NCT07223164已完成不适用
Validation of the Masimo Irregular Heartbeat Detection Algorithm in Participants Without Cardiovascular Disease
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- Specificity of Masimo SET®
研究概览
简要总结
Specificity measure of performance of the Irregular Heartbeat Detection algorithm (evaluated for the finger and wrist form factors) against the Masimo Radius VSM® reference ECG. Each form factor will be evaluated independently of one another
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
- •Subject is 18 to 80 years of age.
- •Comfortable to read and communicate in English.*
- •Subject passes the health assessment conducted by qualified study personnel, confirming they are in adequate health to participate in the required procedures
- •This is to ensure the participant can provide informed consent and can comply with study procedures (as study material are currently available in English only).
排除标准
- •Subject currently has a known cardiac disease condition.
- •Subject is pregnant or breastfeeding.
- •Subjects with a skin condition affecting the digits/chest, where the sensors are applied which would interfere with the path of lights (e.g., psoriasis, vitiligo, eczema, angioma, scar tissue, burn, fungal infection, substantial skin breakdown) or sensor adhesion.
- •Skin condition which would preclude proper ECG placement.
- •Subjects with nail polish or acrylic nails on the digits where sensor needs to be applied, who opt not to remove them.
- •Subject is allergic to any supplies used in the study (e.g., ECG gel, adhesives).
- •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.
研究组 & 干预措施
Specificity of Irregular Heartbeat Detection
Experimental
Specificity measure of performance of the Irregular Heartbeat Detection algorithm (evaluated for the finger and wrist form factors) against the Masimo Radius VSM® reference ECG. Each form factor will be evaluated independently of one another
干预措施: Masimo SET® and Masimo W1® (Device)
结局指标
主要结局
Specificity of Masimo SET®
时间窗: 1-2 hours
Specificity of Masimo W1®
时间窗: 1-2 hours
次要结局
未报告次要终点
研究者
研究点 (1)
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