A Comparative Study of Percutaneous Pulsed Field Ablation Guided by Ultrasound Alone Versus Fluoroscopy in Patients With Atrial Fibrillation
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 276
- 主要终点
- Success rate of complete electrical isolation of pulmonary veins during the procedure
研究概览
简要总结
This prospective, randomized, multicenter, open-label, non-inferiority interventional study aims to compare the therapeutic efficacy of percutaneous pulsed field ablation (PFA) guided by ultrasound alone versus fluoroscopy in patients with paroxysmal atrial fibrillation (AF). The success rate of complete electrical isolation of pulmonary veins during the procedure was compared to verify that ultrasound-only guidance is non-inferior to fluoroscopic guidance.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Adult patients aged 18 to 75 years (including 18 years and 75 years of age).
- •Patients diagnosed with paroxysmal atrial fibrillation via 12-lead electrocardiography or ambulatory electrocardiography and scheduled to undergo pulsed field ablation.
- •Subjects are able to understand the purpose of the study, voluntarily participate in the study and sign the informed consent, and are willing to complete the follow-up according to the requirements of the program.
排除标准
- •Atrial fibrillation secondary to electrolyte imbalance, thyroid disorders, or reversible non-cardiac causes;
- •Previous history of catheter ablation or cardiac surgery for atrial fibrillation;
- •Prior surgical history including patent foramen ovale closure, atrial septal defect closure or repair;
- •Implantation of left atrial appendage occluder, mechanical mitral valve prosthesis, or valvuloplasty ring containing metallic materials;
- •Concomitant other tachyarrhythmias requiring catheter ablation (e.g., atrioventricular reentrant tachycardia, atrioventricular nodal reentrant tachycardia, atrial tachycardia, atrial flutter, Wolff-Parkinson-White syndrome, etc.);
- •Persistent atrial fibrillation;
- •Left atrial anteroposterior diameter (LAD) > 55 mm on transthoracic echocardiography;
- •Women who are pregnant, breastfeeding, or of childbearing age with plans to become pregnant during the clinical trial;
- •Current participation in another pharmaceutical or medical device clinical study.
研究组 & 干预措施
Percutaneous pulsed field ablation performed under ultrasound-only guidance.
Percutaneous pulsed field ablation is performed under ultrasound-only guidance in patients with paroxysmal atrial fibrillation.
干预措施: Percutaneous pulsed field ablation is performed under ultrasound-only guidance in patients with paroxysmal atrial fibrillation. (Procedure)
Pulsed field ablation performed under fluoroscopic guidance
Patients with paroxysmal atrial fibrillation underwent percutaneous pulsed field ablation under fluoroscopic guidance.
干预措施: Patients with paroxysmal atrial fibrillation underwent percutaneous pulsed field ablation under fluoroscopic guidance. (Procedure)
结局指标
主要结局
Success rate of complete electrical isolation of pulmonary veins during the procedure
时间窗: Immediately post-procedure
The proportion of all pulmonary veins maintaining bidirectional block across ablation lines at 20 minutes after ablation completion.
次要结局
- Compare the procedural time and DSA fluoroscopy time between the two groups.(Immediately post-procedure)
- The incidence of complications within 30 days after the procedure(Within 30 days post-procedure)
- Success rate of atrial fibrillation ablation at 12 months post-procedure.(12 months post-procedure)
- The proportion of patients admitted to hospital or emergency departments due to atrial fibrillation recurrence within 12 months after the procedure.(12 months post-procedure)
- The proportion of patients who received electrical cardioversion due to atrial fibrillation recurrence within 12 months after the procedure(12 months post-procedure)
- The proportion of patients undergoing repeat ablation surgery owing to atrial fibrillation within 12 months after the procedure(12 months post-procedure)
- The proportion of patients who resumed antiarrhythmic drug therapy during follow-up after the blanking period(From the end of the blanking period (within 90 days after catheter ablation) to 12 months post-procedure)
- Improvement in the total EQ-5D quality-of-life questionnaire score at 12 months post-procedure compared with baseline(12 months post-procedure)
- Statistical analysis was performed to evaluate differences in fluoroscopic exposure dose between the two groups.(Immediately post-procedure)
- Compare the length of hospital stay and postprocedural ICU/CCU stay duration between the two groups.(through study completion, an average of 1 year)
- Compare the differences in costs between the two groups, including medical equipment costs, personnel costs, and patient hospitalization expenses.(through study completion, an average of 1 year)