Detection and Classification of Cardiac Rhythm and Atrial Fibrillation Using a Finger-worn Ring (FINDER-AF)

Finger Worn Detection Via Electrocardiographic Ring of Atrial Fibrillation and ECG Waveform Analysis (FINDER-AF)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Bradycardia; Tachycardia; Atrial Fibrillation (AF); Palpitations; Arrhythmias Cardiac
• Intervention / Treatment: Diagnostic test: Atrial Fibrillation Identification

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 232

Contacts and Locations

Study Locations

• United States
  • California
    • La Jolla, California, United States, 92037
      • XIMED
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70808
      • Our Lady of Lake Hospital
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15232
      • Allegheny General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-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.

Description

Inclusion Criteria:

• 18 years of age or older

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Atrial Fibrillation history; Atrial fibrillation history or active atrial fibrillation	Diagnostic test: Atrial Fibrillation Identification; Identification of atrial fibrillation by device.
Normal heart rhythm; Patients with no history of prior or active heart arrhythmia	Diagnostic test: Atrial Fibrillation Identification; Identification of atrial fibrillation by device.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rhythm classification	Automated rhythm characterization by the ring device as normal sinus rhythm, atrial fibrillation or other.	Baseline

Collaborators and Investigators

• Sponsor: Everbeat
• Investigators: Principal Investigator: Kenneth Civello, MD, Our Lady of Lake Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 17, 2024
• Primary Completion (Actual): March 12, 2025
• Study Completion (Estimated): April 1, 2025

Study Registration Dates

• First Submitted: March 18, 2025
• First Submitted That Met QC Criteria: March 18, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 27, 2025
• Last Update Submitted That Met QC Criteria: March 24, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Atrial Fibrillation; Electrocardiogram; Ring; Wearable Monitor
• Additional Relevant MeSH Terms: Cardiac Conduction System Disease; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Atrial Fibrillation; Tachycardia; Bradycardia
• Other Study ID Numbers: EVB002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Single study

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No