Efficacy and safety of a novel pulsed field ablation system in paroxysmal atrial fibrillation.

BACKGROUND

Pulsed field ablation (PFA) is an emerging innovative technology for treating paroxysmal atrial fibrillation (PAF), featured by its superior speed, accuracy, and reduced risk to adjacent tissues. The NOVA-AF study aimed to evaluate the efficacy and safety of a novel PFA system equipped with two PFA catheters: a circular PFA catheter and a linear PFA catheter integrating contact force-sensing capability, in patients with symptomatic PAF.

METHODS

This prospective, multicenter, single-arm study enrolled 161 patients with symptomatic PAF from seven medical centers in China. The composite primary effectiveness endpoint was defined as freedom from atrial tachyarrhythmia recurrence, device failure, multiple ablations during the blanking period, or antiarrhythmic drug failure during the evaluation period. The primary safety endpoint was the incidence of major adverse events (MAEs) related to the devices or procedures within three months of the procedure.

RESULTS

All the ablated lesions (100%) were acutely electrically isolated. No patients underwent repeat ablation during the 90-day blanking period. The 12-month Kaplan–Meier estimates for primary effectiveness success and clinical success (absence of symptomatic atrial fibrillation recurrence) were 83.0% (95% confidence interval, 76.2%–88.0%) and 94.9%, respectively. No MAEs occurred.

CONCLUSION

This novel PFA system is effective and safe for the ablation treatment of patients with symptomatic PAF. REGISTRY: Chinese Clinical Trial Registry ( www.chictr.org.cn ), TRN: ChiCTR2400091941, Registration date: Nov 6 2024 (retrospectively registered).