NCT02828735已完成不适用
REspiration Patterns in REVEAL LINQ Insertable Cardiac Monitor
Medtronic BRC1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2017年1月30日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- feasibility of respiration detection
研究概览
简要总结
The purpose of the study is to evaluate the use of subcutaneous impedance measured with an implanted Medtronic Reveal LINQ™ insertable cardiac monitor (ICM) as respiratory rate monitor.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Suspected arrhythmia Diastolic Heart Failure and/or in Renal Failure.
- •Chronic Kidney Disease (CKD) in Stage 5 (GFR = <15 mL/min).
- •Diastolic Heart Failure in class II and class III (class IV to be considered in end stage and non-reversible).
- •Willing to sign the informed consent form.
- •Greater than 18 years of age.
排除标准
- •Enrolled in another study that could confound the results of this study, without documented pre-approval from a Medtronic study manager.
- •Significant respiratory diseases such as COPD or pulmonary hypertension.
- •Frequent arrhythmias, including PVC's.
- •Known systolic heart failure.
- •Recent infection.
- •Allergenic or rejection reaction to materials used in incision/insertion tools, Reveal LINQ™ ICM exterior or incision closure method.
- •Active implanted cardiac medical device (e.g. IPG, ICD, CRT, etc).
- •Not suitable for Reveal LINQ™ implantation (e.g., severe cachexia, dermatologic conditions of the skin) or any concomitant condition which in the opinion of the investigator would not allow a safe participation in the study.
- •Body conditions that would complicate accurate measurement of respiratory efforts with an external device deployed around the chest.
- •Not able to take the postures as necessary for the study protocol and not able to walk continuously for a period of 6 minutes.
- •Any concomitant condition which in the opinion of the investigator would not allow a safe participation in the study.
研究组 & 干预措施
Respiration assessment
Other
干预措施: respiration assessment (Device)
结局指标
主要结局
feasibility of respiration detection
时间窗: up to 18 months
Respiratory Maneuvers and Device interrogation
次要结局
未报告次要终点
研究者
研究点 (1)
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