Confirmatory Clinical Investigation of Electrocardiographic Diagnostic Performance of the Apple Watch Augmented With an Artificial Intelligence Algorithm
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 220
- 试验地点
- 3
- 主要终点
- Evaluation of the performance of smartwatch ECG interpreted by Cardiologs Artificial Intelligence in detecting AF (Atrial Fibrillation or Flutter) as identified by the physician on the 12-lead ECG
研究概览
简要总结
The SWAF study will compare the performance of a smartwatch combined with Cardiologs Platform algorithm in the detection of Atrial Fibrillation and other arrhythmias with that measured on a manually read 12-lead ECG in subjects hospitalized for cardioversion or AF ablation.
详细描述
The SWAF study is a prospective, non-significant risk, non-randomized, multicentric, open, comparative, confirmatory study.
Under subject consent, subjects hospitalized for cardioversion or AF ablation will have a smartwatch ECG recording done simultaneously with 12-lead ECG measurement right before the intervention. If a subject is found in Normal Sinus Rhythm he/she will be discharged otherwise the patient will undergo cardioversion and will have simultaneous recordings done a second time after the intervention. All the measurements will be done in accordance with the existing subject monitoring protocol.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •Subjects over 18, able and willing to participate in the study
- •Subjects who are admitted to the hospital for a cardioversion or AF ablation procedure.
- •Subjects having read the patient information letter and provided his/her consent to participate in writing, by dating and signing the informed consent prior to any trial-related procedure being conducted
排除标准
- •Subjects with paced rhythm or implanted electronic devices
- •Pregnant or breast-feeding subjects
结局指标
主要结局
Evaluation of the performance of smartwatch ECG interpreted by Cardiologs Artificial Intelligence in detecting AF (Atrial Fibrillation or Flutter) as identified by the physician on the 12-lead ECG
时间窗: Readings taken simultaneously right before and right after the cardioversion according to the monitoring protocol at the hospital
Evaluation of the performance of smartwatch ECG interpreted by Cardiologs Artificial Intelligence in detecting AF (Atrial Fibrillation or Flutter) as identified by the physician on the 12-lead ECG in the independent annotation center, providing the ground truth from the 12-lead ECG
次要结局
- Evaluation of the performance of smartwatch ECG interpreted by Cardiologs Artificial Intelligence in detecting AF as identified by the physician on the smartwatch ECG(Readings taken simultaneously right before and right after the cardioversion according to the monitoring protocol at the hospital)
- Evaluation of the performance of smartwatch ECG interpreted by Cardiologs Artificial Intelligence in detecting Sinus Rhythm as identified by the physician on the smartwatch ECG(Readings taken simultaneously right before and right after the cardioversion according to the monitoring protocol at the hospital)
- Evaluation of the performance of smartwatch ECG interpreted by Cardiologs Artificial Intelligence in detecting Premature Supraventricular Complexes as identified by the physician on the smartwatch ECG(Readings taken simultaneously right before and right after the cardioversion according to the monitoring protocol at the hospital)
- Evaluation of the performance of smartwatch ECG interpreted by Cardiologs Artificial Intelligence in detecting Premature Ventricular Complexes as identified by the physician on the smartwatch ECG(Readings taken simultaneously right before and right after the cardioversion according to the monitoring protocol at the hospital)
- Evaluation of the performance of smartwatch ECG interpreted by Cardiologs Artificial Intelligence in detecting Tachycardia as identified by the physician on the smartwatch ECG(Readings taken simultaneously right before and right after the cardioversion according to the monitoring protocol at the hospital)
- Evaluation of the performance of smartwatch ECG interpreted by Cardiologs Artificial Intelligence in detecting Bradycardia as identified by the physician on the smartwatch ECG(Readings taken simultaneously right before and right after the cardioversion according to the monitoring protocol at the hospital)
- Assessment of the proportion of smartwatch ECGs identified as inconclusive by Cardiologs Artificial Intelligence and by the physician(Readings taken simultaneously right before and right after the cardioversion according to the monitoring protocol at the hospital)