Maestro Handheld Cardiac Monitor Validation
- Conditions
- Cardiac Arrhythmia
- Interventions
- Other: Maestro ECG
- Registration Number
- NCT02977104
- Lead Sponsor
- University of Michigan
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 70
- ability to provide informed consent
- implanted pacemakers
- open wounds or abrasions on their hands
- prior damage to hands or thumbs precluding obtaining an ECG tracing
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Patients in afib or flutter Maestro ECG Maestro ECG Patients in sinus rhythm Maestro ECG Maestro ECG
- Primary Outcome Measures
Name Time Method Sensitivity and Specificity of atrial fibrillation detection 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University of Michigan Cardiovascular Center
🇺🇸Ann Arbor, Michigan, United States