Reduction of Fluoroscopy Exposure During Atrial Fibrillation Ablation (AF-FII)
Atrial Fibrillation Ablation Facilitated by Fluoroscopy Image Integrated 3-dimentional Electroanatomical Mapping System
研究概览
详细说明
The novel fluoroscopic image integrated 3-dimentional electroanatomical mapping system is designed for minimizing the exposure to X-ray for physician, staff and patients. This randomized single-center study is to evaluate the reduction on fluoroscopy levels (time and dosis) in catheter interventional treatment of symptomatic, antiarrhythmic refractory paroxysmal atrial fibrillation using fluoroscopic image integrated 3-dimentional electroanatomical mapping system, comparing with using 3-dimentional electroanatomical mapping system without fluoroscopic image integration. Patients with documented paroxysmal atrial fibrillation, who are going to receive a catheter interventional treatment to atrial fibrillation, will be randomized (1:1) into two groups after signing an informed consent. Group 1 (CARTOUNIVU): using fluoroscopic image integrated 3-dimentional electroanatomical mapping system. Group 2 (CARTO3): using 3-dimentional electroanatomical mapping system without fluoroscopic image integration.
The ablation strategies in both study groups are the same, including circumferential isolation of ipsilateral pulmonary veins (PV) and voltage map guided substrate modification. According to the randomization, the ablation procedure will be performed with or without fluoroscopic image integration.
The primary endpoint of this study is the evaluation of reduction on fluoroscopy levels (fluoroscopy time and dosis) during atrial fibrillation ablation procedure. Secondary endpoints include complete isolation of the pulmonary veins, completely bidirectional block of linear ablation lines, total procedure time, ablation-related complications.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Saxony
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Dresden、Saxony、德国、01307
- Department of Electrophysiology, University of Dresden - Heart Center
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- documented atrial fibrillation in the 12-lead ECG or Holter ECG
- Paroxysmal symptomatic atrial fibrillation
- Ineffectiveness of antiarrhythmic medication ( at least 1 medication )
- Age 18-75 years
- left atrial diameter <60 mm ( Transesophageal Echocardiography, parasternal )
- A signed consent form
Exclusion Criteria:
- Reversible etiology of atrial fibrillation
- Pregnancy
- Women of childbearing potential without a negative pregnancy test within 48 hours prior to the ablation procedure
- Intracardiac thrombus
- Contraindication to anticoagulation
- Thromboembolic event in the last 6 months
- Previous left atrial ablation
学习计划
研究是如何设计的?
设计细节
- 主要用途:预防
- 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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实验性的:CARTOUNIVU
Radiofrequency catheter ablation of atrial fibrillation will be performed using fluoroscopy image integrated 3-dimentional electroanatomical mapping system
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Radio-frequency atrial fibrillation catheter ablation includes circumferential PV isolation and voltage-map guided substrate modification, which means low voltage zone (amplitude < o.5 mV) will also be ablated.
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有源比较器:CARTO3
Radiofrequency catheter ablation of atrial fibrillation will be performed using 3-dimentional electroanatomical mapping system without fluoroscopy image integration technique
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Radio-frequency atrial fibrillation catheter ablation includes circumferential PV isolation and voltage-map guided substrate modification, which means low voltage zone (amplitude < o.5 mV) will also be ablated.
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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 |
|---|---|---|
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Fluoroscopy time for each step of atrial fibrillation ablation procedure
大体时间:1 day ( at the end of each step of atrial fibrillation ablation procedure)
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Fluoroscopy time will be recorded at the end of each step of atrial fibrillation ablation, including femoral vein puncture, placement of catheters, transseptal puncture, system registration, reconstruction of left atrium, PV-Angiography, acquirement of voltage map, PV-isolation, confirmation of complete PV isolation and linear ablations.
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1 day ( at the end of each step of atrial fibrillation ablation procedure)
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Fluoroscopy doses for each step of atrial fibrillation ablation procedure
大体时间:1 day ( at the end of each step of atrial fibrillation ablation procedure)
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Fluoroscopy doses will be recorded at the end of each step of atrial fibrillation ablation, including femoral vein puncture, placement of catheters, transseptal puncture, system registration, reconstruction of left atrium, PV-Angiography, acquirement of voltage map, PV-isolation, confirmation of complete PV isolation and linear ablations.
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1 day ( at the end of each step of atrial fibrillation ablation procedure)
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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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Number of patients with adverse events as a measure of safety
大体时间:All patients will be followed for the duration of hospital stay for acute complications, an expected average of 3 days.
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Perforation, tamponed, phrenic nerve injury and oesophagus injury (patients will be screened for oesophagus injury for a month after atrial fibrillation ablation), etc.
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All patients will be followed for the duration of hospital stay for acute complications, an expected average of 3 days.
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Number of patients with a failure of reaching endpoints of procedure as a measure of efficacy
大体时间:1 day ( at the end of each step of atrial fibrillation ablation procedure)
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number of pulmonary veins/linear ablation lines has not been completely isolated/blocked at the end of the AF ablation
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1 day ( at the end of each step of atrial fibrillation ablation procedure)
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Total time of atrial fibrillation ablation procedure as a measure of efficacy
大体时间:up to 24 hours
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procedure time (minute)
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up to 24 hours
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合作者和调查者
调查人员
- 首席研究员:Christopher Piorkowski, M.D.、Department of Electrophysiology, University of Dresden - Heart Center
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- EK474122013
- CARTOUNIVU (其他赠款/资助编号:Biosense Webster)
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