Comparative Analysis of Real-World Clinical Outcomes of a Novel Pulsed Field Ablation System for Pulmonary Vein Isolation: The Prospective CIRCLE-PVI Study

<b>Background:</b> Pulsed field ablation (PFA) represents a novel non-thermal approach for treating atrial fibrillation (AF) through pulmonary vein isolation (PVI). By utilizing irreversible electroporation, PFA creates lesions with minimal impact on adjacent tissues. This study investigates the procedural outcomes and safety of a novel circular PFA catheter in comparison to an established PFA system in a real-world clinical setting. <b>Methods</b>: This prospective, single-center study enrolled 125 consecutive patients with symptomatic paroxysmal or persistent AF undergoing first-time PVI with PFA at Ulm University Heart Center. Twenty-five patients underwent PFA PVI using a novel PFA system (PulseSelect^TM, Medtronic, Dublin, Ireland) which incorporates a new circular catheter design and additional features such as ECG-triggered energy application and phrenic nerve capture testing. In comparison, 100 patients were treated using the established PFA system (Farapulse^TM, Boston Scientific, Marlborough, MA, USA). <b>Results</b>: Acute PVI was achieved in 100% of the patients. Procedure duration, total left atrial (LA) time and fluoroscopy time remained comparable between both groups. The total number of energy deliveries was higher with the novel circular PFA catheter (34.0 vs. 32.0; <i>p</i> < 0.001). No procedure-related complications, including pericardial tamponade, phrenic nerve injury, atrial-esophageal fistula, vascular complications, embolisms, malignant cardiac arrhythmias, or coronary spasms were observed. <b>Conclusions</b>: The novel and the established PFA systems demonstrated comparable results in terms of procedure duration, fluoroscopy time, and LA time. In the hands of experienced operators, the novel circular PFA system enables an effective, consistent, and safe approach to successful PFA PVI.