NCT02337790已完成不适用
Necklace-Shaped Sensor for Non-Invasive Monitoring of Fluids, Heart Rate, Heart Rate Variability, and Respiration Rate in Patients With a Pacemaker, Implanted Cardioverter-Defibrillator, or Ventricular Assist Device
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 109
- 试验地点
- 1
- 主要终点
- Number of Patients with Interference between implanted devices and CoVa Monitoring System
研究概览
简要总结
This study is designed to validate the use of the CoVa Monitoring System in subjects with implanted devices.
详细描述
The study had the following objectives:
- Verify that the CoVa Monitoring System does not interfere with implanted devices.
- Verify that implanted devices do not interfere with the functions of the CoVa Monitoring System.
- Verify that the CoVa Monitoring System fits on a wide variety of body types.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is between 21 (twenty-one) and 95 (ninety-five) years of age at screening.
- •Subject has a pacemaker, implanted cardioverter-defibrillator, or ventricular assist device.
- •Subject and/or legally authorized person/representative is willing to undergo the Informed Consent process prior to enrollment in the study.
- •Subject is a candidate for this study based on the PI's opinion and knowledge of the subject's condition.
排除标准
- •Subject is participating in another clinical study that may affect the results of either study.
- •Subject is unable or not willing to wear electrode patches as required.
- •Subject has skin sensitivity to adhesive or hydrogel materials used in electrode patches.
- •Subject is considered by the PI to be medically unsuitable for study participation.
结局指标
主要结局
Number of Patients with Interference between implanted devices and CoVa Monitoring System
时间窗: One time for up to 15 minutes during a clinic visit for device interrogation
次要结局
未报告次要终点
研究者
研究点 (1)
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