) burden and episode duration.