Exhaustive French National Online Registry of Atrial Fibrillation Ablation Procedures Using the Pentaspline Pulsed Field Ablation Catheter
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 5,223
- 试验地点
- 1
- 主要终点
- long-term efficacy (AA)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged ≥18 years
- •Patients who received catheter ablation for paroxysmal AF, persistent AF, or long-standing persistent AF.
排除标准
- •Previous left atrial ablation.
- •Patient's opposition to participating in this registry
结局指标
主要结局
long-term efficacy (AA)
时间窗: within 1-year period post-procedure
freedom from all types of atrial arrhythmia recurrences
very long-term efficacy (AA)
时间窗: Within 2 years period post-procedure
freedom from all types of atrial arrhythmia recurrences
次要结局
- 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)