Atrial Fibrillation Ablation Facilitated by Fluoroscopy Image Integrated 3-dimentional Electroanatomical Mapping System
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Fluoroscopy time for each step of atrial fibrillation ablation procedure
研究概览
简要总结
To evaluate reduction of fluoroscopy time/dosis and safety of atrial fibrillation ablation in patients with paroxysmal atrial fibrillation using fluoroscopy image integrated 3-dimentional electroanatomical mapping system, comparing to using 3-dimentional electroanatomical mapping system without fluoroscopy image integration
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •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
排除标准
- •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
研究组 & 干预措施
CARTOUNIVU
Radiofrequency catheter ablation of atrial fibrillation will be performed using fluoroscopy image integrated 3-dimentional electroanatomical mapping system
干预措施: Radio-frequency catheter ablation (Device)
CARTO3
Radiofrequency catheter ablation of atrial fibrillation will be performed using 3-dimentional electroanatomical mapping system without fluoroscopy image integration technique
干预措施: Radio-frequency catheter ablation (Device)
结局指标
主要结局
Fluoroscopy time for each step of atrial fibrillation ablation procedure
时间窗: 1 day ( at the end of each step of atrial fibrillation ablation procedure)
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.
Fluoroscopy doses for each step of atrial fibrillation ablation procedure
时间窗: 1 day ( at the end of each step of atrial fibrillation ablation procedure)
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.
次要结局
- Number of patients with adverse events as a measure of safety(All patients will be followed for the duration of hospital stay for acute complications, an expected average of 3 days.)
- Total time of atrial fibrillation ablation procedure as a measure of efficacy(up to 24 hours)
- Number of patients with a failure of reaching endpoints of procedure as a measure of efficacy(1 day ( at the end of each step of atrial fibrillation ablation procedure))
研究者
Christopher Piorkowski
M.D.
Technische Universität Dresden