Maestro Handheld Cardiac Monitor Validation
研究概览
详细说明
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.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Michigan
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Ann Arbor、Michigan、美国、48109
- University of Michigan Cardiovascular Center
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- ability to provide informed consent
Exclusion Criteria:
- implanted pacemakers
- open wounds or abrasions on their hands
- prior damage to hands or thumbs precluding obtaining an ECG tracing
学习计划
研究是如何设计的?
设计细节
- 主要用途:诊断
- 分配:非随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
其他:Patients in afib or flutter
Maestro ECG
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Telemetry is obtained through the Maestro handheld ECG device.
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其他:Patients in sinus rhythm
Maestro ECG
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Telemetry is obtained through the Maestro handheld ECG device.
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Sensitivity and Specificity of atrial fibrillation detection
大体时间:6 seconds
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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.
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6 seconds
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合作者和调查者
调查人员
- 首席研究员:Rakesh Latchamsetty, MD、University of Michigan
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
心律失常的临床试验
Maestro ECG的临床试验
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Medical University of Vienna尚未招聘
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Robert ShannonUniversity of California, Los Angeles; House Clinic, Inc.; Med-El Corporation未知