A Wearable With Photoplethysmography and 6-lead Electrocardiography for Atrial Fibrillation Detection
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 435
- 试验地点
- 1
- 主要终点
- Diagnostic accuracy of a wearable system for atrial fibrillation detection
研究概览
简要总结
A single center prospective case-control study to evaluate ability of a wearable to differentiate between atrial fibrillation (AF) and sinus rhythm (SR).
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
- 否
入选标准
- •Participants with current ECG-based diagnosis of atrial fibrillation, sinus rhythm or sinus rhythm with frequent (at least once in 2 minutes) premature atrial or ventricular contractions.
- •Age is between 18 - 99.
排除标准
- •Participants who refuse to sign an informed consent.
- •Participants with atrial fibrillation who are currently in a paced rhythm.
结局指标
主要结局
Diagnostic accuracy of a wearable system for atrial fibrillation detection
时间窗: PPG will be assessed in 2 minutes. ECG will be assessed in up to 10 months.
The wearable system comprises of two integrated components: a photoplethysmography (PPG) and a 6-lead ECG of the device. It works as described below. First, an automatic PPG algorithm will indicate whether atrial fibrillation is suspected. The rhythm assessment of PPG algorithm is based on pulse regularity. Next, a 6-lead ECG is acquired by the wearable. The rhythm assessment of ECG is based on P waves and regularity of QRS complexes. A diagnosis is made by independent cardiologists. The conclusion of a whole system comprising of both described methods will be compared with a gold standard multi-lead Holter ECG. This standard ECG is also evaluated by independent cardiologists.
次要结局
- Diagnostic accuracy of PPG algorithm of the wearable for atrial fibrillation detection(2 minutes.)
- Diagnostic accuracy of a 6-lead ECG of the wearable for atrial fibrillation detection(Up to 10 months.)