Detection and Classification of Cardiac Rhythm and Atrial Fibrillation Using a Finger-worn Ring

NCT ID: NCT06892938

Last Updated: 2025-03-27

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

ACTIVE_NOT_RECRUITING

Total Enrollment

232 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-09-17

Study Completion Date

2025-04-01

Brief Summary

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Everbeat is a finger-worn ring that has a built-in electrocardiogram (ECG). In this study the investigators ensure that the ECG as read by the everbeat correctly classifies heart rhythms and detects atrial fibrillation. Investigators will also correlate the everbeat ECG waveform with a clinical-grade FDA approved electrocardiogram to ensure it may be reliably interpreted by clinicians or other algorithms.

Detailed Description

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In this study the participant will obtain a simultaneous electrocardiogram from both the everbeat ring system and a clinical-grade diagnostic ECG machine for correlation and analysis.

Conditions

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Atrial Fibrillation (AF) Arrhythmias Cardiac Tachycardia Palpitations Bradycardia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Atrial Fibrillation history

Atrial fibrillation history or active atrial fibrillation

Atrial Fibrillation Identification

Intervention Type DIAGNOSTIC_TEST

Identification of atrial fibrillation by device.

Normal heart rhythm

Patients with no history of prior or active heart arrhythmia

Atrial Fibrillation Identification

Intervention Type DIAGNOSTIC_TEST

Identification of atrial fibrillation by device.

Interventions

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Atrial Fibrillation Identification

Identification of atrial fibrillation by device.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* 18 years of age or older

Exclusion Criteria

* Presence of pacemaker or defibrillator
* Inability to wear a ring in size range available
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Everbeat

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kenneth Civello, MD

Role: PRINCIPAL_INVESTIGATOR

Our Lady of Lake Hospital

Locations

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XIMED

La Jolla, California, United States

Site Status

Our Lady of Lake Hospital

Baton Rouge, Louisiana, United States

Site Status

Allegheny General Hospital

Pittsburgh, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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EVB002

Identifier Type: -

Identifier Source: org_study_id

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