NCT05015764已完成不适用
Reprieve Cardiovascular System for the Treatment of Subjects With Acute Decompensated Heart Failure Mechanistic Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Device and Procedure related AEs and SAEs
研究概览
简要总结
Reprieve Cardiovascular System for the Treatment of Subjects with Acute Decompensated Heart Failure Mechanistic Study
详细描述
The key objective of the trial was to provide an optimized decongestion treatment for subjects with acute decompensated heart failure and identify the critical parameters that could be incorporated into the design of the next generation of the Reprieve Cardiovascular System.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hospitalized with a diagnosis of heart failure
- •Patients ≥ 18 years of age able to provide informed consent and comply with study procedures.
排除标准
- •Inability to place Foley catheter or IV catheter
- •Hemodynamic instability
- •Dyspnea due primarily to non-cardiac causes
- •Acute infection with evidence of systemic involvement
- •Inability to follow instructions or comply with follow-up procedures.
- •Other concomitant disease or condition that investigator deems unsuitable for the study
- •Enrollment in another interventional trial during the index hospitalization
- •Life expectancy less than 3 months
结局指标
主要结局
Device and Procedure related AEs and SAEs
时间窗: Through study completion, an average of 90 days
Rate of device and procedure related AEs and SAEs
Fractional Excretion of Sodium measured during therapy
时间窗: End of treatment, an average of 24 hours
Average fractional excretion of sodium across all patients measured during therapy
次要结局
未报告次要终点
研究者
研究点 (1)
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