A Study Evaluating the Effectiveness and Safety of Pulsed Field Ablation Using the FARAPULSE™ System for Electrical Isolation of Pulmonary Veins and Superior Vena Cava
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
- 主要终点
- PVI and SVCI
研究概览
简要总结
This study is a prospective, single-center, single-arm clinical trial planning to screen and enroll 200 subjects. It aims to evaluate the efficacy and safety of pulsed field ablation (PFA) using the FARAPULSE™ system for pulmonary vein isolation (PVI) and superior vena cava isolation (SVCI) in Chinese patients with paroxysmal atrial fibrillation (PAF). Baseline preoperative data, along with intraoperative and postoperative follow-up information, will be collected. The primary endpoint is the proportion of subjects achieving successful PVI and SVCI using solely the FARAPULSE™ PFA system. Secondary endpoints include long-term procedural success rates and various procedural parameters. Additionally, the incidence of adverse events will be recorded as safety endpoints. The study adopts a single-arm target value design hypothesis, and research data will also be compared with historical data from patients treated with radiofrequency ablation for PVI and SVCI to further evaluate the efficacy of PFA. Subgroup analysis will be conducted in patients with heart failure to assess the efficacy and safety of PFA in this population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 75 years.
- •Documented diagnosis of paroxysmal atrial fibrillation (PAF), defined as typical AF electrographic characteristics (absence of P waves with irregular fibrillatory waves) recorded on 12-lead ECG or symptomatic Holter monitoring, with each episode lasting less than 7 days.
- •Symptomatic despite attempted antiarrhythmic drug therapy.
- •Scheduled to undergo initial catheter ablation procedure.
- •Voluntarily provided written informed consent.
排除标准
- •AF secondary to electrolyte imbalance, thyroid disorders, or other reversible/non-cardiac causes.
- •Persistent atrial fibrillation.
- •Presence of persistent left superior vena cava.
- •Contraindications to pulsed field ablation (e.g., left atrial appendage thrombus, post-atrial septal defect device closure, permanent metallic implants in the left atrium) or contraindications to anticoagulant therapy.
- •Unsuitable for deep sedation/anesthesia per operator assessment.
- •Life expectancy less than 1 year.
- •Other conditions deemed inappropriate for inclusion by the investigator.
研究组 & 干预措施
Pulsed Field Ablation
Using the FARAPULSE™ System
干预措施: Pulsed Field Ablation (Device)
结局指标
主要结局
PVI and SVCI
时间窗: Periprocedural
The proportion of subjects achieving successful PVI and SVCI using solely the FARAPULSE™ PFA system
次要结局
- Long-term procedural success rates(From the end of the 3-month blanking period post-ablation to the 12-month follow-up)
- Perioperative complications(From the end of the ablation to the 12-month follow-up)