Maestro Handheld Cardiac Monitor Validation

University of Michigan

Status: Completed

Conditions: Cardiac Arrhythmia

Treatments: Other: Maestro ECG

Study type: Interventional

Funder types: Other

Identifiers

NCT02977104

HUM00074138

Details and patient eligibility

About

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.

Full 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.

Enrollment: 70 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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70 participants in 2 patient groups

Patients in afib or flutter

Other group

Description:

Maestro ECG

Treatment:

Other: Maestro ECG

Patients in sinus rhythm

Other group

Description:

Maestro ECG

Treatment:

Other: Maestro ECG