NCT00583596已完成不适用
Closure Of Patent Ductus Arteriosus With the AMPLATZER Duct Occluder the AMPLATZER® Duct Occluder
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 436
- 试验地点
- 46
- 主要终点
- Reporting of Late Adverse Events Relating to the Device.
研究概览
简要总结
AGA-004 - The objective of the study is to determine safety, effectiveness and clinical utility of the AMPLATZER Duct Occluder in patients with patent ductus arteriosus. AGA-007 - The objective of this study is to evaluate the long term safety and effectiveness issues that may not have have been adequately addressed during AGA-004.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Months 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with a demonstrated patent ductus arteriosus
- •Body weight > 5 Kilograms
排除标准
- •Pulmonary vascular resistance above 8 Woods units or a Rp/Rs >0.
- •Additional cardiac or non-cardiac abnormality that can reasonably be expected to significantly affect the patient's health adversely in the next two years, i.e.: cancer, Eisenmenger's syndrome, other serious congenital heart disease.
- •Pelvic vein or inferior vena cava thrombosis
- •Sepsis (local/generalized) or any type of infection that cannot be successfully treated prior to device placement.
- •History of repeated pulmonary infection
- •Demonstrated intracardiac thrombi on echocardiography • Inability to obtain informed consent
结局指标
主要结局
Reporting of Late Adverse Events Relating to the Device.
时间窗: Long term follow up for data captured at 5, 6 or 7 years post implant
Reporting of Late Efficacy Issues Regarding Patent Ductus Arteriosis (PDA) Closure
时间窗: Long term follow up data captured at 5, 6 or 7 years post implant
The number of participants with a residual shunt (efficacy)
次要结局
未报告次要终点
研究者
研究点 (46)
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