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.​

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)

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)

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)

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)

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)

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.

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).

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.

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).

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.

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).

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).

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.

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.

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.