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
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.
研究概览
地位
条件
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Tianyou Ling
- 电话号码：+8618930235117
- 邮箱：lty11498@rjh.com.cn
学习地点
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Shanghai Municipality
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Shanghai、Shanghai Municipality、中国
- Ruijin Hostpial Shanghai Jiaotong University School of Medicine
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参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器：Pulsed Field Ablation with a catheter for Pulmonary Vein Isolation
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Pulsed Field Ablation (PFA) using a commercially available pulsed field ablation catheter to perform pulmonary vein isolation (PVI).
Ablation is performed sequentially at each pulmonary vein and the pulmonary vein antrum, with the procedural endpoint of durable bidirectional electrical isolation.
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实验性的：Pulsed Field Ablation with a catheter for Pulmonary Vein Isolation plus Superior Vena Cava Isolation
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Pulsed Field Ablation (PFA) using a commercially available pulsed field ablation catheter to perform pulmonary vein isolation (PVI) followed by electrophysiological assessment for superior vena cava (SVC) triggers and additional superior vena cava isolation (SVCI) at the SVC-right atrium junction.
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
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Treatment success from 3 months after the ablation (after the blanking period) through the 12-month follow-up
大体时间：3 months after the ablation (after the blanking period) through the 12-month follow-up
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3 months after the ablation (after the blanking period) through the 12-month follow-up
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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Incidence of atrial fibrillation (AF), atrial tachycardia (AT), or atrial flutter (AFL) during the 3-month blanking period after the index ablation
大体时间：From the index ablation through 3 months after the index ablation
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From the index ablation through 3 months after the index ablation
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Time to first recurrence of atrial fibrillation (AF), atrial tachycardia (AT), or atrial flutter (AFL)
大体时间：From the index ablation through 12 months after the index ablation
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From the index ablation through 12 months after the index ablation
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Change in quality of life from baseline, as assessed by the Atrial Fibrillation Effect on Quality-of-Life (AFEQT)
大体时间：From baseline through 12 months after the index ablation
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From baseline through 12 months after the index ablation
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Change in quality of life from baseline, as assessed by the Atrial Fibrillation Effect on 12-Item Short Form Health Survey (SF-12) scores
大体时间：From baseline through 12 months after the index ablation
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From baseline through 12 months after the index ablation
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Incidence of cardiovascular-related rehospitalization
大体时间：From the index ablation through 12 months after the index ablation
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From the index ablation through 12 months after the index ablation
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Proportion of participants undergoing repeat catheter ablation
大体时间：From the index ablation through 12 months after the index ablation
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From the index ablation through 12 months after the index ablation
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Composite of perioperative complications and serious adverse events (SAEs) within 30 days after the index ablation
大体时间：From the index ablation through 30 days after the index ablation
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From the index ablation through 30 days after the index ablation
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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