NCT02438176已完成不适用
Comparison of Single Groin and Single Trans-septal Puncture and Conventional Bilateral Groin Puncture and Double Trans-septal Puncture in Catheter Ablation for Atrial Fibrillation
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 105
- 试验地点
- 2
- 主要终点
- Patient's subjective discomfort
研究概览
简要总结
The purpose of this study is to compare single groin puncture and bilateral groin puncture during AF ablation procedure. The investigators will compare 1) the degree of patients' discomfort during hemostasis by questionaire, 2) procedure time, 3) complication rates, and 4) 1-year clinical recurrence rate of AF.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients agreement of consent
- •Patients who age more than 19
- •patients who undergoing catheter ablation of atrial fibrillation
- •Patients who are not vascular disease
排除标准
- •patients who do not agree with study inclusion
- •persistent AF
- •Patients with vascular disease or venous anomaly
- •Patients with structural abnormality of the heart
研究组 & 干预措施
single puncture group
Experimental
single trans-septal puncture
干预措施: single trans-septal puncture (Procedure)
conventional group
Active Comparator
conventional bilateral groin puncture
干预措施: conventional bilateral groin puncture (Procedure)
结局指标
主要结局
Patient's subjective discomfort
时间窗: 6month after procedure
次要结局
- Procedure related complication rate(1 month after procedure)
- Procedure time(1day)
- Long-term AF recurrence rate(12 month after procedure)
研究者
研究点 (2)
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