Cardiovascular Diseases
Conditions
Keywords
ECG, Wearables, Electrocardiography
Brief summary
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.
Interventions
DEVICEEverbeat 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.
Sponsors
Grektek Inc.
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| R-wave Amplitude | 50 days | R Peak Amplitude intraclass correlation coefficient between test and reference devices in mm |
| ST-segment | 50 Days | Concordance in ST-segment deviation from the TP segment if present in mm |
| Blinded Cardiologist Review | 50 Days | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| User acceptance survey | 50 days | To assess the ease of use of the everbeat ring in a random selection of users. |
Countries
United States
Outcome results
None listed