Key result
Pulsed-field ablation matches RF ablation for 2-year AF control with ~40-minute shorter procedure times.
Why the study?
Pulsed field ablation is emerging as a promising alternative to radiofrequency catheter ablation for AF, motivating a two-year comparison of efficacy and safety using the CENTAURI PEF system versus standard radiofrequency ablation.
Does point-to-point pulsed field ablation using the CENTAURI PEF system improve procedural efficiency, safety, and two-year sinus rhythm maintenance compared to standard radiofrequency ablation in patients with paroxysmal and persistent atrial fibrillation?
RCT (n=236)
Randomly assigned
Does point-to-point pulsed field ablation using the CENTAURI PEF system improve procedural efficiency, safety, and two-year sinus rhythm maintenance compared to standard radiofrequency ablation in patients with paroxysmal and persistent atrial fibrillation?
Point-to-point pulsed field ablation using the CENTAURI PEF system combined with standard 3D mapping achieves shorter procedure and energy application times and higher first-pass pulmonary vein isolation rates than standard radiofrequency ablation, with comparable safety and 24-month sinus rhythm maintenance.
Shorter procedures with comparable 24-month sinus rhythm maintenance; extends RCT evidence for pulsed-field ablation as an efficient alternative to radiofrequency in AF.
Introduction Radiofrequency (RF) catheter ablation has been the most effective method for treating od the atrial fibrillation (AF). Pulse field ablation (PFA) is emerging as a promising alternative. The aim of this study is to present the two-years outcomes of the comparison of efficacy and safety of the catheter ablation for AF using the CENTAURI PEF system (CardioFocus Inc.) versus standard RF ablation. Methods Patients referred for ablation of paroxysmal and persistent AF were enrolled to the study. The EnSite Precision 3D mapping system (Abbott) was used for left atrial mapping, a Tacticath CF ablation catheter (Abbott) was employed for point-to-point catheter ablation. Patients were randomly assigned to be treated by either PFA (CENTAURI PEF generator) or RF (RF generator Ampere, Abbott) ablation. Periprocedural parameters and two years follow-up outcomes were compared between the two groups. Results From 2nd January 2023 to 7th July 2025 a total of 236 patients underwent catheter ablation for AF. 117 patients had paroxysmal AF, 118 persistent AF. 122 patients were treated with PFA (PFA group), and 113 patients with RF energy (RFA group). The baseline characteristics of both groups were similar: 28% and 32% resp. were women, the average age was 61 and 63 years resp. and the mean left atrial size was 42 and 45 mm resp. The average total procedure time was 118 minutes for the PFA group and 158 minutes for the RFA group. The X-ray dose was 2379 mGy·cm² and 3651 mGy·cm² resp. The isolation time for the left pulmonary veins (LPVs) was 18 minutes for PFA and 29 minutes for RFA. PFA application time for LPVs was 180 seconds, compared to 1204 seconds for RF energy application. The isolation time of the right pulmonary veins (RPVs) was 19 minutes for PFA and 29,5 minutes for RFA. PFA application time at the RPVs was 187 seconds, compared to 1401 seconds of RF energy application. First-pass isolation was in 98% for the LPVs and in 94% for the RPVs in the PFA group, compared to 84% and 80% in the RFA group. No severe acute or subacute complications were recorded in either group. A total of 104 patients with paroxysmal AF returned for outpatient visits at 24 months. In the PFA group, sinus rhythm was maintained in 70% of patients, in the RFA group in 74% of patients. A total of 93 patients with persistent AF returned for outpatient visits at 24 months. In the PFA group, sinus rhythm was maintained in 76% of patients, while in the RFA group persisted in 66% of patients. When analyzing both paroxysmal and persistent AF cases, the results were similar between the two groups. Conclusions Point-to-point catheter ablation supported by standard 3D mapping with PFA results in shorter procedure times, faster ipsilateral pulmonary vein isolation, shorter energy application times and higher probability of first-pass isolation, while maintaining similar procedureal safety. Long-term efficacy is similar, but folow up is not yet finished.
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Starek et al. (2026) conducted an RCT in Paroxysmal and persistent atrial fibrillation (n=236). Pulsed-field ablation (CENTAURI PEF system) vs. Standard radiofrequency ablation (Ampere RF generator) was evaluated on Maintenance of sinus rhythm at 24 months and periprocedural parameters. Pulsed-field ablation yielded shorter procedure times (118 vs 158 min) and similar 24-month sinus rhythm maintenance in paroxysmal (70% vs 74%) and persistent AF (76% vs 66%) compared to RF ablation.
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