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PFA clinical data

NEW ADVANTAGE AF Phase II clinical data results

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Transformative clinical leadership in PFA

FARAPULSE™ Pulsed Field Ablation (PFA) System has the largest PFA safety registry1 and has treated more than 200,000+ patients worldwide and counting.

Clinical compendium

Clinical compendium

Discover over 150 summarized publications, case studies, and pre-clinical studies for insights into safety, real-world data, clinical outcomes, biomarkers and more.

Clinical Data Brochure

Clinical data brochure

With large-scale registries, clinical data from independent studies, and more trials underway, FARAPULSE holds more published clinical evidence than any other PFA system.

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Reddy et. al, 2025

ADVANTAGE AF US IDE trial (Phase I and Phase II)2

The ADVANTAGE AF US IDE Phase I clinical trial measured the safety and effectiveness of the FARAPULSE PFA System 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 trial3

The SINGLE SHOT CHAMPION trial is the first randomized clinical trial that directly compared the safety and effectiveness of the FARAPULSE™ PFA  System 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

Ekanem et al. 2024

MANIFEST-17K Multicenter Registry1

MANIFEST-17K Multicenter Registry is a retrospective observational study of the real-world commercial use of the FARAPULSE PFA System. 

Explore MANIFEST-17K trial results

Reddy et. al, 2024 and 2023

ADVENT trial4 and atrial arrhythmia (AA) burden sub-analysis4,5

The ADVENT trial is the first randomized clinical trial that directly compared PFA 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 the FARAPULSE PFA System to standard-of-care thermal ablation for recurrent AA.  

Explore ADVENT trial results

Independent research

Lead physician: Chierchia G.

Pulsed Electric Field versus Cryoballoon to Treat Paroxysmal Atrial Fibrillation (PERFECT-PAF) Randomized Trial: A Periprocedural Clinical and Cost Analysis6

FARAPULSE (n=134) outperformed conventional cryoballoon ablation (CBA, n=135) in a 6-center randomized 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 Safety7

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 Roca D.G.

Pulsed Electric Field, Cryoballoon, and Radiofrequency for Paroxysmal Atrial Fibrillation Ablation: A Propensity Score-Matched Comparison8

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 Study9

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%).

References

1. 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

2. Reddy, Vivek, et al. (in press). “Pulsed Field of Persistent Atrial Fibrillation with Continuous ECG Monitoring Follow-Up.” Circulation.

3. Reichlin, et al. Pulsed field ablation or cryoballoon ablation for paroxysmal atrial fibrillation - the SINGLE SHOT CHAMPION randomized clinical trial. EHRA, 2025.

4. 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. https://www.nejm.org/doi/full/10.1056/NEJMoa2307291

5. 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. doi:10.1016/j.jacc.2024.05.001

6. 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.

7. 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.

8. 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

9. 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