Efficacy and Safety of Superior Vena Cava Isolation and Pulmonary Vein Isolation for Treatment of Atrial Fibrillation (SAVE-AF)
2026年7月23日 更新者：Qiang Hu
Efficacy and Safety of Superior Vena Cava Isolation in Addition to Pulmonary Vein Isolation by Pulsed Field Ablation for Treatment of Atrial Fibrillation
Atrial fibrillation (AF) is one of the most concerning diseases in the field of cardiac arrhythmias.
It is a type of rapid supraventricular arrhythmia characterized by rapid and disorganized contraction of the atria, which leads to ventricular rate disturbance, impaired cardiac function, and an increased risk of atrial mural thrombus formation.
AF severely reduces patients' quality of life and can cause complications such as heart failure, stroke, and sudden death.
Currently, the vast majority of AF episodes are triggered by pulmonary vein (PV) ectopic foci.
Therefore, catheter ablation is the preferred treatment strategy, with pulmonary vein isolation (PVI) being the cornerstone procedure.
However, a small proportion of patients may have non-PV triggers, particularly originating from the superior vena cava (SVC).
Conventional radiofrequency ablation (RFA) for SVC isolation carries unpredictable risks, including damage to the sinus node and the phrenic nerve.
Therefore, this study aims to investigate the impact of empirical SVC electrical isolation in addition to PVI on the success rate of AF ablation, using pulsed field ablation (PFA)-a non-thermal ablation modality with tissue selectivity and a favorable safety profile.
研究概览
地位
招聘中
条件
研究类型
介入性
注册 (估计的)
200
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Qiang Hu, Doctor
- 电话号码：+8602886590223
- 邮箱：huqiang071@foxmail.com
学习地点
-
-
Sichuan
-
Chengdu、Sichuan、中国、610000
- 招聘中
- Qiang Hu
-
接触：
- Qiang Hu, Doctor
- 电话号码：+8602886590223
- 邮箱：huqiang071@foxmail.com
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
Inclusion Criteria:
- Age ≥ 18 years;
- Patients with documented atrial fibrillation (AF), confirmed by at least one episode of AF recorded on a 12-lead surface electrocardiogram (ECG) or ambulatory ECG monitoring within the past 12 months;
- Subjects who agree to undergo treatment for AF using a pulsed field ablation (PFA) system that is currently commercially available in China;
- Patients who have shown an inadequate response to, or intolerance of, at least one class of antiarrhythmic drug therapy;
- Subjects or their legally authorized representatives who have been informed of the nature of this study, have agreed to all terms and conditions of the study, and have provided written informed consent, and who are willing to complete all required clinical follow-up visits in accordance with the study protocol.
Exclusion Criteria:
- Prior surgical or catheter ablation for any type of cardiac arrhythmia;
- AF secondary to electrolyte imbalance, valvular heart disease, thyroid disease, or other reversible causes;
- Known requirement for ablation outside the pulmonary vein ostia or beyond the cavotricuspid isthmus;
- Sinus node dysfunction or other indications for permanent pacemaker implantation;
- Myocardial infarction, or prior coronary artery bypass grafting (CABG) or percutaneous coronary intervention (PCI) within the past 6 months;
- Left atrial anteroposterior diameter ≥ 50 mm;
- Evidence of left atrial or left atrial appendage thrombus confirmed by transesophageal echocardiography (TEE) or left atrial computed tomography (CT) within 24 hours prior to the procedure;
- Serum creatinine > 2 times the upper limit of normal, or currently on dialysis;
- History of prior cardiothoracic surgery;
- History of permanent pacemaker implantation;
- History of malignancy;
- Long-term use of a central venous catheter;
- Contraindications to anticoagulation therapy (including allergy to anticoagulants, thrombocytopenia, severe bleeding tendency, or coagulation disorders);
- History of allergy to contrast;
- Women who are pregnant, lactating, or who are unwilling to use adequate contraception during the study period;
- Subjects or their legally authorized representatives who are unwilling to provide written informed consent;
- Subjects who, for any reason, are unable to comply with the study protocol or complete all required clinical follow-up visits;
- Subjects deemed by the investigator to be unsuitable for PFA treatment of AF.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
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：三倍
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：superior vena cava isolation plus pulmonary vein isolation
|
Eligible patients with atrial fibrillation who are randomized to the experimental group will undergo superior vena cava (SVC) electrical isolation in addition to pulmonary vein isolation (PVI) during the pulsed field ablation procedure
|
|
有源比较器：pulmonary vein isolation
|
Eligible patients with atrial fibrillation who are randomized to the control group will undergo pulmonary vein isolation (PVI) during the pulsed field ablation procedure
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
the success rate of atrial fibrillation ablation
大体时间：at 3 month
|
it is assessed by 7-day Holter monitoring
|
at 3 month
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
the success rate of atrial fibrillation ablation
大体时间：at 6 month and 12 month
|
it is assessed by 7-day Holter monitoring
|
at 6 month and 12 month
|
|
left ventricular end-systolic diameter
大体时间：at 3 month, 6 month and 12 month
|
it is measured by echocardiography
|
at 3 month, 6 month and 12 month
|
|
left ventricular end-diastolic diameter
大体时间：at 3 month, 6 month and 12 month
|
it is measured by echocardiography
|
at 3 month, 6 month and 12 month
|
|
left ventricular posterior wall thickness
大体时间：at 3 month, 6 month and 12 month
|
it is measured by echocardiography
|
at 3 month, 6 month and 12 month
|
|
interventricular septal thickness
大体时间：at 3 month, 6 month and 12 month
|
it is measured by echocardiography
|
at 3 month, 6 month and 12 month
|
|
left ventricular ejection fraction
大体时间：at 3 month, 6 month and 12 month
|
it is measured by echocardiography
|
at 3 month, 6 month and 12 month
|
|
E/A
大体时间：at 3 month, 6 month and 12 month
|
it is measured by echocardiography
|
at 3 month, 6 month and 12 month
|
|
E/e'
大体时间：at 3 month, 6 month and 12 month
|
it is measured by echocardiography
|
at 3 month, 6 month and 12 month
|
|
left atrial volume index
大体时间：at 3 month, 6 month and 12 month
|
it is measured by echocardiography
|
at 3 month, 6 month and 12 month
|
|
left atrial anteroposterior diameter
大体时间：at 3 month, 6 month and 12 month
|
it is measured by echocardiography
|
at 3 month, 6 month and 12 month
|
|
left atrial strain
大体时间：at 3 month, 6 month and 12 month
|
it is measured by echocardiography
|
at 3 month, 6 month and 12 month
|
|
New York Heart Association class
大体时间：at 3 month, 6 month and 12 month
|
The NYHA is measured by Classification of NYHA heart function
|
at 3 month, 6 month and 12 month
|
|
Major adverse events
大体时间：at 3 month, 6 month and 12 month
|
Major adverse events is a composite endpoint of death, stroke, and myocardial infarction.
|
at 3 month, 6 month and 12 month
|
|
6-min walk distance
大体时间：at 3 month, 6 month and 12 month
|
During the test, patients were asked to walk for 6 minutes on a long corridor with a length of 37.5 meters between the 2 marks
|
at 3 month, 6 month and 12 month
|
|
red blood cell count
大体时间：at 3 month, 6 month and 12 month
|
It is obtained from the routine blood test.
|
at 3 month, 6 month and 12 month
|
|
hemoglobin
大体时间：at 3 month, 6 month and 12 month
|
It is obtained from the routine blood test.
|
at 3 month, 6 month and 12 month
|
|
white blood cell count
大体时间：at 3 month, 6 month and 12 month
|
It is obtained from the routine blood test.
|
at 3 month, 6 month and 12 month
|
|
platelet count
大体时间：at 3 month, 6 month and 12 month
|
It is obtained from the routine blood test.
|
at 3 month, 6 month and 12 month
|
|
alanine aminotransferase
大体时间：at 3 month, 6 month and 12 month
|
It is obtained from the liver function test.
|
at 3 month, 6 month and 12 month
|
|
aspartate aminotransferase
大体时间：at 3 month, 6 month and 12 month
|
It is obtained from the liver function test.
|
at 3 month, 6 month and 12 month
|
|
creatinine
大体时间：at 3 month, 6 month and 12 month
|
It is obtained from the renal function test
|
at 3 month, 6 month and 12 month
|
|
urea
大体时间：at 3 month, 6 month and 12 month
|
It is obtained from the renal function test
|
at 3 month, 6 month and 12 month
|
|
estimated glomerular filtration rate
大体时间：at 3 month, 6 month and 12 month
|
It is obtained from the renal function test
|
at 3 month, 6 month and 12 month
|
|
activated partial thromboplastin time
大体时间：at 3 month, 6 month and 12 month
|
It is obtained from the coagulation function test
|
at 3 month, 6 month and 12 month
|
|
prothrombin time
大体时间：at 3 month, 6 month and 12 month
|
It is obtained from the coagulation function test
|
at 3 month, 6 month and 12 month
|
|
international normalized ratio
大体时间：at 3 month, 6 month and 12 month
|
It is obtained from the coagulation function test
|
at 3 month, 6 month and 12 month
|
|
B-type natriuretic peptide
大体时间：at 3 month, 6 month and 12 month
|
It is obtained from a blood sample.
|
at 3 month, 6 month and 12 month
|
|
Atrial Fibrillation Effect on Quality of Life Questionnaire
大体时间：at 3 month, 6 month and 12 month
|
AFEQT questionnaire was used to assess the quality of life of patients with atrial fibrillation.
|
at 3 month, 6 month and 12 month
|
|
readmission
大体时间：at 3 month, 6 month and 12 month
|
Rehospitalization was indicated for atrial fibrillation.
|
at 3 month, 6 month and 12 month
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
赞助
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2026年7月20日
初级完成 (估计的)
2029年3月31日
研究完成 (估计的)
2029年3月31日
研究注册日期
首次提交
2026年7月21日
首先提交符合 QC 标准的
2026年7月21日
首次发布 (实际的)
2026年7月24日
研究记录更新
最后更新发布 (实际的)
2026年7月27日
上次提交的符合 QC 标准的更新
2026年7月23日
最后验证
2026年7月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.