Prospective, Multicenter, Randomized Controlled Study on the Therapeutic Value of Additional Left Atrial Posterior Wall Isolation Guided by Voltage Mapping in Persistent Atrial Fibrillation.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 350
- 试验地点
- 1
- 主要终点
- 12-month atrial fibrillation (AF) ablation success rate
研究概览
简要总结
This prospective, multicenter, randomized controlled study was designed to investigate the feasibility, efficacy and safety of pulsed field ablation (PFA) strategies for persistent atrial fibrillation. For patients with persistent atrial fibrillation and normal left atrial substrate, pulmonary vein isolation combined with superior vena cava isolation will be performed. For those with abnormal left atrial substrate, two strategies will be adopted: pulmonary vein isolation plus superior vena cava isolation, and pulmonary vein isolation combined with superior vena cava isolation and left atrial posterior wall isolation. Long-term follow-up will be conducted to observe the long-term clinical outcomes.
详细描述
No other detailed description.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Older than 18 years.
- •Diagnosed as persistent atrial fibrillation (AF); Definition: At least one episode of persistent AF was recorded on dynamic electrocardiogram (ECG) data within 12 months prior to enrollment, or other clinical evidence supporting persistent AF episodes lasting more than 7 days.
- •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 is secondary to thyroid disease or other reversible factors.
- •Evidence of left atrial or left atrial appendage thrombus on imaging examination.
- •Rheumatic heart disease or the presence of moderate to severe mitral stenosis or regurgitation.
- •Left ventricular ejection fraction <40% or New York Heart Association (NYHA) class III/IV.
- •Left atrial anteroposterior diameter >55 mm.
- •Unstable angina.
- •Myocardial infarction (MI), coronary artery bypass grafting (CABG), or percutaneous coronary intervention (PCI) within 3 months prior to enrollment.
- •Previous catheter ablation or surgical ablation for atrial fibrillation.
- •History of prior left atrial appendage closure, patent foramen ovale closure, atrial septal defect closure, or repair surgery.
- •Implantation of a mechanical mitral valve prosthesis or metallic annuloplasty rings.
- •Presence of intracardiac thrombus, space-occupying lesions, or other abnormalities that preclude vascular access or catheter manipulation.
- •Contraindications to anticoagulation or history of coagulation disorders/abnormal bleeding.
- •Active systemic infection.
- •Estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m² or history of renal dialysis.
- •Severe hepatic dysfunction.
- •Pregnancy or breastfeeding.
- •Life expectancy <12 months (e.g., advanced malignancy).
- •Current or anticipated participation in other drug or device clinical trials.
- •Any other condition or abnormality deemed by the investigator to warrant exclusion.
研究组 & 干预措施
superior vena cava isolation
Left atrial substrate mapping is performed after pulmonary vein ablation. For patients with abnormal left atrial substrate, superior vena cava isolation and left atrial posterior wall isolation will be conducted in the experimental group.
干预措施: superior vena cava isolation (Procedure)
superior vena cava and left atrial posterior wall isolation
Left atrial substrate mapping is performed following pulmonary vein ablation. For patients with abnormal left atrial substrate, superior vena cava and left atrial posterior wall isolation will be carried out in the control group.
干预措施: superior vena cava isolation (Procedure)
superior vena cava and left atrial posterior wall isolation
Left atrial substrate mapping is performed following pulmonary vein ablation. For patients with abnormal left atrial substrate, superior vena cava and left atrial posterior wall isolation will be carried out in the control group.
干预措施: Abnormal left atrial substrate (Procedure)
结局指标
主要结局
12-month atrial fibrillation (AF) ablation success rate
时间窗: 12 months post-procedure
Defined as the absence of AF, atrial flutter (AFL), or atrial tachycardia (AT) episodes ≥30 seconds on dynamic electrocardiogram (ECG) monitoring after the blanking period (90 days post-catheter ablation)
次要结局
- The postoperative quality of life was assessed using the Atrial Fibrillation-Specific Quality of Life Scale.(Within 12 months post-procedure)
- Acute pulmonary vein ablation success rate and superior vena cava isolation rate.(Immediately post-procedure)
- Immediate Success Rate of Left Atrial Posterior Wall Ablation (Abnormal Substrate Group Only)(Immediately post-procedure)
- Procedure-related time(Immediately post-procedure)
- Early recurrence rate of atrial arrhythmia (within the blanking period)(Within 3 months post-procedure)
- Incidence of symptomatic and asymptomatic atrial fibrillation events after the end of the blanking period.(Within 12 months post-procedure)
- Incidence of repeat ablation after the blanking period(Within 12 months post-procedure)
- Rate of maintenance of pulmonary vein 、left atrial posterior wall and superior vena cava isolation in patients undergoing repeat ablation.(Within 12 months post-fist procedure.)
- Improvement in Atrial fibrillation burden.(3、6 and 12 months post-procedure.)
- Cardiac function assessment by NYHA(within 12 months post-procedure)