Maestro Handheld Cardiac Monitor Validation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Sensitivity and Specificity of atrial fibrillation detection
研究概览
简要总结
The purpose of this study is to demonstrate that the Maestro hand held heart monitor can accurately diagnose Atrial Fibrillation, atrial flutter or normal sinus rhythm in patients.
详细描述
The purpose of this study is to determine if Maestro can be used to detect heart arrhythmias, specifically atrial fibrillation in humans. Maestro will be used to measure heart rate and rhythm at the same time that patients are being monitored with a standard 3, 5, or 12 lead electrocardiogram (ECG) in a clinical setting. The recorded Maestro results will be compared to the ECG results to assess Maestro's accuracy.
Data will be analyzed by a pass/fail criterial. The data will be downloaded and printed for the investigators' interpretation who will first review and code the data from Meastro, blinded to the ECG findings. Then the investigators will interpret the ECG findings and the 2 sets of data will be compared. The ECG result is the true value with which to compare the Maestro result.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- 是
入选标准
- •ability to provide informed consent
排除标准
- •implanted pacemakers
- •open wounds or abrasions on their hands
- •prior damage to hands or thumbs precluding obtaining an ECG tracing
研究组 & 干预措施
Patients in afib or flutter
Maestro ECG
干预措施: Maestro ECG (Other)
Patients in sinus rhythm
Maestro ECG
干预措施: Maestro ECG (Other)
结局指标
主要结局
Sensitivity and Specificity of atrial fibrillation detection
时间窗: 6 seconds
Each sample acquired by the Maestro system will be automatically analyzed and rhythm categorized by the automated algorithm. This will then be assessed for accuracy and sensitivity and specificity for detection of atrial fibrillation will be calculated.
次要结局
未报告次要终点
研究者
Rakesh Latchamsetty
Assistant Professor
University of Michigan