Apple Heart Study: Assessment of Wristwatch-Based Photoplethysmography to Identify Cardiac Arrhythmias
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Apple Inc.
- 入组人数
- 419,927
- 试验地点
- 2
- 主要终点
- Confirmed AF With a Detection by a Component of the App
研究概览
简要总结
The Apple Heart Study (AHS) is a research study conducted to evaluate whether the Apple Heart Study App can use data collected on the Apple Watch to identify irregular heart rhythms, including those from potentially serious heart conditions such as atrial fibrillation. Up to 500,000 can participate in the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Possession of the following at time of eligibility screening, ascertained from automatic hardware/software/device pairing check:
- •iPhone (5s or later) with iOS version 11.0 or later defined as iPhone model/iOS version used to complete screening eligibility.
- •Apple Watch (Series 1 or later) with watchOS version 4.0 or later defined as Apple Watch model/watchOS paired with iPhone used to complete screening eligibility.
- •Current resident of the United States at time of eligibility screening, defined by self-reported state of residence within the 50 states of the United States or District of Columbia.
- •Proficient in written and spoken English, defined by self-report of comfort reading, writing, and speaking English on iPhone.
- •Valid phone number associated with iPhone, ascertained from self-report.
- •Valid email address, ascertained from self-report.
排除标准
- •Self-reported diagnosis of Atrial Fibrillation.
- •Self-reported diagnosis of Atrial Flutter.
- •Currently on anti-coagulation therapy.
结局指标
主要结局
Confirmed AF With a Detection by a Component of the App
时间窗: During ambulatory ECG monitoring (up to 8 days)
Simultaneous ambulatory ECG monitoring indicating an irregular rhythm consistent with AF during time intervals when an app component (tachogram) is positive for an irregular pulse among those who received an irregular heartbeat notification.
Atrial Fibrillation (AF) of Greater Than 30 Seconds
时间窗: During ambulatory ECG monitoring (up to 8 days)
Proportion of notified participants who received an irregular pulse notification and that had AF detected on the ambulatory ECG.
次要结局
- Concordant AF With App Algorithm Notification(During ambulatory ECG monitoring (up to 8 days))
- Self-reported Contact With a Health Care Provider(90 days to 15 months)
研究者
Minang (Mintu) Turakhia
Associate Professor of Medicine, Stanford University
Stanford University