NCT04041466已完成不适用
Validation of the Watch Withings HWA08 for the Detection of Atrial Fibrillation
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Withings
- 入组人数
- 140
- 试验地点
- 4
- 主要终点
- AF and SR classification accuracy
研究概览
简要总结
The proposed clinical study aims at validating the diagnostic performance, in comparison with a reference ECG, of Withings HWA08 watch for the automatic identification of atrial fibrillation (AF).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 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
- 否
入选标准
- •adults, men or women, at least 18 years old
- •person having signed the informed consent form
- •person affiliated to a social security system
排除标准
- •vulnerable subject according to current regulation:
- •pregnant woman, parturient or breastfeeding
- •subject deprived of freedom by judicial, medical or administrative decision
- •subject legally protected or unable to express his consent
- •subject non-beneficiary of healthcare
- •subject falling into more than one of the above categories
- •subject who refused to participate in the study
- •subject in linguistic or psychic incapacity to sign a written informed consent form
- •subject in physical incapacity to wear a watch on their wrist
- •subject with electrical stimulation by pacemaker
结局指标
主要结局
AF and SR classification accuracy
时间窗: 1 visit (30 minutes)
sensitivity and specificity of detection of AF and SR from 1-lead ECG against reference 12-lead ECG
次要结局
- Quality of the 1-lead ECG strips(1 visit (30 minutes))
- safety evaluation(1 visit (30 minutes))
研究者
研究点 (4)
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