NCT02977104

Maestro Handheld Cardiac Monitor Validation

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: University of Michigan · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Cardiac Arrhythmia

Interventions

Type	Name	Description
OTHER	Maestro ECG	Telemetry is obtained through the Maestro handheld ECG device.

Timeline

• Start date: 2013-07-01
• Primary completion: 2017-12-05
• Completion: 2017-12-05
• First posted: 2016-11-30
• Last updated: 2017-12-08

Locations

1 site across 1 country: United States