Farapulse clinical evidence

FARAPULSE PULSED FIELD ABLATION SYSTEM

Unrivalled design combined with robust
clinical evidence

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

Watch Dr Vivek Y. Reddy discuss the randomized ADVENT Pivotal Trial results – PFA Vs Thermal Ablation

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.

Explore more about ADVENT

The MANIFEST-PF results are in.

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​

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.

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)

Read the Clinical Compendium

Read the Clinical Compendium

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

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Learn from the experts about clinical evidence supporting PFA:

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. 

Prof. KR Julian Chun presents the updated experience from the CCB group with the FARAPULSE PFA System.

Prof. Serge Boveda dissects the MANIFEST study on FARAPULSE PFA.

Discover the clinical data to support the FARAPULSE PFA workflow:

No PFA system is more validated.

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: 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

Incidence of PV reconnection

Study report on electrophysiological findings in patients with recurrent ATA to evaluate durability and reconnection rate.

Tohoku et al. "Findings from repeat ablation using high-density mapping after pulmonary vein isolation with pulsed field ablation." EP Europace 00,  1-8. (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

Lesion assessment with UHDx mapping

PFA lesion creation investigation with ultra high-density mapping to assess the occurrence of early PV reconnection rate.

Gunawardene et al. "Pulsed-field ablation combined with ultrahigh-density mapping in patients undergoing catheter ablation for atrial fibrillation: Practical and electrophysiological considerations." J Cardiovasc Electrophysiol. (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 Characterisation

PFA created antral lesions as encompassing as thermal ablation modalities

Kawamura, Iwanari, et al. “How does the level of pulmonary venous isolation compare between pulsed field ablation and thermal energy ablation (radiofrequency, cryo, or laser)?” EP Europace (2021).
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 less fibrotic healing

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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