Index ablation for atrial fibrillation using the novel variable-loop circular catheter achieved 99.6% acute effectiveness with no device-related serious adverse events.
Observational (n=464)
Yes
Does the novel PFA variable-loop circular catheter provide acute safety and effectiveness in patients undergoing index ablation for atrial fibrillation?
The use of a novel pulsed-field ablation variable-loop circular catheter for index atrial fibrillation ablation demonstrated 99.6% acute effectiveness with no serious adverse events in a real-world multicenter European cohort.
Abstract Background Recent pulsed-field ablation (PFA) technologies have demonstrated safety and efficacy in protocol-defined trials. However, unique insights beyond pre-market trials on the use of the new variable-loop circular catheter (VLCC) are needed. Purpose Assess acute safety, effectiveness, and procedural characteristics of index ablation procedures for atrial fibrillation (AF) performed with early clinical adoption of the PFA VLCC catheter. Methods From April 2024-February 2025, patients undergoing an ablation procedure with the VLCC from 16 European centres were enrolled in a prospective, observational post-market clinical trial. Safety and acute effectiveness (entrance block confirmation of all targeted PVs with the VLCC) were evaluated. Procedural findings such as ST modifications, coronary spasm, and vagal reactions were assessed. Procedural characteristics including procedure time, pre-ablation mapping time, left atrial (LA) dwell time, fluoroscopy time were collected and workflow parameters including total complete ablations, ablation duration and complete PF energy delivery time, were derived and analysed using an artificial intelligence-powered cloud-based data management system. Results A total of 464 consecutive AF patients (61.0% male, 64.7±10.7 yrs, CHA2DS2-VASc 2.3±1.6) underwent an index ablation procedure performed with the VLCC. Approximately 61.9% of patients were treated for paroxysmal atrial fibrillation (PAF), 34.1% for persistent atrial fibrillation (PsAF), and 4.1% for long-standing PsAF, under general anaesthesia (83.0%), or conscious sedation (17.0%) (Tables 1A, 1B). Most ablations were PVI only (69.6%). Ablations outside the PVs were performed at the LA posterior wall (17.7%), LA roof (11.0%), and cavotricuspid isthmus (CTI) line (8.8%, Figure 1). No serious adverse events related to the VLCC, or neurovascular events were reported. Acute effectiveness was 99.6% (462/464). No ST modifications or coronary spasms were observed, vagal responses were observed in 14.9% of procedures. Vagal responses as described by the operator were AV block, bradycardia, and/or asystole in 14.5%, 42.0%, and 50.7% respectively. Preventive measures were taken in 49.6% of the procedures, with the majority using atropine (87.4%) or pacing (via catheter or implanted devices, 28.7%). Procedure, pre-ablation mapping, LA dwell, and fluoroscopy times were 62.7±22.6, 7.2±7.1, 38.5±17.4, and 4.8±5.3 min, respectively. Reported workflow parameters included 21.9±6.2 total complete ablations, 29.6±14.3 min ablation time, and 15.9±4.5 s valid PF energy delivery time. In 16.2% of the procedures, an additional mapping catheter was used. A total of 112 (24.1%) of cases were same-day discharge. Conclusion Initial AF ablation with the VLCC in real-world clinical practice seems safe, effective, and efficient. Further enrolment and long-term follow-up are needed to assess the clinical outcomes using this novel PFA technology.Table1
Almorad et al. (2025) conducted an observational in Atrial fibrillation (n=464). Variable-loop circular catheter (VLCC) for pulsed-field ablation was evaluated on Acute effectiveness (entrance block confirmation of all targeted PVs) and safety. Index ablation for atrial fibrillation using the novel variable-loop circular catheter achieved 99.6% acute effectiveness with no device-related serious adverse events.