Reveal LINQ™ Evaluation of Fluid
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 9
- 试验地点
- 2
- 主要终点
- Change in Subcutaneous Impedance
研究概览
简要总结
The purpose of this study is to investigate the use of subcutaneous impedance measured with an implanted Medtronic Reveal LINQ™ insertable cardiac monitor for use as a fluid status monitor in hemodialysis patients. The study will measure the changes in subject subcutaneous impedance and compare with the fluid status assessed by the volume removed from the hemodialysis subject during dialysis sessions. Subcutaneous impedance trends will also be evaluated between dialysis sessions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who currently undergo in-clinic hemodialysis treatment prescribed 2 or 3 times per week
- •Patients willing to be implanted with the Reveal LINQ™ device
- •Patients greater than 21 years of age
- •Patients willing and able to comply with the study procedures including giving informed consent
排除标准
- •Patient has an active implanted cardiac medical device (e.g. IPG, ICD, CRT, etc)
- •Patients who currently undergo home dialysis treatment
- •Patient is enrolled in another study that could confound the results of this study, without documented pre-approval from a Medtronic study manager.
- •Patient with a recent infection defined as 1) bacteremia within 60 days OR 2) (nonbacteremic) infection within 14 days
- •Patient not suitable for Reveal LINQ™ implantation (e.g., severe cachexia, dermatologic conditions of the skin, or major medical or social conditions expected to reduce survival to < 6 months), in the opinion of the investigator
研究组 & 干预措施
Diagnostic
'Reveal LINQ™ Insertable Cardiac Monitor' will be used to measure changes in subject subcutaneous impedance and compare with the fluid status assessed by the volume removed from the hemodialysis subject during dialysis sessions.
干预措施: Reveal LINQ™ Insertable Cardiac Monitor (Device)
结局指标
主要结局
Change in Subcutaneous Impedance
时间窗: 24 days
The change in impedance from the beginning to the end of a dialysis session, averaged over all patients and dialysis sessions
Average Fluid Volume Removed
时间窗: 24 Days
The average fluid volume removal during the dialysis session over all patients.
次要结局
未报告次要终点