Validation of Software for Assessment of Atrial Fibrillation From Data Acquired by a Wearable Smartwatch
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Fitbit LLC
- 入组人数
- 472
- 试验地点
- 10
- 主要终点
- Evaluate the software algorithm's ability to classify a heart rhythm as sinus rhythm or atrial fibrillation from a waveform equivalent to a Lead I ECG.
研究概览
简要总结
The goal of this study is to validate the Fitbit ECG software algorithm's ability to detect atrial fibrillation using data derived from a Fitbit wrist-worn consumer device that features a single lead ECG. The performance of the software application will be measured against centralized Core Lab physician-adjudicated 12-lead ECG tracings from FDA cleared ECG monitors as reference standards. The Fitbit software is intended as a pre-screening technology. It should identify candidates who may benefit from further evaluation. The software is not intended to be a diagnostic system.
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
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Women and men 22 years of age or older
- •Capable of giving informed consent
- •Sufficient manual dexterity to capture an ECG from the Fitbit wrist-worn device.
- •Subjects in the atrial fibrillation (AF) cohort must have a known history of AF and must be in -AF at the time of enrollment based on the screening ECG
排除标准
- •Anti-arrhythmic (rhythm control) medication use (such as amiodarone or flecainide)
- •Cardiac pacemaker or implantable cardioverter-defibrillator
- •History of a life-threatening rhythm such as ventricular tachycardia or ventricular fibrillation
- •Subjects in the sinus rhythm (SR) cohort should not have any history of atrial fibrillation and should not be in atrial fibrillation or other atrial arrhythmia at the time of enrollment based on the screening ECG
结局指标
主要结局
Evaluate the software algorithm's ability to classify a heart rhythm as sinus rhythm or atrial fibrillation from a waveform equivalent to a Lead I ECG.
时间窗: Through study completion, an average of 4 months
Sensitivity and specificity of the software algorithm in classifying sinus rhythm and atrial fibrillation from the equivalent of a Lead I ECG waveform, compared with physician's interpretation of a standard 12-lead ECG. Performance goals are 90% (sensitivity) and 92% (specificity)
次要结局
- Confirm the software's ability to produce a waveform clinically equivalent to a Lead I ECG from a clinical reference device (12-lead ECG).(Through study completion, an average of 4 months)