Electrocardiogram Clinical Validation Study

Study Overview
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Brief Summary
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The purpose of the study is to confirm the Garmin ECG (electrocardiogram) software algorithm can detect and classify atrial fibrillation and normal sinus rhythm on single lead ECG data derived from a Garmin wrist-worn, consumer device. The study will also confirm the software's ability to create a Lead I ECG that is clinically equivalent to a reference device. The Garmin ECG software is not a diagnostic system and is intended for informational purposes only.

Official Title
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Electrocardiogram Clinical Validation Study

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Diagnostic Test: Electrocardiogram


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Able to read, understand, and provide written informed consent; Willing and able to participate in the study procedures as described in the consent form; Individuals who are 22 years of age and older; Able to communicate effectively with and follow instructions from the study staff; Have a wrist circumference that fits within the device band; and For subjects enrolled into the AF population, subjects must have a known diagnosis of AF and be in AF at the time of screening. Exclusion Criteria: Physical disability that precludes safe and adequate testing; Mental impairment resulting in limited ability to cooperate; Subjects with a pacemaker or implantable cardioverter-defibrillator (ICD); Acute myocardial infarction within 90 days of screening or other cardiovascular disease that, in the opinion of the Investigator, increases the risk to the subject or renders data uninterpretable; Acute pulmonary embolism, pulmonary infarction, or deep vein thrombosis within 90 days of screening; Stroke or transient ischemic attack within 90 days of screening; Subjects taking rhythm control drugs; Symptomatic (or active) allergic skin reactions such as eczema, rosacea, impetigo, dermatomyositis, or allergic contact dermatitis on both wrists or over electrode attachment sites, including known allergy or sensitivity to silicone bands primarily used in wrist-worn fitness devices; Known sensitivity to medical adhesives, isopropyl alcohol, watch bands, or ECG electrodes; A history of abnormal life-threatening rhythms as determined by the Investigator; Significant tremor that prevents subject from being able to hold still; Women who are pregnant at the time of study participation; and Subjects enrolled into the SR population must not have any diagnosis of AF.

Ages Eligible for Study
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Minimum Age: 22 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: Basic Science
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Atrial fibrillation (AF)<br>Patients with a known history of AF who are in AF at the time of study screening. | Diagnostic Test: Electrocardiogram<br>* Simultaneous assessment of the heart rhythm determined from a 12-lead ECG and the Garmin ECG software algorithm heart rhythm classification on single-lead ECG data derived from the wearable device. All participants will record three simultaneous 12-lead and single-lead ECGs.<br>|
| Other: Normal Sinus Rhythm (SR)<br>Patients with no known diagnosis of AF or other arrhythmia | Diagnostic Test: Electrocardiogram<br>* Simultaneous assessment of the heart rhythm determined from a 12-lead ECG and the Garmin ECG software algorithm heart rhythm classification on single-lead ECG data derived from the wearable device. All participants will record three simultaneous 12-lead and single-lead ECGs.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Specificity of rhythm classification | Number of participants with a SR software rhythm classification in agreement with a physician's interpretation of heart rhythm based on gold standard 12-lead ECG | 1 Day | 
| Sensitivity of rhythm classification | Number of participants with an AF software rhythm classification in agreement with a physician's interpretation of heart rhythm based on gold standard 12-lead ECG | 1 Day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of ECGs that pass a visual overlay | Number of participants with software's ability to produce a clinically equivalent waveform in agreement to a gold standard Lead I reference | Day 1 | 
| Difference in R-wave amplitudes between the software and gold standard reference | Number of participants with software's ability to produce a clinically equivalent waveform in agreement to a gold standard Lead I reference | Day 1 |