Comparison of 24-hour Holter Monitoring Versus 14-day Continuous ECG Patch Monitoring EZYPRO
试验速览
- 阶段
- 不适用
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Compare the detection difference of any type of arrhythmia between 14-day continuous ECG patch and 24-hour Holter monitor device among patients with suspected cardiac arrhythmia events over total wearing time
研究概览
简要总结
This is an open-label study to investigate the functional features of prolonged monitoring by 14-day EZYPRO® to improve the medical care and/or diagnosis for the patient with arrhythmia. Patients will be enrolled by outpatient basis from two clinical study sites. Enrolled patients will wear a traditional 24-hour Holter monitor and an 14-day EZYPRO® which can provide monitoring data for up to 14 days. This study will allow a direct comparison between two devices.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provision of signed written informed consent before enrollment into the study
- •Are able to communicate with the investigators
- •With suspected arrhythmia related signs and symptoms, judged by the investigators
- •Patients intend to wear ECG moniotrs
- •Males and females, 20 years of age or older
排除标准
- •Patients with skin allergies or injury, judged by investigators
- •Patients with specific arrhythmia or specific treatments, interfere with study evaluations, judged by investigators
- •Pregnant women
- •Currently participating in another trial or who participated in a previous clinical trial
研究组 & 干预措施
24-hour Holter and 14-day EZYPRO®
This is an open-label study to investigate the functional features of prolonged monitoring by 14-day EZYPRO® to improve the medical care and/or diagnosis for the patient with arrhythmia. One arm included.
干预措施: EZYPRO® (Device)
结局指标
主要结局
Compare the detection difference of any type of arrhythmia between 14-day continuous ECG patch and 24-hour Holter monitor device among patients with suspected cardiac arrhythmia events over total wearing time
时间窗: Up to14 days
The arrhythmia events of 14-day continuous ECG patch monitor (investigational device) and 24-hour Holter monitor will be analyzed by the qualified ECG technicians and determined by physician investigators at the study sites. Arrhythmia events are defined as detection of any 1 of 6 arrhythmias, including: * Supraventricular tachycardia (\>4 beats, not including atrial fibrillation or flutter) * Atrial fibrillation/flutter (\>4 beats) * Pause \>3 seconds * Atrioventricular block (Second-degree, 2:1 or third-degree atrioventricular block, need an advanced determination by the investigators) * Ventricular tachycardia (\>4 beats) * Polymorphic ventricular tachycardia/ventricular fibrillation In the end, all the detection will be confirmed by the investigators. McNemar's tests will be used to compare the matched pairs of proportion data.
次要结局
- The wearing time of 14-day continuous ECG patch (Study Compliance)(Up to14 days)