Étude Exploratoire Des Performances de Diagnostic Électrocardiographique de l'Apple Watch augmentée d'un Algorithme d'Intelligence Artificielle
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Performance of AF detection
研究概览
简要总结
This observational exploratory prospective study will evaluate the performance on an Artificial Intelligence (AI) solution interpreting ECG (electrocardiogram) collected from an Apple Watch (AI-AW) in the detection of Atrial Fibrillation (AF)
详细描述
After being informed about the study, participants hospitalized for ablation or cardioversion or having a cardiac rhythm consultation at the investigational center will have Apple Watch ECG recordings done simultaneously with 12-lead ECG measurements performed in accordance with the existing in-stay subject monitoring protocol. AI-AW will be compared to standard manual 12-lead ECG reviewed by cardiologists for AF detection.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient aged 22 or older, able and willing to participate in the study
- •Patient admitted to hospital for ablation, cardioversion or cardiac electrophysiological exploration or who come for regular rhythmology consultations
- •Patient who has read the information note and has given his or her consent before any procedure related to the study
- •Patient affiliated to social security
排除标准
- •Pregnant or breastfeeding women
- •Patient with a pacemaker, implantable defibrillator or cardiac resynchronisation therapy device.
- •Subject related to the investigator or any other staff member directly involved in the conduct of the study
- •Patient incapable of giving consent, minor or adult patient protected by law
结局指标
主要结局
Performance of AF detection
时间窗: 1 day
Performance of AF detection by an artificial intelligence (AI) solution interpreting ECG collected via Apple Watches (AI-AW), compared to physician's diagnosis from the 12 leads ECG
次要结局
- AW versus AI-AW(1 day)
- AI-AW versus AI-12lead(1 day)