Catheter ablation of atrial fibrillation using the pulsed-field energy; a prospective randomized comparison of the CENTAURI PEF system and the FARAPULSE System
Z Starek, F Soucek, K Dolezalova, M Pesl, V Sebetovsky, J HejcAbstract
Introduction
Radiofrequency (RF) catheter ablation has been the standard treatment for atrial fibrillation (AF). However, irreversible electroporation (pulse field ablation, PFA) is emerging as a promising alternative. The aim of this study is to present one-year results comparing the efficacy and safety of catheter ablation for AF using the point-to-point CENTAURI PEF System and the single-shot FARAPULSE System.
Methods
Patients referred for ablation of paroxysmal and persistent AF were enrolled in this study and randomly assigned to one of two groups. The CENTAURI PEF group (CENT) underwent ablation with the EnSite Precision 3D mapping system for left atrial mapping, TactiCath CF ablation catheter for point-to-point ablation using PFA generated by the CENTAURI PEF generator. The FARAPULSE group (FARA) underwent ablation with a specialized single-shot multipolar basket catheter under fluoroscopy and intracardiac ultrasound guidance. All procedures were performed under general anesthesia. Periprocedural parameters and follow-up results were compared between the two groups.
Results
Between 5th January 2024 and 30th September 2025 a total of 320 patients underwent catheter ablation for AF (177 with paroxysmal AF and 143 with persistent AF). 155 patients were treated with the CENTAURI system and 165 with the FARAPULSE system. The baseline characteristics of those two groups were similar: 27% and 34% of patients were women resp., the mean age was 64 and 64 years resp., the mean left atrial size was 46 and 46 mm. The average total procedure time was 133,5 min for the CENT and 81 min for the FARA. The X-ray dose was 1500 mGy·cm² for the CENT and 2550 mGy·cm² for the FARA. The isolation time of the left pulmonary veins (LPVs) was 17 min for the CENT and 8 min for the FARA. The isolation time of the right pulmonary veins (RPVs) was 19 min for the CENTand 8 min for the FARA. Acute or subacute complications were not recorded in the CENT, while in the FARA was one stroke and one pericardial effusion requiring pericardiocentesis. A total of 101 patients from the CENT attended a follow-up visit at 12 months, 72% of patients maintained sinus rhythm.105 patients from the FARA underwent a 12-month follow-up visit and 74% of patients maintained sinus rhythm. The results for ablation of both paroxysmal and persistent AF were similar for the two groups.
Conclusions
Catheter ablation with both PFA systems appears to be comparably effective and safe. The complications observed in the FARAPULSE group are typical of those associated with catheter ablation of arrhythmias and may be attributed to the learning curve. Procedure times were longer with the CENTAURI system, primarily due to 3D mapping and point-by-point ablation, while the FARAPULSE system resulted in a shorter procedure time but a significantly higher X-ray dose. Long-term efficacy is similar, but folow up is not yet finished.