NCT06892938

Brief Summary

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
232

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2024

Shorter than P25 for all trials

Geographic Reach
1 country

3 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 17, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 12, 2025

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

March 18, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 25, 2025

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2025

Completed
Last Updated

March 27, 2025

Status Verified

March 1, 2025

Enrollment Period

6 months

First QC Date

March 18, 2025

Last Update Submit

March 24, 2025

Conditions

Keywords

Atrial FibrillationWearable MonitorElectrocardiogramRing

Outcome Measures

Primary Outcomes (1)

  • Rhythm classification

    Automated rhythm characterization by the ring device as normal sinus rhythm, atrial fibrillation or other.

    Baseline

Study Arms (2)

Atrial Fibrillation history

Atrial fibrillation history or active atrial fibrillation

Diagnostic Test: Atrial Fibrillation Identification

Normal heart rhythm

Patients with no history of prior or active heart arrhythmia

Diagnostic Test: Atrial Fibrillation Identification

Interventions

Identification of atrial fibrillation by device.

Atrial Fibrillation historyNormal heart rhythm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with or without cardiac arrhythmic history who are 18 years or older and do not have an implanted cardiac device.

You may qualify if:

  • years of age or older

You may not qualify if:

  • Presence of pacemaker or defibrillator
  • Inability to wear a ring in size range available

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

XIMED

La Jolla, California, 92037, United States

Location

Our Lady of Lake Hospital

Baton Rouge, Louisiana, 70808, United States

Location

Allegheny General Hospital

Pittsburgh, Pennsylvania, 15232, United States

Location

MeSH Terms

Conditions

Atrial FibrillationArrhythmias, CardiacTachycardiaBradycardia

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsCardiac Conduction System Disease

Study Officials

  • Kenneth Civello, MD

    Our Lady of Lake Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 18, 2025

First Posted

March 25, 2025

Study Start

September 17, 2024

Primary Completion

March 12, 2025

Study Completion

April 1, 2025

Last Updated

March 27, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Single study

Locations