Performance of Masimo INVSENSOR00057 in Detecting Atrial Fibrillation (Afib)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 139
- 试验地点
- 2
- 主要终点
- Sensitivity of INVSENSOR00057 Atrial Fibrillation (Afib) Detection Function
研究概览
简要总结
This study is designed to validate the performance of Masimo INVSENSOR00057 in detecting atrial fibrillation. The noninvasive ECG measurements will be compared to results obtained from an FDA-cleared ECG 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
- Other
- 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
- 是
入选标准
- •Subject is 18 years of age or older.
- •Subject is confirmed to have active atrial fibrillation at the time of enrollment.
排除标准
- •Subject is confirmed to have concurrent active arrhythmias (e.g., PVCs, bradycardia, etc.) at the time of enrollment.
- •Subject is allergic to adhesives or ECG gel.
- •Subject whose skin is not intact in or at the vicinity of the device placement site.
结局指标
主要结局
Sensitivity of INVSENSOR00057 Atrial Fibrillation (Afib) Detection Function
时间窗: 1-5 hours
Afib detection accuracy will be determined by analyzing the sensitivity of INVSENSOR00057 Afib detection function when compared to data collected using a FDA-cleared ECG monitor.
Specificity of INVSENSOR00057 Atrial Fibrillation (Afib) Detection Function
时间窗: 1-5 hours
Afib detection accuracy will be determined by analyzing the specificity of INVSENSOR00057 Afib detection function when compared to data collected using a FDA-cleared ECG monitor.
次要结局
未报告次要终点