Everbeat Ring ECG Clinical Concordance Study

• Sponsor: Grektek Inc. (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05469542
• Collaborator: (none)
• Enrollment: 65
• Location: 1
• Anticipated Duration (Months): 1.6
• Patients Per Site Per Month: 39.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cardiovascular Diseases	Device: Everbeat Ring

Study Design

• Study Type: Observational
• Anticipated Enrollment: 65 participants
• Observational Model: Cohort
• Time Perspective: Cross-Sectional
• Official Title: Correlation of Electrocardiographic Signals Acquired by a Finger-worn ECG Sensor With a Standard 12-Lead ECG
• Anticipated Study Start Date: Aug 1, 2022
• Anticipated Primary Completion Date: Sep 20, 2022
• Anticipated Study Completion Date: Sep 20, 2022

Outcome Measures

Primary Outcome Measures

1. R-wave Amplitude [50 days]

   R Peak Amplitude intraclass correlation coefficient between test and reference devices in mm

2. ST-segment [50 Days]

   Concordance in ST-segment deviation from the TP segment if present in mm

3. 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

1. User acceptance survey [50 days]

   To assess the ease of use of the everbeat ring in a random selection of users.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	BKLYNCardio	Brooklyn	New York	United States	11217

Sponsors and Collaborators

• Grektek Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Grektek Inc.
• ClinicalTrials.gov Identifier: NCT05469542
• Other Study ID Numbers: Pro00064656
• First Posted: Jul 21, 2022
• Last Update Posted: Jul 21, 2022
• Last Verified: Jul 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Grektek Inc.: ECG; Wearables; Electrocardiography
• Additional relevant MeSH terms: Cardiovascular Diseases

Study Results

No Results Posted as of Jul 21, 2022