FARAPULSE™ Pulsed Field Ablation (PFA) System PFA clinical data.

PFA clinical data

NEW CLINICAL DATA:

AVANT GUARD Primary Endpoints Met

Explore trial results

The most proven PFA platform

FARAPULSE has built the largest and most comprehensive clinical evidence base in pulsed field ablation, with unmatched volume in peer-reviewed studies, registry participation, and patient outcomes across pivotal trials and real-world registries.*1

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Download the clinical data brochure

Explore FARAPULSE PFA clinical highlights  

AVANT GUARD IDE clinical trial21

Products studied: FARAWAVE​ PFA Catheter

AVANT GUARD IDE is a randomised controlled IDE trial comparing FARAPULSE PFA (FARAWAVE Catheter) to antiarrhythmic drug (AAD) therapy to assess the safety and effectiveness of first-line treatment for patients with persistent atrial fibrillation (persAF). The trial met its primary endpoints and demonstrated superiority over AAD therapy, adding to the extensive and rigorous clinical evidence supporting FARAPULSE PFA.

 

Products shown for informational purposes only – not meant as a promotion or offer for sale. The FARAWAVE Pulsed Field Ablation catheter is not CE Marked as a first line treatment for Persistent Atrial Fibrillation.

Download AVANT GUARD data summary (PDF)

Can be accessed through NEJM: Wazni, et al. Pulsed Field Ablation as Initial Therapy for Persistent Atrial Fibrillation

Reddy et al., 2023, 2024, and 2026

ADVENT trial9, ADVENT AA burden sub-analysis10, and ADVENT long-term outcomes study4

The ADVENT trial is the first randomised clinical trial that directly compared FARAPULSE PFA (with the FARAWAVE™ Pulsed Field Ablation (PFA) Catheter) to standard-of-care thermal ablation—radiofrequency ablation (RFA) and cryoballoon ablation (CBA)—for the treatment of paroxysmal atrial fibrillation (PAF).

The ADVENT trial: AA burden sub-analysis compared FARAPULSE PFA (with the FARAWAVE PFA Catheter) to standard-of-care thermal for recurrent atrial arrythmia (AA).

The ADVENT long-term outcomes (LTO) study—an observational extension of the pivotal ADVENT trial—assessed effectiveness of FARAPULSE PFA (with the FARAWAVE PFA Catheter) vs thermal (RF or cryo) ablation out to 4 years.

Explore ADVENT trial results

Ekanem et al., 2024; Turagam et al., 2025

MANIFEST Multicentre Registries5,13

MANIFEST multicentre Registries are retrospective observational studies of the real-world commercial use of the FARAWAVE PFA Catheter.

Explore MANIFEST trial registries results

BOERSMA, L. ET AL., 2025

Real-World Experience with the Pentaspline Pulsed Field Ablation System: One-Year Outcomes of the FARADISE Registry14

The FARADISE real-world registry (n=1158) underscores the safety and effectiveness of the FARAWAVE PFA Catheter, highlighting consistent results across ablation strategies and operator experience, with efficiency improving as experience grows.

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Reddy et al., 2025

ADVANTAGE AF US IDE trial (Phase I6 and Phase II7)8

The ADVANTAGE AF US IDE Phase I clinical trial measured the safety and effectiveness of the FARAWAVE Pulsed Field Ablation (PFA) Catheter for patients with drug refractory, symptomatic persistent atrial fibrillation.

The ADVANTAGE AF US IDE Phase II clinical trial included the addition of cavo-tricuspid isthmus isolation with the FARAPOINT™ Pulsed Field Ablation Catheter and continuous monitoring with the LUX-Dx™ Insertable Cardiac Monitor System for continuous heart rhythm monitoring.

Explore ADVANTAGE AF trial results

Reichlin, T. et al., 2025

SINGLE SHOT CHAMPION trial12

The SINGLE SHOT CHAMPION trial is the first randomised clinical trial that directly compared the safety and effectiveness of the FARAWAVE PFA Catheter versus Medtronic Arctic Front™ cryoballoon ablation (CBA) to treat symptomatic, drug refractory paroxysmal atrial fibrillation (PAF) with continuous rhythm monitoring.

Explore SINGLE SHOT CHAMPION trial results

Collaborative research

Lead physician: Jaïs P.

BEAT PAROX-AF19, BEAT PERS-AF20

The BEAT PAROX-AF trial was a randomised controlled study designed to compare the efficacy and safety of FARAPULSE PFA with point-by-point RFA in patients with drug-resistant paroxysmal atrial fibrillation (AF).

The BEAT PERS-AF trial was a randomised, non-comparative trial evaluating the efficacy and safety of FARAPULSE PFA to treat drug-resistant persistent AF patients.

Products studied: FARAWAVE™ PFA Catheter

Explore the BEAT PAROX-AF data 

Explore the BEAT PERS-AF trial results

Independent research

Lead physician: Chierchia G.

Pulsed Electric Field versus Cryoballoon to Treat Paroxysmal Atrial Fibrillation (PERFECT-PAF) Randomised Trial: A Periprocedural Clinical and Cost Analysis¹⁵

FARAPULSE (n=134) outperformed conventional cryoballoon ablation (CBA, n=135) in a 6-centre randomised clinical trial. Compared to CBA, FARAPULSE had lower rates of complications, faster and more predictable procedures leading to reduced costs per patient at 30 days.

Lead physician: Bisignani A.

National Workflow Experience with Pulsed Field Ablation for Atrial Fibrillation: Learning Curve, Efficiency, and Safety¹⁶

In a national multicenter registry of over 650 AF ablation procedures, FARAPULSE (n=348) consistently outperformed historical RFA/CBA (n=325) in predictability. Over 90% of FARAPULSE procedures were completed in under 90 minutes, compared to only 60% with RFA/CBA.

Lead physician: Della Rocca D.G.

Pulsed Electric Field, Cryoballoon, and Radiofrequency for Paroxysmal Atrial Fibrillation Ablation: A Propensity Score-Matched Comparison¹⁷

Read more about the first study showing a significantly lower PV reconnection in redo patients for FARAPULSE (19.1%) than thermal, CBA (27.5%) or RFA (34.8%).

Lead physician: Chaumont C.

Pentaspline Pulsed Field Ablation Catheter Versus Cryoballoon for Atrial Fibrillation Ablation: Results From a Prospective Comparative Study¹⁸

See the data: one-year freedom from atrial arrhythmia was significantly higher in the PFA group compared with the cryoballoon group (87.9% versus 77.7%).

*Studied in over 70,700 patients

References

  1.  BSC data on file.
  2.  Listing of publications and clinical trials on file at BSC.
  3. Additional publications by Turagam, Mohit., et al., Ekanem, Emmanuel, et al., Chaumont, Corentin, et al., Wong, Elisabeth, et al., Boersma, Lucas VA, et al., Mills, Mark T., et al., Bisignani, Antonio, et al.
  4. Reddy, V. Y. (2026). Pulsed field versus conventional thermal ablation for paroxysmal atrial fibrillation: 4-year outcomes in the ADVENT-LTO study. Nature Medicine. https://doi.org/10.1038/s41591-026-04246-4
  5. Turagam, Mohit K., et al. "Multicenter Study on the Safety of Pulsed Field Ablation in Over 40,000 Patients: MANIFEST-US." JACC (2025) 
  6. Reddy,  V., Gerstenfeld, E., Schmidt, B., et al., Pulsed Field Ablation for Persistent Atrial Fibrillation: 1-Year Results of ADVANTAGE AF. JACC. 2025 May, 85 (17)
  7. Reddy, V., et al., "Pulsed Field Ablation of Persistent Atrial Fibrillation With Continuous ECG Monitoring Follow-Up: ADVANTAGE AF-Phase 2."Circulation 151.0 (2025).
  8. Gerstenfeld, E. P., et al. (2026). Pulsed field ablation versus standard radiofrequency ablation for typical atrial flutter: ADVANTAGE AF trial substudy. JACC: Clinical Electrophysiology.
  9. Reddy VY, Gerstenfeld EP, Natale A, et al., Pulsed field or conventional thermal ablation for paroxysmal atrial fibrillation. New England Journal of Medicine. 2023; Nov2;389(18):1660-1671. doi:10.1056/NEJMoa2307291 
  10. Reddy V, Mansour M, Calkins H. et al., Pulsed Field vs Conventional Thermal Ablation for Paroxysmal Atrial Fibrillation: Recurrent Atrial Arrhythmia Burden. J Am Coll Cardiol. 2024. 84(1): 61.74. https://doi.org/10.1016/j.jacc.2024.05.001
  11. Reddy, V. et al. (2025). Visualization and chronic assessment of electrical field tags for pulsed field ablation of pulmonary veins with the second-generation pentaspline catheter. Presented at HRS 2025.
  12. Reichlin, Tobias, et al. "Pulsed field or cryoballoon ablation for paroxysmal atrial fibrillation." New England Journal of Medicine 392.15 (2025): 1497-1507."
  13. Ekanem, E., Neuzil, P., Reichlin, T. et al., Safety of pulsed field ablation in more than 17,000 patients with atrial fibrillation in the MANIFEST-17K study. Nat Med (2024). https://doi.org/10.1038/s41591-024-03114-3
  14. Boersma, L., Széplaki, G., Dello Russo, A., et al., Real-world experience with the pentaspline pulsed field ablation system: one-year outcomes of the FARADISE registry, EP Europace, Volume 27, Issue 9, September 2025, euaf182, https://doi.org/10.1093/europace/euaf182
  15. Chierchia G., et al., Pulsed Electric Field versus Cryoballoon to Treat Paroxysmal Atrial Fibrillation (PERFECT-PAF) Randomized Trial: A Periprocedural Clinical and Cost Analysis. ESC, Sept 2, 2024.   
  16. Bisignani, Antonio, et al., "National workflow experience with pulsed field ablation for atrial fibrillation: learning curve, efficiency, and safety." Journal of Interventional Cardiac Electrophysiology (2024): 1-10.
  17. Della Rocca DG, Marcon L, Magnocavallo M, et al., Pulsed electric field, cryoballoon, and radiofrequency for paroxysmal atrial fibrillation ablation: a propensity score-matched comparison, EP Europace, 2024;Jan26(1)euae016. https://doi.org/10.1093/europace/euae016 
  18. Chaumont C, Hayoun C, Savoure A, et al., Pentaspline pulsed field ablation catheter versus cryoballoon for atrial fibrillation ablation: results from a prospective comparative study. Journal of the American Heart Association. 2024;Mar12;0:e03314612 2024doi.org/10.1161/JAHA.123.033146
  19. Jaïs, P. et al., Pulsed field vs radiofrequency ablation for paroxysmal atrial fibrillation: the BEAT PAROX-AF trial, European Heart Journal, 2026.
  20. Jaïs, P. et al., Pulsed field versus radiofrequency ablation for the treatment of persistent atrial fibrillation: The BEAT Pers‑AF trial. EHRA, April 14, 2026.
  21. Wazni OM, Chun JKR, Nair DG, et al. (2026) Pulsed Field Ablation as Initial Therapy for Persistent Atrial Fibrillation. N Engl J Med. Published online April 25, 2026. doi:10.1056/NEJMoa2600929


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