Maestro Handheld Cardiac Monitor Validation

Cardiac Arrhythmia Clinical Trial

Official title:

Maestro Handheld Cardiac Monitor Validation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02977104
• Other study ID #: HUM00074138
• Status: Completed
• Phase: N/A
• First received: November 16, 2016
• Last updated: December 6, 2017
• Start date: July 1, 2013
• Est. completion date: December 5, 2017

Study information

• Verified date: December 2017
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: December 5, 2017
• Est. primary completion date: December 5, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arrhythmias, Cardiac
• Cardiac Arrhythmia

Intervention

Other:
• Maestro ECG
Telemetry is obtained through the Maestro handheld ECG device.

Locations

Country	Name	City	State
United States	University of Michigan Cardiovascular Center	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity and Specificity of atrial fibrillation detection	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.	6 seconds