Clinical Performance of Withings Move ECG Software for Atrial Fibrillation Detection
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Withings
- 入组人数
- 234
- 试验地点
- 3
- 主要终点
- Sensitivity and Specificity of the automatic classification in AF by Move ECG single-lead ECG against reference 12-lead ECG
研究概览
简要总结
Withings Move ECG watch is designed to record ECG and detect automatically atrial fibrillation. The aim of this study is to validate the performance of Move ECG watch to detect atrial fibrillation compared to a reference 12-lead ECG.
详细描述
Patients with atrial fibrillation are included in hospitals. On each patient, ECG with Move ECG and the reference 12-lead ECG are recorded simultaneously. Both records are then reviewed by independent cardiologists to assess
- The presence or absence of atrial fibrillation
- if waveforms of ECG recorded with Move ECG compared with the reference.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •male or female who are 18 years or older
- •Subject who signed the written informed consent form
排除标准
- •Vulnerable subject with regard to regulations
- •Pregnant, parturient or breastfeeding woman,
- •Subject who is deprived of liberty by judicial, medical or administrative decision,
- •Underage subject,
- •Legally protected subject, or subject who is unable to sign the written informed consent form,
- •Subject who is not beneficiary or not affiliated to a social security scheme,
- •Subject within several of the above categories,
- •Subject who refused to participate in the study,
- •Subject in physical incapacity to wear a wrist-worn watch
- •Subject with electrical stimulation by pacemaker
研究组 & 干预措施
atrial fibrillation (AF)
Patients diagnosed with AF during reference ECG
干预措施: ECG measurement (Diagnostic Test)
sinus rhythm (SR)
Patients diagnosed with SR during reference ECG
干预措施: ECG measurement (Diagnostic Test)
结局指标
主要结局
Sensitivity and Specificity of the automatic classification in AF by Move ECG single-lead ECG against reference 12-lead ECG
时间窗: 1 year
sensitivity from the 2x2 confusion matrix AF vs 'non-AF'
次要结局
- Comparability of ECG waveforms from single strip of Move ECG vs Lead-1 of reference 12-lead ECG(1 year)
- Safety of use of Move ECG(1 year)