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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Procedure: Atrial fibrillation ablation

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.

• Study Type: Observational
• Enrollment (Actual): 5223

Contacts and Locations

Study Locations

• France
  • Rouen, France, 76000
    • University Hospital of Rouen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

All patients who underwent for the first time an atrial fibrillation ablation procedure, with pulmonary veins isolation performed with the pentaspline PFA catheter in France will be included in the registry

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Paroxysmal atrial fibrillation patients; patients with paroxysmal atrial fibrillation undergoing first time catheter ablation using the pentaspline PFA catheter	Procedure: Atrial fibrillation ablation; Pulmonary veins isolation potentially associated with other atrial lesions, performed with the pentaspline PFA catheter; Other Names: Pulsed field ablation procedure using the Faradrive catheter (Boston Scientific)
Persistent atrial fibrillation patients; patients with persistent atrial fibrillation undergoing first time catheter ablation using the pentaspline PFA catheter	Procedure: Atrial fibrillation ablation; Pulmonary veins isolation potentially associated with other atrial lesions, performed with the pentaspline PFA catheter; Other Names: Pulsed field ablation procedure using the Faradrive catheter (Boston Scientific)
Long-standing persistent atrial fibrillation patients; patients with long-standing persistent atrial fibrillation undergoing first time catheter ablation using the pentaspline PFA catheter	Procedure: Atrial fibrillation ablation; Pulmonary veins isolation potentially associated with other atrial lesions, performed with the pentaspline PFA catheter; Other Names: Pulsed field ablation procedure using the Faradrive catheter (Boston Scientific)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
long-term efficacy (AA)	freedom from all types of atrial arrhythmia recurrences	within 1-year period post-procedure
very long-term efficacy (AA)	freedom from all types of atrial arrhythmia recurrences	Within 2 years period post-procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
long term efficacy (AF)	freedom from atrial fibrillation recurrences	within 1-year period post-procedure
very long-term efficacy (AF)	freedom from atrial fibrillation recurrences	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	within 1-month post-procedure

Collaborators and Investigators

• Sponsor: University Hospital, Rouen
• Investigators: Principal Investigator: Frederic ANSELME, MD, PhD, Rouen University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2021
• Primary Completion (Actual): March 1, 2023
• Study Completion (Estimated): March 1, 2026

Study Registration Dates

• First Submitted: July 4, 2024
• First Submitted That Met QC Criteria: July 4, 2024
• First Posted (Actual): July 12, 2024

Study Record Updates

• Last Update Posted (Actual): July 19, 2024
• Last Update Submitted That Met QC Criteria: July 17, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: registry; Pulsed field ablation
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: 2022/0259/OB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes