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Maestro Handheld Cardiac Monitor Validation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02977104
Recruitment Status : Completed
First Posted : November 30, 2016
Last Update Posted : December 8, 2017
Sponsor:
Information provided by (Responsible Party):
Rakesh Latchamsetty, University of Michigan

Study Description
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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.

Condition or disease Intervention/treatment Phase
Cardiac Arrhythmia Other: Maestro ECG Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 40 subjects with Atrial Fibrillation 10 subjects with Atrial Flutter 20 subjects with Sinus Rhythm
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Maestro Handheld Cardiac Monitor Validation
Actual Study Start Date : July 1, 2013
Actual Primary Completion Date : December 5, 2017
Actual Study Completion Date : December 5, 2017

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Patients in afib or flutter
Maestro ECG
 Other: Maestro ECG
Telemetry is obtained through the Maestro handheld ECG device.
Patients in sinus rhythm
Maestro ECG
 Other: Maestro ECG
Telemetry is obtained through the Maestro handheld ECG device.


Outcome Measures
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Primary Outcome Measures :
  1. Sensitivity and Specificity of atrial fibrillation detection [ Time Frame: 6 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02977104


Locations
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United States, Michigan
University of Michigan Cardiovascular Center
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
Investigators
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Principal Investigator: Rakesh Latchamsetty, MD University of Michigan
More Information
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Responsible Party: Rakesh Latchamsetty, Assistant Professor, University of Michigan
ClinicalTrials.gov Identifier: NCT02977104    
Other Study ID Numbers: HUM00074138
First Posted: November 30, 2016    Key Record Dates
Last Update Posted: December 8, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes