Proof of Concept Study for 1 Lead Patch Technology
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Composite Outcome Measure - 100% Successful ECG Acquisition
研究概览
简要总结
This study is intended to assess the feasibility and usability of the 1 Lead Patch as a whole, on patients outside the hospital, in the out-patient setting.
详细描述
This study is a two-phase evaluation of the use of a 1 Lead Patch System to monitor electrocardiogram (ECG) data and send the data to the LifeWatch Service Center, in the same manner as the existing ACT ambulatory telemetry system. It will be used in parallel with the standard 3 Lead ACT testing equipment used to monitor ECG outside the hospital. This study will not address safety or effectiveness and no comparator groups will be used. This study will not be treating any particular disease or condition and no randomization or blinding is required. Subjects will be selected in conjunction with their need for current outpatient telemetry monitoring.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- 是
入选标准
- •Adult male or female referred for 3 Lead ACT monitoring for between 7 and 14 days.
- •Be recently prescribed a LifeWatch 3 Lead ACT monitor
排除标准
- •under 21-years old
- •pregnant or who may become become pregnant during the investigation period
- •using internal or external defibrillators
- •who are using pacemakers or implantable loop recorders
- •showing skin damage on the chest, such as burns, irritation, infections, wounds, etc.
- •meeting any contraindications for a patch biosensor
研究组 & 干预措施
1-Lead Outpatient Telemetry
1-Lead Outpatient Patch study participants. Patients assigned to outpatient telemetry monitoring will receive the 1-Lead patch upon discharge from hospital inpatient status. ECG data will be submitted by the 1-lead patch to a central database.
干预措施: 1-Lead Patch (Device)
结局指标
主要结局
Composite Outcome Measure - 100% Successful ECG Acquisition
时间窗: Between 7 and 14 days
Successful acquisition of ECG data by the 1-Lead patch with transmission to the central database via the gateway. Each patch includes a 'brain' that collects the ECG data and then transmits it to a cellular device called the 'gateway'. The gateway uses the cellular network to transmit the data to the central database. This is a composite outcome measure. Data were not collected.
次要结局
- Composite Outcome Measure - Adhesive Performance - Measurement of Skin Irritation Resulting From Adhesive Used With 1-Lead Patch(Between 7 and 14 days)