Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Observational Study
. 2025 Aug;36(8):1957-1965.
doi: 10.1111/jce.16761. Epub 2025 Jun 12.

Direct Comparison of Two Commercially Available Pulsed Field Ablation Systems for Atrial Fibrillation; Procedure Characteristics and Acute Outcomes

Bob G S Abeln  1   2 , Marisa van der Graaf  1   2 , Dan L Musat  3 , Melanie A Gunawardene  4 , Devi G Nair  5 , Bradley P Knight  6 , Bradley Wilsmore  7 , Max Liebregts  1 , Vincent F van Dijk  1 , Maurits C E F Wijffels  1 , Jippe C Balt  1 , Suneet Mittal  3 , Stephan Willems  4 , Nishant Verma  6 , Graham Peigh  6 , Michael M Malaty  7 , Lucas V A Boersma  1   2
Affiliations
Observational Study

Direct Comparison of Two Commercially Available Pulsed Field Ablation Systems for Atrial Fibrillation; Procedure Characteristics and Acute Outcomes

Bob G S Abeln et al. J Cardiovasc Electrophysiol. 2025 Aug.

Abstract

Background: There are few comparative studies on the everyday clinical outcomes of commercially available pulsed field ablation (PFA) systems for atrial fibrillation (AF).

Objective: This study evaluates the acute efficacy and safety outcomes of the FARAPULSE™ (pentaspline catheter) and PulseSelect™ (circular catheter) system.

Methods: International, multicenter, registry on patients with paroxysmal or persistent AF, undergoing a first ablation using either PFA system between January 29th, 2024 and September 1st, 2024. Primary endpoints were electrical isolation of ablation targets, procedural characteristics and freedom from major adverse events within 30 days postprocedure.

Results: A total of 402 patients were enrolled at the six participating centers, of whom 56.5% were treated with the pentaspline ablation-catheter. Acute procedural efficacy was 100% for both groups. Use of the pentaspline ablation-catheter was associated with significantly shorter procedural times (36.0 min [IQR 31.0; 44.0] vs. 49.0 min [IQR 41.5;76.0]) compared to the circular ablation-catheter (p < 0.001). Major adverse events were scarce and not different between cohorts. Two patients (0.5%) experienced a stroke and one patient (0.2%) had a serious vascular access site complication. One patient had a transient ischemic attack (0.2%). Minor vascular access site complications were more common in the pentaspline catheter group (11.9% vs. 1.1%, p < 0.001).

Conclusions: This study showed excellent acute efficacy and safety for both PFA-systems. Our findings reveal shorter procedural times with the pentaspline catheter, less minor access site complications with the circular catheter, and several procedural differences between the ablation systems, often driven by operator choice.

Keywords: atrial fibrillation; catheter ablation; efficacy; pulmonary vein isolation; pulsed field ablation; safety.

PubMed Disclaimer

Conflict of interest statement

The full disclosures of any potential conflict of interest are as follows: D.M. reports being a consultant for AltaThera Pharmaceuticals. B.K. has served as a consultant for and participated in PFA clinical trials sponsored by Abbott, Boston Scientific, and Medtronic. B.W. reports being a speaker/advisor for Medtronic and Boston Scientific. M.G. reports receiving speaker's honoraria, travel grants, and consulting honoraria from Abbott, Biosense Webster, Boston Scientific/Farapulse Inc, Medtronic, Lumavision, Biotronik, Bristol‐Myers Squibb, and Zoll. S.M. has served as a consultant for and participated in PFA clinical trials sponsored by Boston Scientific and Medtronic. V.H. received speaker's honoraria and consulting honoraria from Abbott, Biosense Webster, Boston Scientific, Medtronic, Zoll, and AltaThera Pharmaceuticals. L.B. reports being consultant/speaker/proctor for Boston Scientific and Medtronic and speaker for ZOLL, Biosense Webster and Abbott. All fees go to the cardiology department. The remaining authors declare no conflicts of int.

References

    1. Erinjeri J. P. and Clark T. W. I., “Cryoablation: Mechanism of Action and Devices,” Journal of Vascular and Interventional Radiology 21, no. S8 (2010): S187–S191, 10.1016/j.jvir.2009.12.403. - DOI - PMC - PubMed
    1. Liu D., Li Y., and Zhao Q., “Effects of Inflammatory Cell Death Caused by Catheter Ablation on Atrial Fibrillation,” Journal of Inflammation Research 16 (2023): 3491–3508, 10.2147/JIR.S422002. - DOI - PMC - PubMed
    1. Ekanem E., Reddy V. Y., Schmidt B., et al., “Multi‐National Survey on the Methods, Efficacy, and Safety on the Post‐Approval Clinical use of Pulsed Field Ablation (MANIFEST‐PF),” EP Europace 24, no. 8 (2022): 1256–1266, 10.1093/europace/euac050. - DOI - PMC - PubMed
    1. Kotnik T., Rems L., Tarek M., and Miklavčič D., “Membrane Electroporation and Electropermeabilization: Mechanisms and Models,” Annual Review of Biophysics 48 (2019): 63–91, 10.1146/annurev-biophys-052118-115451. - DOI - PubMed
    1. Cappato R., Calkins H., Chen S.‐A., et al., “Updated Worldwide Survey on the Methods, Efficacy, and Safety of Catheter Ablation for Human Atrial Fibrillation,” Circulation: Arrhythmia and Electrophysiology 3, no. 1 (2010): 32–38, 10.1161/CIRCEP.109.859116. - DOI - PubMed