NCT03234647已完成不适用
First In Human Study of the Doraya Catheter for the Treatment of AHF Patients
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 9
- 试验地点
- 7
- 主要终点
- Device or procedure related Serious Adverse Event (SAE) rate through 60 days
研究概览
简要总结
Safety and performance evaluation of the Doraya catheter in patients admitted with AHF.
详细描述
The purpose of this clinical investigation is to evaluate the safety and performance of the Doraya catheter in patients admitted with AHF, presenting persistent volume over load and poor response to diuretic treatment.
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
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •AHF subjects with poor diuretic response
排除标准
- •AHF subjects with sufficient diuretic response
结局指标
主要结局
Device or procedure related Serious Adverse Event (SAE) rate through 60 days
时间窗: 60 days
SAE as defined by ISO 14155
次要结局
未报告次要终点
研究者
研究点 (7)
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