Pulsed Field Ablation for the Treatment of Persistent Atrial Fibrillation: Pulmonary Vein Plus Superior Vena Cava Isolation Versus Pulmonary Vein Isolation Alone-A Prospective, Multicenter, Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 340
- 试验地点
- 1
- 主要终点
- Treatment success from 3 months after the ablation (after the blanking period) through the 12-month follow-up
研究概览
简要总结
his study is for people aged 18 to 75 who have persistent atrial fibrillation (AFib) that has lasted less than one year and who are having their first catheter ablation procedure.
Atrial fibrillation is a common heart rhythm problem. A standard treatment is a catheter procedure called pulmonary vein isolation (PVI), which uses energy to disconnect the pulmonary veins from the rest of the heart. However, in persistent AFib, the heart rhythm often returns after PVI alone.
Some people also have abnormal electrical signals coming from a large vein above the right atrium called the superior vena cava (SVC). This study tests whether adding SVC isolation (SVCI) to the standard PVI procedure works better than PVI alone.
The study will use pulsed field ablation (PFA), a newer non-heating technology that targets heart muscle cells and may cause less damage to nearby structures such as the food pipe and nerves.
About 340 participants will be enrolled from around 10 hospitals in China. Using a computer process, half will be assigned to PVI alone and half to PVI plus SVC isolation. Neither the doctor nor the participant will be blinded to the group assignment because the difference between the two procedures is visible.
All participants will be followed for 12 months after the procedure. The main question is: after a 3-month healing period, how many people stay free from AFib and other atrial rhythm problems for the remaining 9 months without needing more ablation or new rhythm medicines? The study also looks at safety, quality of life, hospital stays, and whether the heart rhythm returns.
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
- •Persistent atrial fibrillation (AFib) duration < 1 year;
- •Age 18-75 years;
- •Willing to participate in this study, capable of understanding, and has signed the informed consent form; able to complete postoperative follow-up according to the protocol.
排除标准
- •Significant cardiac dysfunction or structural abnormality: LVEF < 50% or left atrial anteroposterior diameter > 46 mm;
- •Previous left atrial ablation or cardiac surgery (including left atrial appendage closure);
- •Presence of permanent pacemaker, CRT, implantable cardiac monitor, or any type of ICD;
- •Previous pulmonary vein stent, pulmonary vein stenosis, or superior vena cava stenosis;
- •Previous unilateral phrenic nerve palsy;
- •Any prosthetic heart valve or moderate-to-severe (grade 3-4) valvular regurgitation/stenosis;
- •Any cardiac surgery, myocardial infarction, PCI/PTCA, or coronary stent implantation within 3 months prior to signing informed consent;
- •Unstable angina, NYHA class III/IV heart failure, primary pulmonary hypertension, rheumatic heart disease, or hypertrophic cardiomyopathy;
- •Thrombocytosis/thrombocytopenia, any disease contraindicating long-term anticoagulation, active systemic infection;
- •Atrial fibrillation due to reversible causes (e.g., hyperthyroidism);
- •Stroke or TIA within 6 months prior to signing informed consent;
- •Pregnant or lactating women;
- •Life expectancy < 1 year;
- •Currently participating in or expected to participate in another drug/device/biologic clinical trial during the study period;
- •Intracardiac thrombus, drug or alcohol addiction, unwillingness or inability to complete follow-up;
- •Severe renal insufficiency (eGFR < 30);
- •Previous catheter ablation for atrial fibrillation;
- •Primary severe sick sinus syndrome.
研究组 & 干预措施
Pulsed Field Ablation with a catheter for Pulmonary Vein Isolation
干预措施: Pulsed Field Ablation - pulmonary vein isolation (Device)
Pulsed Field Ablation with a catheter for Pulmonary Vein Isolation plus Superior Vena Cava Isolation
干预措施: Pulsed Field Ablation - Pulmonary Vein Isolation + Superior Vena Cava Isolation (Device)
结局指标
主要结局
Treatment success from 3 months after the ablation (after the blanking period) through the 12-month follow-up
时间窗: 3 months after the ablation (after the blanking period) through the 12-month follow-up
次要结局
- Change in quality of life from baseline, as assessed by the Atrial Fibrillation Effect on 12-Item Short Form Health Survey (SF-12) scores(From baseline through 12 months after the index ablation)
- Incidence of atrial fibrillation (AF), atrial tachycardia (AT), or atrial flutter (AFL) during the 3-month blanking period after the index ablation(From the index ablation through 3 months after the index ablation)
- Time to first recurrence of atrial fibrillation (AF), atrial tachycardia (AT), or atrial flutter (AFL)(From the index ablation through 12 months after the index ablation)
- Change in quality of life from baseline, as assessed by the Atrial Fibrillation Effect on Quality-of-Life (AFEQT)(From baseline through 12 months after the index ablation)
- Incidence of cardiovascular-related rehospitalization(From the index ablation through 12 months after the index ablation)
- Proportion of participants undergoing repeat catheter ablation(From the index ablation through 12 months after the index ablation)
- Composite of perioperative complications and serious adverse events (SAEs) within 30 days after the index ablation(From the index ablation through 30 days after the index ablation)