Everbeat Ring ECG Clinical Concordance Study

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Cardiovascular Diseases
• Intervention / Treatment: Device: Everbeat Ring

• Study Type: Observational
• Enrollment (Anticipated): 65

Contacts and Locations

Study Locations

• United States
  • New York
    • Brooklyn, New York, United States, 11217
      • BKLYNCardio
      • Contact: Glenis Strachan, MD; Phone Number: 718-237-4067; Email: gasb@gmail.com
      • Principal Investigator: Charles Pollack, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients aged 18-90 presenting for a routine internal medicine or cardiology clinic visit

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Cross-Sectional

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Grektek Inc.

Study record dates

Study Major Dates

• Study Start (Anticipated): August 1, 2022
• Primary Completion (Anticipated): September 20, 2022
• Study Completion (Anticipated): September 20, 2022

Study Registration Dates

• First Submitted: July 4, 2022
• First Submitted That Met QC Criteria: July 20, 2022
• First Posted (Actual): July 21, 2022

Study Record Updates

• Last Update Posted (Actual): July 21, 2022
• Last Update Submitted That Met QC Criteria: July 20, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: Electrocardiography; ECG; Wearables
• Additional Relevant MeSH Terms: Cardiovascular Diseases
• Other Study ID Numbers: Pro00064656

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No