NCT06497933

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

Exhaustive French National Online Registry of Atrial Fibrillation Ablation Procedures Using the Pentaspline Pulsed Field Ablation Catheter

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 5,223 (actual)
• Sponsor: University Hospital, Rouen · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Atrial Fibrillation

Interventions

Type	Name	Description
PROCEDURE	Atrial fibrillation ablation	Pulmonary veins isolation potentially associated with other atrial lesions, performed with the pentaspline PFA catheter

Timeline

• Start date: 2021-03-01
• Primary completion: 2023-03-01
• Completion: 2026-03-01
• First posted: 2024-07-12
• Last updated: 2024-07-19

Locations

1 site across 1 country: France