Everbeat Ring ECG Clinical Concordance Study

Study Overview
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Brief Summary
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This study is a cross-sectional observational study conducted in patients referred for routine ECG, to compare output from the everbeat finger-worn ECG device to standard of care (SOC) 12-lead electrocardiography. No intervention is involved in this study. Patients visiting the study site during the study period will be assessed for eligibility on a convenience basis, and observational data will be recorded on those eligible.

Official Title
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Correlation of Electrocardiographic Signals Acquired by a Finger-worn ECG Sensor With a Standard 12-Lead ECG

Conditions
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Cardiovascular Diseases

Intervention / Treatment
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* Device: Everbeat Ring


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males or females aged 18 to 90 years. Under the care of a board-certified physician and referred for a routine electrocardiogram (ECG) Resting heart rate between 50 to 120 beats per minute (BPM). Exclusion Criteria: Inability to wear the everbeat ring. Prior history of movement disorders including Parkinson's or benign tremors. Prior history of allergic skin reactions to metal including stainless steel.

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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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Everbeat Ring|The primary objective of this study is to assess the concordance of specific ECG parameters obtained in the everbeat nine-lead ECG waveform with those obtained in the comparable leads from a standard 12-lead ECG recorder.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| R-wave Amplitude | R Peak Amplitude intraclass correlation coefficient between test and reference devices in mm | 50 days | 
| ST-segment | Concordance in ST-segment deviation from the TP segment if present in mm | 50 Days | 
| Blinded Cardiologist Review | Identify the first six consecutive distinct readable PQRST complexes without artifacts that match between the strips for evaluation. Each reviewer will assign a pass/fail to the strips by visually assessing all 6 PQRST complexes. A pass is given when the morphology of the PQRST complexes appears to overlay to the unaided eye. A measurement of the R amplitude from the isoelectric baseline to the nearest millimeter for the first two QRS complexes in both the reference strip and everbeat strip. The reviewers will be blinded to the identity of the reference strip and everbeat strip. | 50 Days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| User acceptance survey | To assess the ease of use of the everbeat ring in a random selection of users. | 50 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ECG, Wearables, Electrocardiography