Correlation of Electrocardiographic Signals Acquired by a Finger-worn ECG Sensor With a Standard 12-Lead ECG
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cardiovascular Diseases
- Sponsor
- Grektek Inc.
- Enrollment
- 65
- Locations
- 1
- Primary Endpoint
- R-wave Amplitude
- Last Updated
- 3 years ago
Overview
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.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
R-wave Amplitude
Time Frame: 50 days
R Peak Amplitude intraclass correlation coefficient between test and reference devices in mm
ST-segment
Time Frame: 50 Days
Concordance in ST-segment deviation from the TP segment if present in mm
Blinded Cardiologist Review
Time Frame: 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 Outcomes
- User acceptance survey(50 days)