Clinical Usefulness of Virtual Ablation Guided Catheter Ablation of Atrial Fibrillation: Prospective Randomized Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- change of hospitalization rate
研究概览
简要总结
Radiofrequency catheter ablation is highly effective in the treatment of patients with persistent atrial fibrillation. In order to decrease the recurrence rate after catheter ablation, the investigators propose to apply 'virtual' ablation on patient-specific atria by simulating 3D atrial computer model. The investigators will test with five different set of ablation methods and find successful methods for a specific patient. Then, this result will be compared to empirical catheter ablation result by randomly controlled trial.
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
- Single (Investigator)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of AF patients who performed catheter ablation of atrial fibrillation due to uncontrolled pulse rate by anti-arrhythmic drug therapy.
排除标准
- •AF patients who have severe heart deformations or blood problems.
- •The patients who had been performed catheter ablation of atrial ablation.
- •The patients who missed out to recording of 3D CT, echo and electrocardiography.
研究组 & 干预措施
virtual simulation
This intervention group is to choose the best effective method operation to patients by simulating 3D atrial computer model which consider patient's heart size and shape.
干预措施: Virtual ablation in based 3D CT of patient who diagnosed AF (Procedure)
conventional ablation
The other intervention group is to operate the atrial fibrillation by physician's personal experience, not by virtual simulation.
干预措施: conventional ablation based on physician's personal experience (Procedure)
结局指标
主要结局
change of hospitalization rate
时间窗: 1, 3, 6, 12, 18 and 24 months after catheter ablation and every 6 months thereafter.
次要结局
- occurence of cardiovascular disease(6 months)
- recurrence of AF(6 months)