Everbeat Ring ECG Clinical Concordance Study

NCT ID: NCT05469542

Last Updated: 2022-07-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

65 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-08-01

Study Completion Date

2022-09-20

Brief Summary

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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

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Conditions

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Cardiovascular Diseases

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Grektek Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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BKLYNCardio

Brooklyn, New York, United States

Site Status

Countries

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United States

Facility Contacts

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Glenis Strachan, MD

Role: primary

718-237-4067

Other Identifiers

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Pro00064656

Identifier Type: -

Identifier Source: org_study_id

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