Key result
Variable-loop circular PFA catheter achieves ~100% acute pulmonary vein isolation with low adverse events.
Why the study?
The safety and effectiveness of the variable loop circular catheter pulsed field ablation system in atrial fibrillation required assessment in standard clinical practice.
Does pulsed field ablation with a variable loop circular catheter achieve acute procedural success and safety in patients undergoing first-time pulmonary vein isolation for atrial fibrillation?
Observational (n=868)
Yes
Does pulsed field ablation with a variable loop circular catheter achieve acute procedural success and safety in patients undergoing first-time pulmonary vein isolation for atrial fibrillation?
Pulsed field ablation with a variable loop circular catheter demonstrates high acute procedural success (99.8%) and a low adverse event rate (0.8%) for first-time PVI in real-world practice.
BACKGROUND: The safety and effectiveness of the variable loop circular catheter (VLCC) pulsed field ablation (PFA) system was shown in atrial fibrillation (AF) registrational trials. OBJECTIVE: Assess acute safety and effectiveness of first-time pulmonary vein isolation (PVI) with the VLCC in standard clinical practice in the VARIPURE substudy of the ongoing, prospective, multicenter, observational SECURE postmarket follow-up study. METHODS: Data were extracted from Electronic Data Capture and the CARTONET data analytics software. Primary safety was the incidence of primary adverse events related to the VLCC and/or procedure. Primary effectiveness was acute procedural success, confirmed by electrical isolation of all targeted PVs. The mean ± standard deviation procedure, left atrial dwell, and fluoroscopy times were 60.1 ± 21.9, 38.0 ± 15.6, and 5.2 ± 5.6 minutes, respectively. The primary adverse event rate was 0.8%, with no stroke, cerebrovascular accident, or transient ischemic attack. No ST elevation, coronary spasm, or acute kidney injury were reported. Acute reconnection was assessed per physician preference in a subset of patients (18.5% [78/421]). Acute PVI was achieved in 99.8% of patients. Using CARTONET (868 cases), the recommended workflow of 16-28 ablations for PVI was followed in 83.1% of patients with a 4-PV anatomy. CONCLUSION: In the largest real-world VLCC yet, PFA with the VLCC exhibits favorable safety, high acute efficacy, procedural efficiency, and recommended workflow adherence. Results may provide a strong foundation for future studies of this PFA technology upon 12-month follow-up completion. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04750798 (https://clinicaltrials.gov/study/NCT04750798).
No takes yet. Share an insight, caveat, or question.
Almorad et al. (2026) conducted an observational in Atrial fibrillation (n=868). Variable loop circular catheter (VLCC) pulsed field ablation (PFA) was evaluated on Incidence of primary adverse events related to the VLCC and/or procedure, and acute procedural success (electrical isolation of all targeted PVs). First-time pulmonary vein isolation using the variable loop circular catheter pulsed field ablation system achieved 99.8% acute procedural success with a 0.8% primary adverse event rate.
Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context: