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Maestro Handheld Cardiac Monitor Validation

Primary Purpose

Cardiac Arrhythmia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Maestro ECG
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Cardiac Arrhythmia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • University of Michigan Cardiovascular Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Patients in afib or flutter

Patients in sinus rhythm

Arm Description

Maestro ECG

Maestro ECG

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
November 16, 2016
Last Updated
December 6, 2017
Sponsor
University of Michigan
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1. Study Identification

Unique Protocol Identification Number
NCT02977104
Brief Title
Maestro Handheld Cardiac Monitor Validation
Official Title
Maestro Handheld Cardiac Monitor Validation
Study Type
Interventional

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
July 1, 2013 (Actual)
Primary Completion Date
December 5, 2017 (Actual)
Study Completion Date
December 5, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Arrhythmia

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
40 subjects with Atrial Fibrillation 10 subjects with Atrial Flutter 20 subjects with Sinus Rhythm
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patients in afib or flutter
Arm Type
Other
Arm Description
Maestro ECG
Arm Title
Patients in sinus rhythm
Arm Type
Other
Arm Description
Maestro ECG
Intervention Type
Other
Intervention Name(s)
Maestro ECG
Intervention Description
Telemetry is obtained through the Maestro handheld ECG device.
Primary Outcome Measure Information:
Title
Sensitivity and Specificity of atrial fibrillation detection
Description
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.
Time Frame
6 seconds

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rakesh Latchamsetty, MD
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan Cardiovascular Center
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Maestro Handheld Cardiac Monitor Validation

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