Randomized Comparison Between 3 D CT Overlay and Conventional Fluoroscopy to Decrease Contrast and Radiation Exposure During Cryoballoon Ablation for Atrial Fibrillation
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Fluoroscopy time
研究概览
简要总结
Cryoablation using a balloon is an effective therapy for paroxysmal atrial fibrillation (AF), however associated with significant amounts of radiation exposure and contrast medium use. A new imaging technique (3D CT overlay) could reduce radiation exposure and contrast medium use significantly.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients screened are accepted for PVI according to the current guidelines - Patients are candidates for enrolment if they have paroxysmal AF as defined in the guidelines
排除标准
- •Persistent, long-standing persistent or permanent AF
- •Left atrial diameter > 50 mm (measured in the parasternal long axis, as assessed with transthoracic echocardiography)
- •Previous PVI ablation (epicardial or endocardial).
研究组 & 干预措施
Standard fluorscopy
Cryoablation using a balloon with standard fluoroscopy
干预措施: Cryoablation (Device)
3D CT overlay
Cryoablation using a balloon with 3D CT overlay
干预措施: Cryoablation (Device)
结局指标
主要结局
Fluoroscopy time
时间窗: Procedure time
To compare the fluoroscopy time between cryoballoon ablation with and without the use of 3D CT overlay
radiation exposure
时间窗: Procedure time
To compare the radiation exposure (DAP) between cryoballoon ablation with and without the use of 3D CT overlay
Contrast
时间窗: Amount of contrast during procedure
To compare the amount of contrast medium between cryoballoon ablation with and without the use of 3D CT overlay
次要结局
- Recurrence(one year)
研究者
B. Oude Velthuis
cardiologist
Medisch Spectrum Twente