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 software's ability to create a Lead-1 electrocardiogram (ECG) that is clinically equivalent to a reference device. Also, to confirm a rhythm classification algorithm and its ability to detect and classify heart rhythms into two categories (Sinus Rhythm or Atrial Fibrillation) using a single Lead ECG.

Official Title
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Electrocardiogram Clinical Validation Study

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Other: 1-Lead ECG
* Device: 12-Lead ECG


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Individuals who are 22 years of age and older Able to read, understand, and provide written informed consent Willing and able to participate in the study procedures as described in the consent Have a wrist circumference that fits within the band Able to communicate effectively with and follow instructions from the study staff 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 (MI) 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 Known sensitivity to medical adhesives, isopropyl alcohol, watch bands, or electrocardiogram (ECG) electrodes including known allergy or sensitivity to fluoroelastomer bands primarily used in wrist worn fitness devices A history of abnormal life-threatening rhythms as determined by the investigator Significant tremor that prevents subject from being able to hold still Pregnant women: Women who are pregnant at the time of study participation For subjects enrolled into the sinus rhythm population, they 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>Patient with a known history of AF who are in AF at the time of study screening. | Other: 1-Lead ECG<br>* All participants will record three single-lead ECGs<br>Device: 12-Lead ECG<br>* All participants will simultaneously record three 12-lead ECGs<br>|
| Other: Normal Sinus Rhythm (SR)<br>Patient with no known diagnosis of AF or other arrhythmia | Other: 1-Lead ECG<br>* All participants will record three single-lead ECGs<br>Device: 12-Lead ECG<br>* All participants will simultaneously record three 12-lead ECGs<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Software's Rhythm Classification of SR in Agreement to a Physician's Interpretation of a Gold Standard 12-lead ECG | Specificity of rhythm classification | 1 Day | 
| Number of Participants With Software's Rhythm Classification of AF in Agreement to a Physician's Interpretation of a Gold Standard 12-lead ECG | Sensitivity of rhythm classification | 1 Day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Software's Ability to Produce a Clinically Equivalent Waveform in Agreement to a Gold Standard Lead 1 Reference | Number of ECGs that pass a visual overlay | 1 Day | 
| Number of Participants With Software's Ability to Produce a Clinically Equivalent Waveform in Agreement to a Gold Standard Lead 1 Reference | Difference in R-wave amplitudes between the software and gold standard reference | 1 Day | 
| Ease of Use | Average ease of use on a 1 (Unable to Use) to 5 (Easiest to Use) scale | 1 Day |