Comparison of Different Pulsed Field Ablation Catheters Combined With Stroke Prevention in High Stroke Risk·Atrial Fibrillation: A Prospective, Multicenter, Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 292
- 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
Pulsed field energy ablation, a non-thermal ablation modality, can potentially reduce post-ablation tissue edema. Previous studies have confirmed the feasibility and safety of combined pulsed field ablation (PFA) and left atrial appendage closure (LAAC) as a one-stop treatment, with few reports of post-ablation tissue edema. However, during PFA procedures, the presence of metallic components in the ablation site (e.g., occluder frames, metallic valves) may lead to arcing during energy delivery, compromising procedural safety. Therefore, when performing PFA+LAAC as a one-stop procedure, a "ablation-first" strategy is recommended. Due to the influence of parameters such as voltage, pulse width, and number of cycles on pulsed field energy characteristics, significant variability in ablation depth and area may exist between different PFA devices. To date, no large-scale clinical studies have compared the efficacy and safety of different PFA systems. Accordingly, this study will conduct a prospective, multicenter, randomized controlled trial to compare the effectiveness and safety of domestic versus imported pulsed field ablation catheters in the treatment of patients with atrial fibrillation.
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
- 118 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Older than 18 years.
- •Diagnosed with drug-refractory, symptomatic atrial fibrillation.
- •The patient has a high risk of stroke (CHA2DS2-VA score ≥ 2).
- •Have a situation of:
- •requires oral anticoagulation therapy
- •high bleeding risk (HAS-BLED score ≥ 3) that unsuitable for or unwilling to undergo long-term oral anticoagulation therapy.
- •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
- •History of persistent atrial fibrillation >1 year.
- •Atrial fibrillation was secondary to thyroid disease or other reversible reasons.
- •Left atrial anteroposterior diameter >50 mm.
- •Evidence of left atrial or left atrial appendage thrombus on imaging examination.
- •Concurrent other arrhythmias required for catheter ablation (e.g., atrioventricular reentrant tachycardia, atrioventricular nodal reentrant tachycardia, pre-excitation syndrome) prior to enrollment.
- •Rheumatic heart disease.
- •Left ventricular ejection fraction <40% or New York Heart Association (NYHA) class III/IV.
- •Unstable angina.
- •Myocardial infarction (MI), coronary artery bypass grafting (CABG), or percutaneous coronary intervention (PCI) within 3 months prior to enrollment.
- •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.
- •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.
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
- Acute pulmonary vein ablation success rate(Immediately post-procedure)
- Incidence of major adverse events (MAEs) related to the device(Within 7 days post-procedure)
- Incidence of repeat ablation(Within 12 months post-procedure)
- AF burden(6 and 12 months post-procedure)
- Incidence of cardiovascular MAEs(Within 12 months post-procedure)
- Technical success rate of LAAC(Immediately post-procedure)
- LAA closure rate(3 and 6 months post-procedure)
- Incidence of new residual shunt(3 and 6 months post-procedure)
- Incidence of device-related thrombus(Within 12 months post-procedure.)
- Discontinuation rate of anticoagulants and antiarrhythmic medications(Within 12 months post-procedure)