Maestro Handheld Cardiac Monitor Validation



Status:Completed
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:12/10/2017
Start Date:July 1, 2013
End Date:December 5, 2017

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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.

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.

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
We found this trial at
1
site
?
mi
from
Ann Arbor, MI
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