Leveraging Wearable Technologies for Arrhythmia Detection in Children - The PAW (Pediatric Apple Watch) Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 107
- 试验地点
- 2
- 主要终点
- Heart rate correlation
研究概览
简要总结
Specific Aim #1 - To determine the accuracy of Apple Watch ECG tracings heart rate in children.
Specific Aim #2 - To determine if extended monitoring with the Apple Watch can identify arrhythmia events that were not detected by short term clinical monitoring.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All pediatric patients age 6 - 21 years undergoing clinically indicated arrhythmia monitoring
- •Patients with developmental ability (as determined by patient and parents) to safely wear the Apple Watch and utilize the patient activated trigger buttons on both the clinical monitor and the Apple Watch.
排除标准
- •Age < 6 years. Those under 6 many not be able to safely use the watch and have the developmental ability (as gauged by clinician and parents) to utilize the trigger features on the watch and cardiac rhythm monitor.
- •Inability to effectively utilize the triggered features of the monitor or watch
- •Patients unable to utilize the Apple Watch.
研究组 & 干预措施
Apple Watch
Participants will wear an Apple Watch for 6 months
干预措施: Apple Watch (Device)
结局指标
主要结局
Heart rate correlation
时间窗: Up to 2 weeks
Comparison of heart rate (bpm) between the Apple Watch and standard clinical rhythm monitor
Arrhythmia correlation
时间窗: Up to 6 months
Comparison of the number of clinically significant arrhythmia events between the Apple Watch and standard clinical rhythm monitor. Clinically significant arrhythmia events include supraventricular arrhythmias, ventricular arrhythmias, sinus pauses, and conduction abnormalities/heart block
次要结局
未报告次要终点
研究者
Scott Ceresnak
Professor of Pediatrics
Stanford University