SmartWATCHes for Detection of Atrial Fibrillation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 651
- 试验地点
- 2
- 主要终点
- Correct detection of AF
研究概览
简要总结
In this trial the Preventives Heartbeats algorithm will be tested in two wearable devices for its specificity and sensitivity to distinguish between AF and SR.
详细描述
Introduction
Particularly in stroke prevention, the detection of atrial fibrillation is of pivotal importance. Recent studies have impressively confirmed the merits of long-term monitoring. Nevertheless, and despite very mature technology, the currently available methods like long-term ECG with conductive adhesive electrodes or implantable loop recorders are burdened with disadvantages in that they are inconvenient, costly and/or invasive. A predecessor study gave us the possibility to test an app that employs photoplethysmographic signals on a smartphone camera-similar to pulse oximetry technology-to distinguish between atrial fibrillation and sinus rhythm. That retrospective study achieved a sensitivity and specificity of 95% (Krivoshei et al., Europace 2016). The prospective follow-up study DETECT AF pro is currently being conducted in cooperation with Prof. Dörr in Greifswald, Germany.
Our research group has been involved with testing the app's quality in clinical settings before implementing it for use. This procedure differs markedly from the otherwise common practice of marketing qualitatively inferior "health apps" without any clinical testing. There is no app equipped with comparable technology worldwide. The WATCH AF study is the first study on sophisticated rhythm analysis using a smartwatch worldwide.
Study design
Prospective, blinded, multicenter study.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 99 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects of legal age,
- •patients with either sinus rhythm (Group SR) or atrial fibrillation (Group AF)
- •signed informed consent form
排除标准
- •Legally incompetent persons
结局指标
主要结局
Correct detection of AF
时间窗: 5 minutes
Sensitivity and specificity of the Preventicus Heartbeats App to distinguish between AF and SR
次要结局
- Differences in correct detection of AF between Smartwatch and Wristband(5 minutes)
- Reduced sensitivity and specificity in patients with >2% premature beats(5 minutes)
