A Real-World Validation Study of Intermittent Photoplethysmography Based Rhythm Monitoring for Atrial Fibrillation Detection
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Specificity
研究概览
简要总结
Mobile health solutions for rhythm monitoring (e.g. atrial fibrillation detection) using photoplethysmography (PPG) technology on a smartphone have been developed. This study validates the performance of a digital health application (FibriCheck®) using PPG technology on a smartphone against a single-lead ECG device (Kardia Mobile®).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is scheduled for an ablation procedure for AF, at least 4 weeks after the inclusion.
- •Subject provides informed consent.
- •Subject understands and agrees to comply with planned study procedures.
- •Subject is able to perform measurements of the heart rhythm using the FibriCheck application at home.
排除标准
- •Insufficient cognitive or comprehensive level of Dutch to participate to the trial.
- •No access to a smartphone or unable to perform FibriCheck measurements at home.
- •Pacemaker.
结局指标
主要结局
Specificity
时间窗: Two months
Proportion of true negative tests with FibriCheck® out of all patients in sinus rhythm on Kardia Mobile®.
Sensitivity
时间窗: Two months
Proportion of true positives tests with FibriCheck® out of all patients with AF on Kardia Mobile®.
Overall accuracy (proportion of correct classifications)
时间窗: Two months
Proportion of correct classifications with FibriCheck®. Correct classification is provided by Kardia Mobile®.
次要结局
- Accuracy by heart rate interval(Two months)
- Negative predictive value(Two months)
- Proportion of PPG measurements of insufficient quality for rhythm analysis(Two months)
- Proportion of ECG measurements of insufficient quality for rhythm analysis by heart rate interval(Two months)
- Sensitivity by heart rate interval(Two months)
- Specificity by heart rate interval(Two months)
- Positive predictive value(Two months)
- Proportion of ECG measurements of insufficient quality for rhythm analysis(Two months)
- Proportion of PPG measurements of insufficient quality for rhythm analysis by heart rate interval(Two months)