Acute Procedural Results of Pulsed Field Cryoablation for Persistent Atrial Fibrillation: Multicenter First‐in‐Human PARALELL Trial

• DOI: 10.1111/jce.16680
• Publication Date: 2025-04-16T12:14:36Z
• Authors: Vidal Essebag; Lucas Boersma; Jan Petru; Mark M. Gallagher; Vivek Y. Reddy; Tom De Potter; Pawel Derejko; Petr Neuzil; Ilya Grigorov; Atul Verma
• Keywords: Cryoablation; Cryosurgery

ABSTRACT Introduction Pulsed Field Cryoablation (PFCA) is a dual‐energy cardiac ablation modality consisting of short‐duration ultra‐low temperature cryoablation (ULTC) followed immediately by pulsed field (PFA) delivered from the same catheter. It hypothesized that PFCA may improve contact stability during PFA, while maintaining lesion depth and effectiveness ULTC. Methods PARALELL first‐in‐human multicenter study evaluating safety novel catheter system in patients with persistent atrial fibrillation (PsAF) using combination pulmonary vein (PVI) posterior wall (PWI) isolation. Results Sixty‐six were ablated at six sites. One groin hematoma one intubation‐related hospitalization only serious procedure‐ or device‐related adverse events recorded study. Per protocol, acute was evaluated 46 patients, including 31 post‐hoc analysis cryogenic energy per lesion. After an average 21.1 ± 9.3 lesions patient rates PVI PWI 95.7% (176/184) 97.7% (42/43), respectively. The highly predictive isolation success ROC AUC = 0.944% 100% both 24 optimal cohort. Grade I microbubbles faint muscle contractions detected 1.1% 0.5% ablations, Conclusion This initial multi‐center experience suggests can be efficiently performed for single versatile system, high good early profile. evaluation chronic 12‐month ongoing.