Farapulse clinical evidence

FARAPULSE PULSED FIELD ABLATION SYSTEM

Unrivalled design combined with robust
clinical evidence

Clinical leadership in PFA

Extensively researched and used in over 200,000 patients globally, FARAPULSE Pulsed Field Ablation holds more published clinical evidence than any other Pulsed Field Ablation (PFA) system.

Transformative clinical leadership in PFA 

ADVANTAGE AF Clinical Trial1

The ADVANTAGE AF phase I 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 (PVI) and posterior wall ablation (PWA).

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.

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.

Watch Dr Vivek Y. Reddy and Brad Sutton, Global Chief Medical Offer review ADVANTAGE trial results

ADVENT Pivotal Trial


Watch Dr Vivek Y. Reddy discuss the randomized ADVENT Pivotal Trial results showing shorter ablation procedure and catheter left atrium (LA) dwell times - PFA Vs Thermal Ablation

Discover more about the ADVENT Pivotal Trial. It is the first randomised clinical trial that directly compares FARAPULSE PFA to standard-of-care thermal ablation devices (force-sensing radiofrequency (RFA) or cryoballoon ablation (CBA)), for the treatment of paroxysmal atrial fibrillation (PAF).​

Access our dedicated ADVENT Trial web pages

MANIFEST-17K Multicentre Registry

Access the MANIFEST-17K infographic

Access the latest outcomes from the MANIFEST-17K retrospective observational study of the real-world commercial use of FARAPULSE PFA showing <1% major adverse event rate with no reports of esophageal fistula, pulmonary vein stenosis or persistent phrenic nerve injury

Download

Watch Dr Ante Anić discuss the MANIFEST-17K results - the largest real-world safety registry of any PFA system

Explore more about MANIFEST-17K registry

MANIFEST-PF 1 year outcomes

Review the findings and the outcome results at 1 year from the multi-national study on the methods, efficacy and safety of Pulsed Field Ablation (PFA) in a real-world setting.

Read the publication​

AVANT-GUARD clinical trial
Learn more about the trial and how to participate

Access the webpage for healthcare professionals
Read the Clinical Compendium

Read the Clinical Compendium

Find publication overviews and key takeaways from all the latest PFA studies.

Download

Discover more about the PERFECT-PAF Randomized Clinical Trial. 

The study objective was to assess the clinical safety and economic value of FARAPULSE PFA versus cryoablation (CBA) in a randomised, controlled and non-inferiority trial. 

Download the Data Summary

Learn from the experts about clinical evidence supporting PFA:

Listen to Prof. Dello Russo to discover the most important results and main learnings coming from the ATHENA registry on FARAPULSE PFA.​

Listen to Prof. Schmidt to gain valuable insights on the multicenter EUPORIA registry. ​

 

Dr. Gunawardene shares her experience with FARAPULSE PFA, recognizing fast and predictable PVI, with high durability rates and a good safety profile.

Watch Prof. Chun explain how FARAPULSE PFA for PVI is simple, safe and effective, while showing reproducible procedures which are operator independent. 

Discover the clinical data to support the FARAPULSE PFA workflow:

Additional clinical data

The FARAPULSE PFA System is pioneering PFA with the first commercially available system for cardiac arrhythmias. Purpose-engineered, optimised and validated over 10 years through multiple pre-clinical and clinical trials and an ever-growing number of patients treated, the FARAPULSE PFA System holds more published clinical evidence than any other pulsed field ablation system.

Real-world data: EU-PORIA registry

​The EU-PORIA registry includes all-comer AF patients from seven high-volume centres consecutively enrolled. Procedural and follow-up data were collected. Learning curve effects were analysed by operator ablation experience and primary ablation modality.

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 Multicenter EU-PORIA Registry. EURPOACE (July, 2023)

Review Study Findings

Real-world data: durable PVI

1 year outcomes from the MANIFEST-PF registry including device learning curve with the FARAPULSE PFA System.

Turagam et al., Safety and Effectiveness of Pulsed Field Ablation to Treat Atrial Fibrillation: One-Year Outcomes From the MANIFEST-PF Registry, Circulation 2023.​

Review Study Findings

Acute safety, efficacy and short-term follow-up

Multicenter report in a real-word performance of a PFA-based system in patient with AF, evaluating safety, efficacy and short-term follow-up.

Marc D. Lemoine et al. "Pulsed‑field ablation‑based pulmonary vein isolation: acute safety, efficacy and short‑term follow‑up in a multi‑center real world scenario." Clinical Research in Cardiology. (2022)

Review Study Findings

Antral lesion characterization

Real-word experience with PFA for PVI to compare antral lesions between PFA and cryoablation systems.

Christian Blockhaus et al. "Pulsed field ablation for pulmonary vein isolation: real-world experience and characterization of the antral lesion size compared with cryoballoon ablation." Journal of Interventional Cardiac Electrophysiology. (2022)

Review Study Findings


Use of a novel Pulsed Field Ablation catheter in combination with an ultra-high-definition basket mapping catheter in a de-novo PVI procedure (2024)
Learn how Dr Szeplaki (Mater Private, Dublin) leverages ultraHD mapping and Pulsed Field Ablation for an efficient PVI patient treatment.

Review the case report here


 

FARAPULSE PFA in CIEDs

Safety assessment with pulsed field ablation for PVI in patients with cardiac implantable devices.

Chen et al. "Pulsed field ablation‑based pulmonary vein isolation in atrial fibrillation patients with cardiac implantable electronic devices: practical approach and device interrogation (PFA in CIEDs)." Journal of Interventional Cardiac Electrophysiology. (2022)
Review Study Findings

Real-World: 5S Study

Real-world assessment of technology adoption/learning curve

Schmidt, Boris, et al. “5S Study: Safe and Simple Single Shot Pulmonary Vein Isolation With Pulsed Field Ablation Using Sedation.” Circulation: Arrhythmia and Electrophysiology 15.6 (2022): e010817.
Review Study Findings

Real-World: MANIFEST-PF

Real-world acute data from over 1700 patients

Ekanem, Emmanuel, et al. “Multi-national survey on the methods, efficacy, and safety on the post-approval clinical use of pulsed field ablation (MANIFEST-PF).” Europace (2022).
Review Study Findings

Safety and Efficacy

IMPULSE, PEFCAT and PEFCAT II: 85 ± 5% freedom from atrial arrythmias*

*For optimised biphasic energy PFA waveform cohort. Reddy, Vivek Y., et al. “Pulsed field ablation of paroxysmal atrial fibrillation: 1-year outcomes of IMPULSE, PEFCAT, and PEFCAT II.” Clinical Electrophysiology 7.5 (2021): 614-627.
Review Study Findings

Lesion Durability

Antral PFA lesions persisted at 3-month remapping

Kawamura, Iwanari, et al. “Does pulsed field ablation regress over time? A quantitative temporal analysis of pulmonary vein isolation.” Heart Rhythm 18.6 (2021): 878-884.
Review Study Findings

Safety: Oesophagus

No detected acute or chronic oesophageal lesions

Cochet, Hubert, et al. “Pulsed field ablation selectively spares the oesophagus during pulmonary vein isolation for atrial fibrillation.” EP Europace (2021).
Review Study Findings

Left Atrial Structural Mechanics

Preserved left atrial tissue compliance suggested differential lesion characteristics​

Nakatani, Yosuke, et al. “Pulsed field ablation prevents chronic atrial fibrotic changes and restrictive mechanics after catheter ablation for atrial fibrillation.” EP Europace (2021).

Review Study Findings

Safety: PV Stenosis

No measured ostial narrowing or stenosis

Kuroki, Kenji, et al. “Ostial dimensional changes after pulmonary vein isolation: Pulsed field ablation vs radiofrequency ablation.” Heart Rhythm 17.9 (2020): 1528-1535.
Review Study Findings

First-In-Human Trials

IMPULSE and PEFCAT safety and efficacy

Reddy V, Neuzil P, Koruth J, et al. “Pulsed Field Ablation for Pulmonary Vein Isolation in Atrial Fibrillation.” Journal of the American College of Cardiology. 2019 Jul, 74 (3) 315–326.
Review Study Findings

First-In-Human Feasibility

Ultra-rapid, tissue-selective ablation: both epicardial and endocardial

Reddy VY, Koruth J, Jais P, et al. JACC: Clin Electrophysiol. 2018 Aug:4(8);987–95.
Review Study Findings

Pulsed Field Ablation Versus Radiofrequency Ablation

Koruth J, Kuroki K, Kawamura I, Brose R, Viswanathan R, Buck E, Donskoy E, Neuzil P, Dukkipati S, Reddy V Arrhythmia and Electrophysiology (2020, e-published).
Review Study Findings

Endocardial ventricular pulsed field ablation: a proof-of-concept preclinical evaluation

Koruth J, Kuroki K, Iwasawa J, Viswanathan R, Brose R, Buck E, Donskoy E, Dukkipati S, Reddy V
EP Europace, euz341
Review Study Findings

Preclinical Evaluation of Pulsed Field Ablation

Koruth J, Kuroki K, Iwasawa J, Enomoto Y, Viswanathan R, Brose R, Buck E, Speltz M, Dukkipati S, Reddy V
Circulation: Arrhythmia and Electrophysiology (2019).
Review Study Findings

Pulsed Field Ablation for Pulmonary Vein Isolation in Atrial Fibrillation

Reddy V, Neuzil P, Koruth J, Petru J, Funosako M, Cochet H, Sediva L, Chovanec M, Dukkipati S, Jais P
Journal of the American College of Cardiology (2019).
Review Study Findings

Finally we have technology that can help us increase procedural success rates, especially in complex forms of atrial fibrillation.

Prof. Gabor Szeplaki
Prof. Claudio Tondo​
Centro Cardiologico Monzino, Milan​

Pulsed field ablation is a very powerful technology for pulmonary vein isolation... A stringent ablation workflow is essential for durable good results.

Prof Dr Michael Gramlich
Prof. Dr. Michael Gramlich
University Aachen, Aachen

Case studies, reports, and presentations.

Stay current with the latest findings and best practices for pulsed field ablation, available anytime through our convenient EDUCARE learning platform.

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REFERNCES:

1. Reddy, et al. Safety and Efficacy of Pulsed Field Ablation for Persistent Atrial Fibrillation: One-Year Results of ADVANTAGE AF. Presented by Dr. Vivek Reddy at the Atrial Fibrillation Symposium 2025, Boston, MA​
 

CAUTION:
The law restricts these devices to sale by or on the order of a physician. Indications, contraindications, warnings, and instructions for use can be found in the product labelling supplied with each device or at www.IFU-BSCI.com. Products shown for INFORMATION purposes only and may not be approved or for sale in certain countries. This material not intended for use in France.