Everbeat Ring ECG Clinical Concordance Study

Cardiovascular Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05469542
• Other study ID #: Pro00064656
• Status: Not yet recruiting
• Start date: August 1, 2022
• Est. completion date: September 20, 2022

Study information

• Verified date: July 2022
• Source: Grektek Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 65
• Est. completion date: September 20, 2022
• Est. primary completion date: September 20, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cardiovascular Diseases

Intervention

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.

Locations

Country	Name	City	State
United States	BKLYNCardio	Brooklyn	New York

Sponsors (1)

Lead Sponsor	Collaborator
Grektek Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	R-wave Amplitude	R Peak Amplitude intraclass correlation coefficient between test and reference devices in mm	50 days
Primary	ST-segment	Concordance in ST-segment deviation from the TP segment if present in mm	50 Days
Primary	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	User acceptance survey	To assess the ease of use of the everbeat ring in a random selection of users.	50 days