Safety and Efficacy of EchoNavigator System Release II During Structural Heart Interventions (EchoNav)
Safety and Efficacy of EchoNavigator System Release II (Philips, Andover, MA) During Structural Heart Interventions
研究概览
详细说明
EchoNavigator System Release II is a CE certified innovative periinterventional imaging modality used in our clinic of cardiology, pulmonology and angiology during structural heart interventions like transfemoral aortic valve Implantation (TAVI), MitraClip implantation, patent foramen ovale (PFO), atrial septal defect (ASD) and left atrial appendage (LAA). During this interventions EchoNavigator is able to combine live X-ray Images and 3D Echo guidance to enhance the efficiency of the procedure.
Specific periprocedural data parameter, e.g. procedure duration, radiation time, radiation dose, transseptal punction time (e.g.LAA) and contrast agent amount will be collected and analysed. The same data characteristics from the same procedures but without the periinterventional use of the EchoNavigator System Release II will be collected, analysed and compared with the data described above. A retrospective data collection between 2013 - 2017 of n=500 patients will be conducted.
研究类型
注册 (预期的)
联系人和位置
学习地点
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Dusseldorf、德国、40225
- Division of Cardiology, Pulmonary Disease and Vascular Medicine
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参与标准
资格标准
适合学习的年龄
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:
- Adult male or female patients of any ethnic origin aged > 18 years
- Signed and dated informed consent for the prospective study part
Exclusion Criteria:
- < 18 year
学习计划
研究是如何设计的？
设计细节
- 观测模型：其他
- 时间观点：追溯
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
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Data analysis transfemoral aortic valve implantation
Periinterventional data analysis during structural heart procedures like transfemoral aortic valve implantation with and without the use of EchoNavigator System Release II.
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data parameters Analysis
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Data analysis MitraClip
Periinterventional data analysis during structural heart procedures like MitraClip Implantations with and without the use of EchoNavigator System Release II.
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data parameters Analysis
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Data analysis PFO
Periinterventional data analysis during structural heart procedures like PFO implantations with and without the use of EchoNavigator System Release II.
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data parameters Analysis
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Data analysis ASD
Periinterventional data analysis during structural heart procedures like ASD implantations with and without the use of EchoNavigator System Release II.
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data parameters Analysis
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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 |
|---|---|---|
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Comparison of procedure time
大体时间：baseline
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During interventions with and without the use of EchoNavigator System Release II
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baseline
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Comparison of area dose product
大体时间：baseline
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During procedures with and without the use of EchoNavigator System Release II
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baseline
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Comparison of contrast agent amount
大体时间：baseline
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During procedures with and without the use of EchoNavigator System Release II
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baseline
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Comparison of data measurements of fluoroscopy time
大体时间：baseline
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During procedures with and without the use of EchoNavigator System Release II
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baseline
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Comparison of duration of the transeptal punction
大体时间：baseline
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During mitraClip implantations, ASD/PFO with and without the use of EchoNavigator System Release II.
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baseline
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合作者和调查者
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 (预期的)
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 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- EchoNav
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