Introductory Clinical Trial for Measuring Patients Before, During, and After an Electrophysiology (EP) Procedure With a Novel, Body-Worn Sensor
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Average Change in Respiratory Rate (RR)
研究概览
简要总结
Subjects will be consented to wear the CoVa-2 monitoring system prior to (baseline), during, and after an Electrophysiology Procedure (EP). During this time, the system will measure the following parameters from subjects: heart rate (HR), Heart Rate Variability (HRV), respiration rate (RR), and Cardiac Output (CO). Data will be retrospectively analyzed to determine if the system effectively operates under these conditions, and can effectively monitor subjects and allow them to be discharged early from the hospital. Subjects will not be measured while transferred in and out of the operating room. Approximate sample size is 20 subjects.
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
- •Patients with arrhythmias and other cardiac conditions that are scheduled for EP procedures.
- •Subject is over 22 years of age at the time of consenting
- •Subject and/or legally authorized representative is willing to undergo the informed consent process prior to enrollment in the study
排除标准
- •Pregnant subjects
- •Subjects who are participating in another clinical study that may affect the results of either study
- •Subjects who are unwilling or unable to wear the sensor (and electrodes) for a period of up to 14 hours
- •Subjects who are considered by the principle investigator to be medically unsuitable for study participation
研究组 & 干预措施
EP Procedure
Patient will continuously wear the CoVa-2 monitoring system until they are discharged. During this period, data from the sensor will be sent to the Gateway and Cloud-based System, and then analyzed retrospectively.
干预措施: CoVa-2 Monitoring System (Diagnostic Test)
结局指标
主要结局
Average Change in Respiratory Rate (RR)
时间窗: Baseline, 8 Hours
RR data is retrospectively analyzed from the CoVa-2 monitoring system, and the average change in RR (prior to the start of EP (baseline) to completion of EP (8 hours)) is reported.
Average Change in Heart Rate (HR)
时间窗: Baseline, 8 Hours
HR data is retrospectively analyzed from the CoVa-2 monitoring system, and the average change in HR (prior to the start of EP (baseline) to completion of EP (8 hours)) is reported.
次要结局
未报告次要终点