Exhaustive French National Registry of AF Ablation Using Pentaspline Pulsed Field Ablation Catheter
- Conditions
- Atrial Fibrillation
- Interventions
- Procedure: Atrial fibrillation ablation
- Registration Number
- NCT06497933
- Lead Sponsor
- University Hospital, Rouen
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 5223
- Patients aged ≥18 years
- Patients who received catheter ablation for paroxysmal AF, persistent AF, or long-standing persistent AF.
- Previous left atrial ablation.
- Patient's opposition to participating in this registry
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Paroxysmal atrial fibrillation patients Atrial fibrillation ablation patients with paroxysmal atrial fibrillation undergoing first time catheter ablation using the pentaspline PFA catheter Long-standing persistent atrial fibrillation patients Atrial fibrillation ablation patients with long-standing persistent atrial fibrillation undergoing first time catheter ablation using the pentaspline PFA catheter Persistent atrial fibrillation patients Atrial fibrillation ablation patients with persistent atrial fibrillation undergoing first time catheter ablation using the pentaspline PFA catheter
- Primary Outcome Measures
Name Time Method long-term efficacy (AA) within 1-year period post-procedure freedom from all types of atrial arrhythmia recurrences
very long-term efficacy (AA) Within 2 years period post-procedure freedom from all types of atrial arrhythmia recurrences
- Secondary Outcome Measures
Name Time Method long term efficacy (AF) within 1-year period post-procedure freedom from atrial fibrillation recurrences
very long-term efficacy (AF) Within 2 years period post-procedure freedom from atrial fibrillation recurrences
Safety outcomes within 1-month post-procedure 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
Trial Locations
- Locations (1)
University Hospital of Rouen
🇫🇷Rouen, France