Clinical Usefulness of Virtual Ablation Guided Catheter Ablation of Atrial Fibrillation: Virtual Rotor Mapping and Catheter Ablation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 110
- 试验地点
- 2
- 主要终点
- Recurrence rate of atrial fibrillation of 18 months after procedure within 18 months
研究概览
简要总结
Radiofrequency catheter ablation is effective in the treatment of patients with paroxysmal atrial fibrillation. In order to reduce 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 conduct virtual rotor mapping in the patient specific atrial model. Then, the investigators will compare the clinical outcome of conventional circumferential pulmonary vein isolation and additional rotor ablation guided by virtual rotor mapping.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •AF patient age 19~80
- •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 vascular disease.
- •The patient who have renal disease of eGFR<30mL/min
- •The patients who had been performed catheter ablation of atrial ablation and MAZE.
- •The patients who missed out to recording of 3D CT, echo and electrocardiography.
- •the patient have experienced major hemorrhagic complication
- •The patient have experienced ischemic cerebral infarction more 2 times
- •The patient who have risk of ischemic cerebral infarction (CHA2DS2-VASc Score >5)
结局指标
主要结局
Recurrence rate of atrial fibrillation of 18 months after procedure within 18 months
时间窗: 18 months
Rate of mortality, incidence of cerebral infarction and hospitalization after procedure
时间窗: 24 months
次要结局
- Pericardial effusion required treatment, 4g/dL reduced level of Hb, Hemorrhage required blood transfusion and Cerebral infarction related procedure(24 months)
- Procedure time and Radiofrequency ablation time(24 months)
- Major complication related procedure : Complication of hemorrhagic and embolic(24 months)