Long Term Results of 450 Percutaneous Closures of PDA in a Single Center
Percutaneous closure is one of the methods used to treat, among other congenital heart disorder, Persistent Ductus Arteriosus (PDA) in children and adults. During the years 1998-2013 four hundred and fifty patients were catheterized in the department of pediatric cardiology and congenital heart diseases in Rambam health care campus, using various devices.
In this retrospective research, the investigators analyze data from patients' medical files, to estimate and define the correlation between the patients' demographic and morphologic data to the type and size of chosen closure device.
Aim of study:
To create an algorithm that can be used to choose the proper device for percutaneous closure of the PDA, based on the characteristics of the patient and the PDA type.
研究概览
地位
条件
详细说明
The investigators analyze the demographic characteristics of patients before the procedure (Age, gender, weight, height, co-morbidities etc.), the type and characteristics of PDA and the chosen device, success and failure rates of the procedure, and adverse effects.
The data is taken from patients' medical files - based on medical reports regarding physical examination, blood tests and imaging studies including cineangiograms and echo-doppler studies.
研究类型
注册 (实际的)
联系人和位置
学习地点
-
-
-
Haifa、以色列、31096
- Rambam Health Care Center
-
-
参与标准
资格标准
适合学习的年龄
- 孩子
- 成人
- 年长者
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- All the patients that underwent percutaneous closure of PDA between January 1998 and august 2013 in the department of pediatric cardiology and congenital heart diseases in Rambam health care campus
Exclusion Criteria:
- None
学习计划
研究是如何设计的？
设计细节
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Success of implantation
大体时间：one day, 10 days and a year after PDA closure and then last check-up exam
|
due to the fact that the research is retrospective and refers to a period of 15 years (1998-2013)and the fact that some patients had a check-up exam from time to time - the investigators have decided to include in this research the last check-up exam as well.
|
one day, 10 days and a year after PDA closure and then last check-up exam
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
residual shunt
大体时间：one day, 10 days and a year after PDA closure and then last check-up exam
|
due to the fact that the research is retrospective and refers to a period of 15 years (1998-2013) and the fact that some patients had a check-up exam from time to time - the investigators have decided to include in this research the last check-up exam as well.
|
one day, 10 days and a year after PDA closure and then last check-up exam
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Early and late Adverse effects
大体时间：one day, 10 days and a year after PDA closure and then last check-up exam
|
hemolysis, bleeding, infections ect.
due to the fact that the research is retrospective and refers to a period of 15 years (1998-2013)and the fact that some patients had a check-up exam from time to time - the investigators have decided to include in this research the last check-up exam as well.
|
one day, 10 days and a year after PDA closure and then last check-up exam
|
合作者和调查者
调查人员
- 首席研究员：Moshe Dotan, MD、Rambam Health Care Campus
- 首席研究员：Omer Ephrat、Rambam Health Care Campus
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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