Investigation Clinique Observationnelle Des Performances de Diagnostic Electrocardiographique de l'Apple Watch (App ECG Version 2.0) 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 prospective clinical investigation 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
Each patient hospitalized for ablation or cardioversion and having given consent to participate in the clinical investigation will have ECG recordings by Apple Watch performed simultaneously with a 12D ECG measurement by a cardiologist before and/or after treatment, in accordance with the existing patient monitoring protocol. Similarly, patients attending a rhythmology consultation or hospitalized in the cardiology department will have simultaneous ECG recordings with an Apple Watch during the scheduled routine 12D ECG recording.
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 comes for regular rhythmology consultations or hospitalized in cardiology department
- •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)