Everbeat Ring ECG Clinical Concordance Study

• Conditions: Cardiovascular Diseases

• Registration Number: NCT05469542
• Lead Sponsor: Grektek Inc.

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-07
• Study First Submitted: 2022-07-04
• Study First Submitted QC: 2022-07-20
• Last Update Submitted: 2022-07-20
• Study First Posted: 2022-07-21
• Last Update Posted: 2022-07-21
• Study Start: 2022-08-01
• Primary Completion: 2022-09-20
• Study Completion: 2022-09-20

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 65

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
User acceptance survey	50 days	To assess the ease of use of the everbeat ring in a random selection of users.

Trial Locations

Locations (1)

BKLYNCardio; 🇺🇸 Brooklyn, New York, United States