NCT05476250终止不适用
Clinical Performance of Masimo INVSENSOR00057 for Atrial Fibrillation Detection
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Specificity of Masimo INVSENSOR00057 Atrial Fibrillation 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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The subject is 18 to 80 years of age.
- •Subject can read and communicate in English.
- •Subject's cardiac rhythm shall be Normal Sinus Rhythm or Atrial Fibrillation (Afib). This determination will be made using FDA cleared 3-lead ECG which will label subject's cardiac rhythm as such.
排除标准
- •Subject has open wounds, inflamed tattoos or piercings on the area of device placement, and/or has any visible healing wounds that the investigator and/or medical professional determines may place them at an increased risk for participation.
- •Subject has any medical condition which in the judgment of the investigator and/or study staff, renders them ineligible for participation in this study or subject is deemed ineligible by the discretion of the investigator/study staff.
结局指标
主要结局
Specificity of Masimo INVSENSOR00057 Atrial Fibrillation Detection Function
时间窗: 1-5 hours
Specificity refers to the ability of Masimo INVSENSOR00057 to correctly identify individuals who do not have atrial fibrillation. High specificity is important in minimizing false positives.
次要结局
未报告次要终点
研究者
研究点 (2)
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