NCT02097758招募中不适用
Efficacy of Three Dimensional Transesophageal Echocardiography for Percutaneous Device Closure in Atrial Septal Defect
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Successful device implantation
研究概览
简要总结
Background: Three-dimensional echocardiographic image for atrial septal defect (ASD) is useful for evaluation of defect size and shape. The investigators suggested optimal device size using three-dimensional transesophageal echocardiographic image and our formula in previous study.
Purpose: In this study, the investigators seek to predict the correct device size and confirm the accuracy of the formula that we made before device closure in ASD patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 year-old
- •Susceptible indication for atrial septal defect closure
- •Potential candidate for device closure
排除标准
- •Poor candidate for device closure: multiple ASDs, ect
- •Other heart disease requiring open heart surgery
研究组 & 干预措施
transcatheter device closure
Experimental
Choosing device size using three dimensional image and the formula without sizing balloon
干预措施: Transcatheter device closure (Device)
结局指标
主要结局
Successful device implantation
时间窗: 1 day
次要结局
- Procedure time(during procedure)
研究者
Jong-Min Song
Professor
Asan Medical Center
研究点 (1)
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