NCT06071754已完成不适用
Validation of the Performance of the Electrocardiogram (ECG) Function in the Masimo INVSENSOR00057
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 365
- 试验地点
- 8
- 主要终点
- Validation of the Performance of the Electrocardiogram (ECG) Function in the Masimo INVSENSOR00057
研究概览
简要总结
The objective of this study is to validate the performance of the electrocardiogram (ECG) function of the Masimo INVSENSOR00057 against contemporaneous measurements
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
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject is 22 years of age or older
- •Subject is comfortable to read and communicate in English*
- •Subject belongs to one of two groups:
- •Subjects without any prior arrhythmia diagnosis presenting in normal sinus rhythm (Group1)
- •Subjects with history of paroxysmal or persistent atrial fibrillation presenting in atrial fibrillation (Group 2) *This is to ensure the subject can provide informed consent (as Masimo INVSENSOR00057 ECG study materials are currently available in English only) and can comply with study procedures.
排除标准
- •Subjects who are physically unable to wear a wristwatch
- •Subjects whose skin is not intact (e.g., has open wounds, has inflamed tattoos or piercings, has visible healing wounds) in or at the vicinity of the device placement site.
- •Subjects with an implantable defibrillator or cardiac pacing device.
- •Subjects with a skin condition which would preclude proper ECG electrode placement..
- •Subjects with known allergic reactions to adhesive tapes or ECG gel.
- •Subjects previously diagnosed with non-atrial fibrillation cardiac arrhythmia.
- •Subjects not suitable for the investigation at the discretion of the investigator or the clinical team
结局指标
主要结局
Validation of the Performance of the Electrocardiogram (ECG) Function in the Masimo INVSENSOR00057
时间窗: Approximately 30 minutes
Single Lead ECG, similar to lead I, intended to be used for Heart Rate measurement and AFib detection
次要结局
未报告次要终点
研究者
研究点 (8)
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