Procedural Outcomes of Percutaneous PDA Closure: Comparative Study Between Different Devices.
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 主要终点
- Procedural safety
研究概览
简要总结
To compare safety, efficacy and procedural outcome of percutaneous PDA closure using different approaches for better characterization of device selection criteria.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 1 Month 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •all patients who are candidate for transcatheter PDA closure
排除标准
- •Patients with PDA dependent pulmonary circulation.
- •Patients with small sized PDA which is silent by auscultation
- •Patients with large sized PDA which is unsuitable for Trans-catheter closure
- •Patients with PDA and severe irreversible pulmonary hypertension (Eisenmenger's syndrome) (7).
- •Patients with active infection or active infective endarteritis.
- •Patients refusing the study.
结局指标
主要结局
Procedural safety
时间窗: one month
studying the occurrence of catheter related complications including 1. Occurrence of vascular access hematoma(Yes/No ) 2. Occurrence of contrast induced nephropathy (Yes/No) 3. PDA closure Device embolization (Yes/No) 4. Cardiac tamponade (Yes/No)
Procedural efficacy
时间窗: one month
timing of complete closure of the PDA with no residual shunts 1. Residual left to right shunt (Yes/No) 2. Degree of the residual shunt (Trace, Mild , Moderate, severe) 3. Timing of closure of the shunt( immediately postprocedural, 24 hours post procedural , 1 month post procedural )
Procedural outcomes
时间窗: one month
comparison of echocardiography data that will be done pre catheter closure, one day post procedure and one month later ( left ventricular and atrial dimensions-left ventricular ejection fraction-pulmonary artery systolic pressure- degree of tricuspid regurge)
次要结局
未报告次要终点
研究者
Ahmed Mohamed Moheb El-Din
Assistant lecturer of cardiovascular medicine
Assiut University