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FARAPULSE™

Pulsed Field Ablation System

Transformative clinical leadership in PFA

Advantage AF Clinical datapoints

ADVANTAGE AF US IDE Clinical Trial Results (Phase I)1

The ADVANTAGE AF trial measured the safety and effectiveness of the FARAPULSE™ Pulsed Field Ablation (PFA) System for patients with drug refractory, symptomatic persistent atrial fibrillation (PersAF). Ablation treatment included both pulmonary vein isolation and posterior wall ablation.
Download clinical summary
CAUTION: Investigational Device. Limited by Federal (or US) law to investigational use only. Ablation of patients with persistent atrial fibrillation or ablation beyond pulmonary vein isolation are outside the labeled indication(s) for use of the FARAWAVE™ PFA Catheter with the FARAPULSE PFA System. FARAWAVE™ NAV PFA Catheter was not used in this study.

KEY FINDINGS

  • At 12 months, the primary safety event rate was 2.3% [5.1% UCL] which met the 12.0% performance goal.
  • At 12 months, the primary effectiveness rate was 63.5% [57.3% LCL] which met the acceptance criteria of 40.0%.
  • 4.6% LA re-ablation rate with 84.4% PV durability at redo and 68.8% PW durability at redo.
  • At 12 months, 85.3% of patients were free from documented symptomatic AA recurrence.
PRIMARY SAFETY ENDPOINT: A composite endpoint defined as serious adverse events related to either the use of an ablation catheter or the ablation procedure with onset within 7 days of the primary procedure and pulmonary vein stenosis or atrio-esophageal fistula out to 12 months.

PRIMARY EFFECTIVENESS ENDPOINT: A composite endpoint defined as acute and chronic ablation success through 12 months. After the 90-day blanking period, chronic success was defined as freedom from AF, AFL or AT, re-ablation, cardioversion and use of a new or escalated dose of Class I/III AADs or Amiodarone.
 
Clinical compendium

Clinical Compendium

Explore the latest update to the FARAPULSE™ clinical compendium. With over 150 publications, case studies, and pre-clinical studies summarized for easy access, staying informed is simpler than ever. Explore a topic-based list to quickly find information on safety, clinical outcomes, real-world data, lesion characterization, and biomarkers.
Download the PDF
Clinical Data Brochure

Clinical Data Brochure

Extensively researched and used in 200,000+ patients around the world, FARAPULSE™ Pulsed Field Ablation holds more published clinical evidence than any other pulsed field ablation (PFA) system. Global real-world experience includes multiple large-scale registries and robust clinical data from independent studies, with more trials underway.
Download the PDF
 

Dedicated to transforming PFA

Since receiving CE mark in 2021 and FDA approval in 2024, more than 200,000 patients have been treated with FARAPULSE PFA. Along the way, we’ve continued to define, optimize, and validate pulsed field ablation therapy.
55 clinical trials
150 publications
More than 3 years of commercial use
 

Explore robust clinical data

Recurrent Atrial Arrhythmia Burden2, 3
ADVENT Pivotal Trial

FARAPULSE AF ablation procedure time and catheter left atrium (LA) dwell time were significantly shorter than thermal ablation

The ADVENT Pivotal Trial sub-analysis compared FARAPULSE to standard-of-care thermal ablation (RFA and CBA) for recurrent Atrial Arrhythmia (AA). Patients treated with FARAPULSE showed a significantly greater reduction in AA Burden than thermal ablation.

Key Findings:

  • Significantly greater quality-of-life (QoL) improvements in patients with AA Burden <0.1% vs. ≥10%
  • Significantly lower risk for redo ablation, cardioversion, and hospitalization with AA Burden <0.1% vs. ≥0.1%
  • FARAPULSE patients were significantly more likely to have AA Burden <0.1% than RFA and CBA
Download ADVENT AA Burden Clinical Data Summary

ADVENT Pivotal Trial3

FARAPULSE AF ablation procedure time and catheter left atrium (LA) dwell time were significantly shorter than thermal ablation

The first and only randomized clinical trial that directly compares PFA to standard-of-care thermal ablation devices (force-sensing radiofrequency (RFA) or cryoballoon ablation (CBA), for the treatment of paroxysmal atrial fibrillation (PAF)).

Key Findings:

  • The FARAPULSE AF ablation procedure time and catheter left atrium (LA) dwell time were significantly shorter than thermal ablation
  • Met the primary safety and efficacy non-inferiority endpoints
  • PFA showed no instances of serious thermal complications
Download ADVENT Clinical Data Summary
 

MANIFEST-17K Multicenter Registry4

Major adverse event rates were less than one percent.

A retrospective observational study of the real-world commercial use of FARAPULSE PFA including data from 106 centers (91.4% of all commercial centers using FARAPULSE), 413 operators, and 17,642 patients.

Key Findings:

  • Major adverse event rates were low (<1%)
  • No reports of esophageal fistula, pulmonary vein stenosis or persistent phrenic nerve injury in the largest PFA registry to date
Download MANIFEST 17-K Clinical Data Summary

EU-PORIA5

Shorter procedure times

A multi-center registry studying the real-world adoption, workflow, acute and long-term outcomes after PFA in an all-comer atrial fibrillation (AF) patient population in high-volume European centers.

Key Findings:

  • Demonstrated rapid adoption of the technology by new operators and prior RF and cryo users
  • Operator experience and previous primary ablation modality did not have an effect on one-year recurrence rates
Download EU-PORIA Clinical Data Summary
 
 

Additional clinical data

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.
Download PERFECT-PAF Clinical Data Summary
 
Lead physician: Bisignani A

National Workflow Experience with Pulsed Field Ablation for Atrial Fibrillation: Learning Curve, Efficiency, and Safety7

Discover the difference with FARAPULSE! 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 DG

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%).
 
 
 
FARAPULSE Pulsed Field Ablation System Indications, Safety and Warnings
 

References:

1. Reddy, et al., Safety and Efficacy of Pulsed Field Ablation for Persistent Atrial Fibrillation: One-Year Results of ADVANTAGE AF. AF Symposium 2025, Boston, MA.
2. 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. null2024, 0 (0). https://doi.org/10.1016/j.jacc.2024.05.001
3. 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
4. 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
5. Schmidt B, Bordignon S, Neven K, et al., EUropean real-world outcomes with Pulsed field ablatiOn in patients with symptomatic atrial fibrillation: lessons from the multi-centre EU-PORIA registry. Europace. 2023;25(7):euad185. doi:10.1093/europace/euad185
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. 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

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