Evaluation of the Consistency Between the Detection of Atrial Fibrillation by a Wearable Dynamic ECG Recorder and a Control Instrument
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 114
- 试验地点
- 1
- 主要终点
- Consistent rate of atrial fibrillation diagnosis
研究概览
简要总结
A Randomized, Crossover Trial is conducted to Evaluate Consistency Atrial fibrillation diagnosis between the Wearable Dynamic ECG Recorder and the Control device.
In this investigation, the following indicators is also evaluated:
- Sensitivity and specificity of the ECG App algorithm in detecting atrial fibrillation compared with physician-adjudicated Gold Standard ECG recorder.
- Waveform qualitative assessment
- Safety incident assessments. 114 subjects (60 healthy subjects in phase I and 54 subjects with atrial fibrillation diagnosis in phase II) are enrolled in the investigation according to the criteria.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •- All study participants must be able to provide written informed consent prior to study procedure. This study has 2 Phases.
- •Health conscious individuals
- •> 18 years of age
- •> 18 years of age
- •non critical patients ever diagnosed with atrial fibrillation
排除标准
- •• < 18 years old
- •Unable to consent
- •> 80 years of age
- •Previous history of cardiac disease (e.g., atrial fibrillation, myocardial infarction, congestive heart failure)
- •current status of non-sinus heart rhythm
- •Critical patients
结局指标
主要结局
Consistent rate of atrial fibrillation diagnosis
时间窗: second 60
Electrical signals from ECG electrodes are collected with tested device and gold standard device. An automatic diagnosis of atrial fibrillation made with the tested device, and diagnosis of atrial fibrillation is made by the investigators with gold standard device. Diagnosis results include: "with atrial fibrillation (AF)", "without atrial fibrillation (No AF)", or "indecipherable". After the diagnosis, the number of "with atrial fibrillation (AF)", "without atrial fibrillation (No AF)", or "indecipherable" cases measured by the two devices are calculated according to table 1, and then the results are evaluated for 3×3 matching consistency.
次要结局
- Sensitivity and specificity of the ECG App algorithm in detecting atrial fibrillation(second 60)
- waveform qualitative assessment 1(second 60)
- waveform qualitative assessment 2(second 60)
研究者
Ruogu.li
Chief Physician
Shanghai Chest Hospital