Realtime Diagnosis From Electrocardiogram Artificial Intelligence-Guided Screening for Atrial Fibrillation With Long Follow-Up (REGAL)

Last updated: April 30, 2025
Sponsor: Mayo Clinic
Overall Status: Active - Enrolling

Phase

N/A

Condition

Arrhythmia

Cardiac Disease

Atrial Fibrillation

Treatment

Apple Watch

Clinical Study ID

NCT05923359
22-011253
  • Ages > 18
  • All Genders

Study Summary

The purpose of this research is to test whether Apple Watch, used as a long-term monitoring device, can enable early detection of atrial fibrillation.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Had a 10-second 12-lead ECG done at Mayo Clinic

  • Have a high AI-ECG risk score indicating a high likelihood of previouslyunrecognized AF

  • Men with CHA2DS2-VASc2 ≥2 or women with CHA2DS2-VASc ≥ 3

Exclusion

Exclusion Criteria:

  • Diagnosed atrial fibrillation

  • Diagnosed dementia

  • Diagnosed end-stage kidney disease

  • History of intracranial bleeding

  • Have an implantable cardiac monitoring device, including a pacemaker, adefibrillator, or implanted loop recorder

  • Missing date of birth

  • Residence outside of the U.S. or missing address information

Study Design

Total Participants: 2000
Treatment Group(s): 1
Primary Treatment: Apple Watch
Phase:
Study Start date:
April 10, 2024
Estimated Completion Date:
September 30, 2026

Connect with a study center

  • Mayo Clinic

    Rochester, Minnesota 55905
    United States

    Site Not Available

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