Accuracy of the Apple Watch Series 4 for Detection of Heart Rhythm: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Heart rate accuracy compared to telemetry
研究概览
简要总结
The objective of this study is to assess the accuracy of the Apple Watch 4 Series watch in generating an ECG that is suitable for determination of heart rhythm compared to rhythms monitored via telemetry. Secondary objective is to assess the accuracy of the Apple Watch 4 series watch in identifying atrial fibrillation when it is present.
详细描述
The study will assess the accuracy of the Apple watch 4 series watch when worn by post-operative cardiac surgery patients after they have transferred from the ICU to the cardiac telemetry unit.
During testing each subject will wear:
- An Apple Watch 4 series watch for no more than 5 minutes.
- Standard continuous telemetry monitor
The location of the watch (left or right wrist) will be randomly assigned.
Heart rate and rhythm will be assessed by obtaining tracings from the Apple Watch 4 series watch while at the same point in time obtaining tracings from a standard telemetry monitor.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Factorial
- 主要目的
- Other
- 盲法
- None
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
- •Age > 18 years
- •Post-operative cardiac surgery patients on the cardiac telemetry floors at the Cleveland Clinic Main Campus
排除标准
- •Presence of a cardiac pacemaker
- •Use of a radial artery graft for coronary artery bypass grafting
- •Tattoos located on the skin of the wrist or forearm where the Apple Watch 4 will be placed
研究组 & 干预措施
Apple Watch 4 Series Device
Apple watch 4 series heart rate monitoring device
干预措施: Apple Watch 4 Series Device (Device)
Continuous Telemetry
Standard continuous telemetry monitoring device
干预措施: Continuous Telemetry Monitor (Device)
结局指标
主要结局
Heart rate accuracy compared to telemetry
时间窗: 5 minutes
Apple Watch 4 Series heart rate monitor device accuracy compared to standard continuous telemetry monitor. This will be expressed by the correlation coefficient.
次要结局
- Heart rhythm accuracy compared to telemetry(5 minutes)
研究者
Marc Gillinov, MD
Principal Investigator
The Cleveland Clinic