Clinical Trial

Exhaustive French National Registry of AF Ablation Using Pentaspline Pulsed Field Ablation Catheter

Study acronym: FRANCE-PFA
Unknown
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Summary
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.
Protocol Amendment History 1 change
critical Trial status changed: Active, Not Recruiting → Unknown 2026-08-02
Trial Details
NCT Number NCT06497933
Lead Sponsor University Hospital, Rouen
Conditions Atrial Fibrillation
Enrollment 5,223 participants
Start Date 2021-03-01
Primary Completion 2023-03-01 (estimated)
Study Completion 2026-03-01 (estimated)
Updated on ClinicalTrials.gov 2024-07-19