NCT03769207已完成不适用
Evaluation of the Use of Apple Watch Features for Identification of Cardiac Arrhythmias
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Apple Inc.
- 入组人数
- 17
- 试验地点
- 2
- 主要终点
- Atrial Fibrillation or Atrial Flutter (AF) of at Least 30 Seconds Duration
研究概览
简要总结
This post-marketing study is conducted to characterize the ability of Apple Watch rhythm analysis software to identify Atrial Fibrillation (AF) and facilitate subsequent clinical evaluation among users who contact AppleCare.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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:
- •iPhone (5s or later) with iOS version 12.1.1 or later defined as iPhone model/iOS version used to complete screening eligibility.
- •Apple Watch (Series 1-4) with watchOS version 5.1.2 or later defined as Apple Watch model/watchOS paired with iPhone used to complete screening eligibility
- •At least one of the following by self-report before consent:
- •Irregular Rhythm Notification
- •ECG app classification of Atrial Fibrillation
- •ECG app classification of Inconclusive defined as "Inconclusive," "Heart Rate Over 120," or "Heart Rate Under 50"
- •Age ≥ 22 years at time of eligibility screening
- •Current resident of the United States at time of eligibility screening, and will reside in the United States for the length of the study
- •Proficient in written and spoken English
- •Valid phone number associated with iPhone, ascertained from self-report
- •Valid email address, ascertained from self-report
排除标准
- •Shared iCloud account
- •Shared AppleWatch
结局指标
主要结局
Atrial Fibrillation or Atrial Flutter (AF) of at Least 30 Seconds Duration
时间窗: During ambulatory ECG Monitoring (up to 8 days)
Detected on ambulatory ECG patch monitor for a participant who received an IRN or Apple Watch ECG app - AFib classification
次要结局
- Self-reported Contact With Healthcare Provider(Between 15 to 90 days following enrollment)
- Arrhythmias Other Than AF(During ambulatory ECG Monitoring (up to 8 days))
研究者
Marco Perez
Assistant Professor of Medicine (Cardiovascular Medicine)
Stanford University
研究点 (2)
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