Pulsed field ablation (PFA) is a nonthermal ablative modality using a strong electrical field created around a dedicated catheter to produce pores in the cellular membrane. As the amount of energy required to produce electroporation is highly tissue dependent, the atrial myocardium can be specifically targeted while sparing adjacent tissues. This new ablation modality could increase the safety of pulmonary vein isolation (PVI) procedures compared to PVI using thermal energies. The investigators aim to provide the first exhaustive Nationwide registry using the pentaspline PFA catheter to treat atrial fibrillation patients.
This is a multicenter observational research project, that prospectively included patients undergoing a first time atrial fibrillation ablation using the Farapulse technology (Boston Scientific) since the start of this technology in France. All patients treated with the Farapulse technology for atrial fibrillation in France from March 2021 to February 29th of 2024 will be included in the registry. The number of participating centers is 33. A one-year and 2-year follow-up will be performed according to the standard practices of the different centers. The study duration will be 5 years.
Study Type
OBSERVATIONAL
Enrollment
5,223
Pulmonary veins isolation potentially associated with other atrial lesions, performed with the pentaspline PFA catheter
University Hospital of Rouen
Rouen, France
long-term efficacy (AA)
freedom from all types of atrial arrhythmia recurrences
Time frame: within 1-year period post-procedure
very long-term efficacy (AA)
freedom from all types of atrial arrhythmia recurrences
Time frame: Within 2 years period post-procedure
long term efficacy (AF)
freedom from atrial fibrillation recurrences
Time frame: within 1-year period post-procedure
very long-term efficacy (AF)
freedom from atrial fibrillation recurrences
Time frame: Within 2 years period post-procedure
Safety outcomes
the composite of major adverse events, including esophageal complications, symptomatic PV stenosis, cardiac tamponade requiring intervention, stroke or systemic thromboembolism, persistent phrenic nerve injury, vascular access complications requiring surgery, coronary artery spasm, and death
Time frame: within 1-month post-procedure
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