MedPath

Maestro Handheld Cardiac Monitor Validation

Not Applicable
Completed
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
Inclusion Criteria
  • ability to provide informed consent
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Exclusion Criteria
  • implanted pacemakers
  • open wounds or abrasions on their hands
  • prior damage to hands or thumbs precluding obtaining an ECG tracing
Read More

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Patients in afib or flutterMaestro ECGMaestro ECG
Patients in sinus rhythmMaestro ECGMaestro ECG
Primary Outcome Measures
NameTimeMethod
Sensitivity and Specificity of atrial fibrillation detection6 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
NameTimeMethod

Trial Locations

Locations (1)

University of Michigan Cardiovascular Center

🇺🇸

Ann Arbor, Michigan, United States

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