SmartWatch ECG Evaluation Trial I

Study Overview
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Brief Summary
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This is a single-center, non-randomized study to collect validation data for submission to the Food and Drug Administration (FDA) to support a 510(k) device clearance for a smartwatch ECG.

Detailed Description
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Obtain a simultaneous recording of a Lead I (RA-LA) ECG from the Smartwatch and a clinical standard device (GE Cardiosoft ECG). Subsequent recordings will be acquired from the other models of the Smartwatch as well as a recording utilizing the FDA-cleared KardiaMobile. Compare the ECG waveforms from the Smartwatch to the GE and KardiaMobile devices to demonstrate equivalence in terms of cross correlation (correlation coefficient >.95) and RMS Difference (<10 microvolts). Compare the algorithmic determination from the Smartwatch ECG to those of the GE and KardiaMobile to demonstrate equivalence.

Official Title
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SmartWatch ECG Evaluation Trial I

Conditions
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ECG Capability in Smartwatch

Intervention / Treatment
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* Diagnostic Test: We propose to validate these smartwatch ECG functions to support FDA submissions


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - 1. Male or female > 18 years of age. 2. Ability to understand and sign a written informed consent form, which must be obtained prior to initiation of any study procedures. 3. Being seen in the OU Cardiac Electrophysiology Outpatient Clinic. Exclusion Criteria: - 1. Inability or refusal of the patient and/or the patient's legally acceptable representative to provide written informed consent for any reason. 2. Other conditions that in the opinion of the Lead Investigator may increase risk to the subject and/or compromise the quality of the clinical trial.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Interventional Model Description: We propose to validate these smartwatch ECG functions to support FDA submissions
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Screen group<br>This is a single-center, non-randomized open study with a single-patient clinical trial design (i.e., the patients serve as their own control). | Diagnostic Test: We propose to validate these smartwatch ECG functions to support FDA submissions<br>* 1) Obtain a simultaneous recording of a Lead I (RA-LA) ECG from the Smartwatch and a clinical standard device (GE Cardiosoft ECG). Subsequent recordings will be acquired from the other models of the Smartwatch as well as a recording utilizing the FDA-cleared KardiaMobile.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| QRS amplitude | Recordings will be acquired from the other models of the Smartwatch as well as a recording utilizing the FDA-cleared KardiaMobile. | 30 seconds |