NCT05240638已完成不适用
Feasibility of Transcatheter Cannulation and Drainage of the Thoracic Duct in Patients With Congestive Heart Failure
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1
- 试验地点
- 2
- 主要终点
- Technical success for access
研究概览
简要总结
This study aims to test the safety and efficacy of lymph fluid drainage on heart congestion and shortness of breath symptoms among patients participants with heart failure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Age 18 years or older
- •Subjects with informed consent to participate
- •NYHA III- IV patients
- •Patients with heart failure volume overload
- •Planned for elective right heart catheterization
排除标准
- •Active coronary syndrome (type I myocardial infarction)
- •Local infection or ongoing systemic infection(s)
- •Thrombotic coagulation disorder
- •On continuous blood thinners that cannot be discontinued or held
- •Allergy or contraindications to the use of iodine-based contrast agents
- •Subjects deemed to be high risk for performing a cardiac catheterization by study investigator
结局指标
主要结局
Technical success for access
时间窗: At the time of the procedure
Number of patients where TD was accessed successfully with an endovascular catheter under fluoroscopic or ultrasound guidance
Safety defined as the absence of serious adverse events
时间窗: Up to 24 hours post-procedure
Safety as measured by number of serious adverse events
Technical success for drainage
时间窗: At the time of the procedure
Number of patients where any amount of lymph was drained successfully from the TD with an endovascular catheter
次要结局
- Number of HF-related hospitalizations as measured by medical record review(30 days post-discharge)
- Total fluid output (measured in mL) as measured by fluid collection(Up to 24 hours post-procedure)
- Change in body weight(Pre-procedure, Post-procedure (up to 4 hours))
- Change in blood N-terminal Pro-BNP as measured by lab test(Baseline, 12 hours, 24 hours post initiation of drainage)
研究者
研究点 (2)
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