Exhaustive French National Online Registry of Atrial Fibrillation Ablation Procedures Using the Pentaspline Pulsed Field Ablation Catheter
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Atrial Fibrillation
- Sponsor
- University Hospital, Rouen
- Enrollment
- 5223
- Locations
- 1
- Primary Endpoint
- long-term efficacy (AA)
- Status
- Active, not recruiting
- Last Updated
- last year
Overview
Brief 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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
long-term efficacy (AA)
Time Frame: within 1-year period post-procedure
freedom from all types of atrial arrhythmia recurrences
very long-term efficacy (AA)
Time Frame: Within 2 years period post-procedure
freedom from all types of atrial arrhythmia recurrences
Secondary Outcomes
- long term efficacy (AF)(within 1-year period post-procedure)
- very long-term efficacy (AF)(Within 2 years period post-procedure)
- Safety outcomes(within 1-month post-procedure)