NCT02875106已完成不适用
BAYathlon - a Digital Non-interventional AF Screening Study to Identify Commercial Pulse Detection Systems (CPDS) Detecting AF and Sinus Rhythm Parallel to ECG Recording Within Routine Clinical Setting
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 165
- 试验地点
- 1
- 主要终点
- The rate of correctly detected atrial fibrillation signals by CPDS in reference to ECG (sensitivity of CPDS).
研究概览
简要总结
The primary objective in this study is to identify commercial pulse detection systems (CPDS) parallel to electrocardiogram (ECG) recording within routine clinical setting, which are able to detect atrial fibrillation or sinus rhythm of screened patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Adult female and male patients for whom the decision to record an ECG was made as per investigator's routine treatment practice
- •Patient able and willing to provide signed informed consent
排除标准
- •Patients with any comorbidities or abnormalities of heart function or rhythm, which might, in the opinion of the investigator, interfere with the evaluation of study data
- •Patients participating in an investigational program with interventions outside of routine clinical practice
结局指标
主要结局
The rate of correctly detected atrial fibrillation signals by CPDS in reference to ECG (sensitivity of CPDS).
时间窗: 120 seconds
This will be calculated as proportion of patients with atrial fibrillation diagnosed by CPDS record out of the total number of patients diagnosed with atrial fibrillation by ECG record (for patients with diagnosis for both recordings available).
次要结局
- The rate of correctly detected atrial fibrillation signals by CPDS in reference to ECG (sensitivity of CPDS).(60 seconds, 180 seconds, 240 seconds, 300 seconds)
- The rate of correctly detected AF of the applied algorithm of the ECG-data in reference to the primary diagnosis of the investigator using the ECG-graph (sensitivity of algorithm).(120 seconds)
- The rate of correctly detected sinus rhythm signals by CPDS in reference to ECG (sensitivity of CPDS).(120 seconds)
研究者
研究点 (1)
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