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Maestro Handheld Cardiac Monitor Validation

NCT ID: NCT02977104

Last Updated: 2017-12-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-07-01

Study Completion Date

2017-12-05

Brief Summary

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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

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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

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Cardiac Arrhythmia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

40 subjects with Atrial Fibrillation 10 subjects with Atrial Flutter 20 subjects with Sinus Rhythm
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Patients in afib or flutter

Maestro ECG

Group Type OTHER

Maestro ECG

Intervention Type OTHER

Telemetry is obtained through the Maestro handheld ECG device.

Patients in sinus rhythm

Maestro ECG

Group Type OTHER

Maestro ECG

Intervention Type OTHER

Telemetry is obtained through the Maestro handheld ECG device.

Interventions

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Maestro ECG

Telemetry is obtained through the Maestro handheld ECG device.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Michigan

OTHER

Sponsor Role lead

Responsible Party

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Rakesh Latchamsetty

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rakesh Latchamsetty, MD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

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University of Michigan Cardiovascular Center

Ann Arbor, Michigan, United States

Site Status

Countries

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United States

Other Identifiers

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HUM00074138

Identifier Type: -

Identifier Source: org_study_id