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OpenTrials
Active, Not Recruiting

NCT Number: NCT05923359

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

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, a defibrillator, or implanted loop recorder
  • Missing date of birth
  • Residence outside of the U.S. or missing address information

Treatment and study plan

Apple Watch

Other

Apple Watch

Primary outcomes

  1. Atrial fibrillation

    Time frame: 2 years

    Number of participants diagnosed with atrial fibrillation

Secondary outcomes

  1. Change in individuals' maximum learning span

    Time frame: Baseline, 2 years

    Measured using the Mayo Test Drive (MTD):Test Development through Rapid Iteration, Validation and Expansion. A web-based platform for remote self-administered cognitive assessment that uses the Stricker Learning Span (SLS), which is a computer adaptive word-list memory test that matches test difficulty to user performance. Maximum learning span is total number of words recognized.

  2. Change in processing speed measure

    Time frame: Baseline, 2 years

    Measured using the Mayo Test Drive (MTD):Test Development through Rapid Iteration, Validation and Expansion. A web-based platform for remote self-administered cognitive assessment that uses a symbols test to measure processing speed reported in average completion time (seconds).

  3. Ischemic stroke or systemic embolism events

    Time frame: 2 years

    Number of ischemic stroke or systemic embolism events

  4. Major bleeding

    Time frame: 2 years

    Number of major bleeding events

  5. Mortality

    Time frame: 2 years

    Number of participant deaths

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jun 28, 2023
Registry last updated
Jan 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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