A Study on the Therapeutic Value of Additional Left Atrial Posterior Wall Isolation Guided by Voltage Mapping in Persistent Atrial Fibrillation.
2026年5月12日 更新者：Hangzhou Dinova EP Technology Co., Ltd
Prospective, Multicenter, Randomized Controlled Study on the Therapeutic Value of Additional Left Atrial Posterior Wall Isolation Guided by Voltage Mapping in Persistent Atrial Fibrillation.
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.
研究概览
详细说明
No other detailed description.
研究类型
介入性
注册 (估计的)
350
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：GUODONG NIU
- 电话号码：+86 0871-68279999
- 邮箱：guodniu@163.com
学习地点
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Yunnan
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Kunming、Yunnan、中国
- Fuwai Yunnan Hospital
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接触：
- Guodong Niu, PhD
- 电话号码：+860871-68279999
- 邮箱：guodniu@163.com
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-
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
是的
描述
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
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：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：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.
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Left atrial substrate mapping is performed after pulmonary vein ablation.
For patients with abnormal left atrial substrate, superior vena cava isolation isolation will be conducted in the experimental group.
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有源比较器：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.
|
Left atrial substrate mapping is performed after pulmonary vein ablation.
For patients with abnormal left atrial substrate, superior vena cava isolation isolation will be conducted in the experimental group.
Left atrial substrate mapping is performed following pulmonary vein ablation.
For patients with abnormal left atrial substrate, superior vena cava isolation will be carried out in the control group.
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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 |
|---|---|---|
|
12个月的房颤（AF）消融成功率
大体时间：后期12个月
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定义为没有AF，心房颤动（AFL）或心脏心动过速（AT）发作≥30秒的动态心电图（ECG）监测（后导管后90天）进行监测（ECG）
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后期12个月
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Acute pulmonary vein ablation success rate and superior vena cava isolation rate.
大体时间：Immediately post-procedure
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Twenty minutes after completion of ablation, under three-dimensional electroanatomical mapping, the ablated area presents as an electrically silent region (voltage < 0.1 mV).
Alternatively, a circular mapping catheter or ablation catheter is positioned within the ablation line: (1) disappearance of intracatheter potentials within the ablation line (entrance block); (2) no local potential capture during pacing of the pulmonary veins and superior vena cava, or local potential capture without subsequent conduction exit (exit block).
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Immediately post-procedure
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Immediate Success Rate of Left Atrial Posterior Wall Ablation (Abnormal Substrate Group Only)
大体时间：Immediately post-procedure
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Twenty minutes after completion of ablation, the ablated area presented as an electrically silent zone (voltage < 0.1 mV) under three-dimensional electroanatomic mapping; no local potential capture was achieved during posterior wall pacing.
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Immediately post-procedure
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Procedure-related time
大体时间：Immediately post-procedure
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Total procedure time, catheter manipulation time, pulse discharge time, total fluoroscopy time.
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Immediately post-procedure
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Early recurrence rate of atrial arrhythmia (within the blanking period)
大体时间：Within 3 months post-procedure
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Early recurrence rate of atrial arrhythmia (within the blanking period)
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Within 3 months post-procedure
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Incidence of symptomatic and asymptomatic atrial fibrillation events after the end of the blanking period.
大体时间：Within 12 months post-procedure
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Incidence of symptomatic and asymptomatic atrial fibrillation events after the end of the blanking period
|
Within 12 months post-procedure
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Incidence of repeat ablation after the blanking period
大体时间：Within 12 months post-procedure
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Incidence of repeat ablation after the blanking period
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Within 12 months post-procedure
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Rate of maintenance of pulmonary vein 、left atrial posterior wall and superior vena cava isolation in patients undergoing repeat ablation.
大体时间：Within 12 months post-fist procedure.
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Rate of maintenance of pulmonary vein 、left atrial posterior wall and superior vena cava isolation in patients undergoing repeat ablation.
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Within 12 months post-fist procedure.
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Improvement in Atrial fibrillation burden.
大体时间：3、6 and 12 months post-procedure.
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Evaluate the improvement in postoperative atrial fibrillation burden via ambulatory electrocardiography.
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3、6 and 12 months post-procedure.
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Cardiac function assessment by NYHA
大体时间：within 12 months post-procedure
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Cardiac function was assessed relative to baseline using the NYHA classification.
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within 12 months post-procedure
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The postoperative quality of life was assessed using the Atrial Fibrillation-Specific Quality of Life Scale.
大体时间：Within 12 months post-procedure
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Assess the improvement in health-related quality of life after atrial fibrillation surgery using the Atrial Fibrillation Effect on QualiTy of Life score.
|
Within 12 months post-procedure
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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。
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 (估计的)
2026年4月30日
初级完成 (估计的)
2029年2月1日
研究完成 (估计的)
2029年2月1日
研究注册日期
首次提交
2026年4月20日
首先提交符合 QC 标准的
2026年5月12日
首次发布 (实际的)
2026年5月15日
研究记录更新
最后更新发布 (实际的)
2026年5月15日
上次提交的符合 QC 标准的更新
2026年5月12日
最后验证
2026年5月1日
更多信息
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