NCT05668377招募中不适用
Automated Diagnostic Performance of Smartwatch ECG for Arrhythmia Detection Using the PulseAI Neural Network.
PulseAI Ltd1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2023年1月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Evaluate the performance of arrhythmia detection.
研究概览
简要总结
The study is to evaluate the performance of the PulseAI neural network technology at interpreting ECG data recorded using a single-lead Smartwatch (Apple Watch).
详细描述
Under subject consent, subjects will have a 12-lead ECG immediately followed by a smartwatch ECG. The heart rhythm and ECG interval measurements will be compared between the 12-lead ECG and smartwatch ECG.
The arrhythmias will include:
- Atrial Fibrillation/Flutter
- Tachycardia
- Bradycardia
- Premature Atrial Contractions
- Premature Ventricular Contractions
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
- 22 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
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.
- •Patient who has read the information note and has given their consent before any procedure related to the study.
排除标准
- •Patient with a pacemaker, implantable defibrillator or cardiac resynchronisation therapy device.
结局指标
主要结局
Evaluate the performance of arrhythmia detection.
时间窗: 12 months
Evaluate the performance of arrhythmia detection by the PulseAI neural network applied to ECG data collected via the Smartwatch compared to physicians' interpretation of the 12-lead ECG.
次要结局
- Evaluate the performance of the Apple Watch ECG interpretation Software compared to the PulseAI software(12 months)
- Evalaute the performance of QTc interval measurement(12 months)
研究者
研究点 (1)
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