Exhaustive French National Registry of AF Ablation Using Pentaspline Pulsed Field Ablation Catheter (FRANCE-PFA)

University Hospital, Rouen

Status: Active, not recruiting

Conditions: Atrial Fibrillation

Treatments: Procedure: Atrial fibrillation ablation

Study type: Observational

Funder types: Other

Identifiers

NCT06497933

2022/0259/OB

Details and patient eligibility

About

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.

Full 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.

Enrollment: 5,223 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients aged ≥18 years
• Patients who received catheter ablation for paroxysmal AF, persistent AF, or long-standing persistent AF.

Exclusion criteria

• Previous left atrial ablation.
• Patient's opposition to participating in this registry

Trial design

5,223 participants in 3 patient groups

Paroxysmal atrial fibrillation patients

Description:

patients with paroxysmal atrial fibrillation undergoing first time catheter ablation using the pentaspline PFA catheter

Treatment:

Procedure: Atrial fibrillation ablation

Persistent atrial fibrillation patients

Description:

patients with persistent atrial fibrillation undergoing first time catheter ablation using the pentaspline PFA catheter

Treatment:

Procedure: Atrial fibrillation ablation

Long-standing persistent atrial fibrillation patients

Description:

patients with long-standing persistent atrial fibrillation undergoing first time catheter ablation using the pentaspline PFA catheter

Treatment:

Procedure: Atrial fibrillation ablation