Atrial Fibrillation
Conditions
Keywords
Pulsed field ablation, registry
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.
Interventions
PROCEDUREAtrial fibrillation ablation
Pulmonary veins isolation potentially associated with other atrial lesions, performed with the pentaspline PFA catheter
Sponsors
University Hospital, Rouen
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
France
Outcome results
None listed