NCT05759806招募中不适用
Safety and Performance Evaluation of the Nephronyx System for the Treatment of Patients With ADHF
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 10
- 试验地点
- 5
- 主要终点
- Serious Adverse Events
研究概览
简要总结
The objective of this interventional study is to evaluate the safety and functional performance of the Nephronyx System in patients with ADHF, presenting clinical signs of volume overload and compromised response to diuretics.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient admitted to the hospital with a primary diagnosis of ADHF
- •Patient has signs of volume overload as evidence by a score of ≥ 4 on the EVEREST score
- •Patient with Left Ventricular Ejection Fraction LVEF >15%
- •Patient has compromised response to diuretics
- •NT-proBNP >450 pg/mL if aged <55 years, >900 pg/mL if aged between 55 and 75 years and >1800 pg/mL if aged >75 years
排除标准
- •Patient with active DVT or history of DVT
- •Patient has documented or evidence of Renal artery stenosis
- •BMI>35 Kg/m^2
- •Patient has documented, untreated symptomatic coronary artery disease (CAD) requiring revascularization
- •Patient is in Cardiogenic shock
- •Patient has blood dyscrasia, acute anemia, thrombocytopenia, bleeding diathesis, or coagulopathy
- •Temperature > 38°C, or sepsis, or active systemic infection requiring IV anti-microbial treatment
- •Patient has shown liver cirrhosis or has signs of liver damage
研究组 & 干预措施
ADHF patients
Experimental
ADHF patients with compromised response to diuretics treated with Nephronyx system
干预措施: Nephronyx system (Perfuser) (Device)
结局指标
主要结局
Serious Adverse Events
时间窗: 24 hours post device retrieval
Device and/or investigational procedure related SAEs
Performance/ Procedural success
时间窗: procedure day
Device preforms as planned with no associated device malfunction
次要结局
未报告次要终点
研究者
研究点 (5)
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