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Active, not recruitingNCT05923359Updated Jan 22, 2026

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

An interventional study of Apple Watch in Atrial Fibrillation, sponsored by Mayo Clinic. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-22.

Sponsored by Mayo Clinic · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
2,000
Allocation
Randomized
Ages
18 Years and older
Sex
All
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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.

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Conditions studied

  • Atrial Fibrillation

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In context

Atrial Fibrillation

3,870 studies on the registry are indexed under Atrial Fibrillation; 924 are open to participants now.

This study's planned enrollment of 2,000 is above the median of 144 across 2,380 interventional studies indexed under Atrial Fibrillation.

Browse Atrial Fibrillation studies →

Lead sponsor

Mayo Clinic is the lead sponsor of 3,218 studies on the registry; 670 are open to participants now.

Of its 445 completed or terminated interventional studies of FDA-regulated products, 313 (70%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
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Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
2,000 participants (estimated)

Study arms

  • Experimental
    Apple Watch Intervention Group

    Participants will be asked to wear an Apple Watch and use the Mayo Clinic ECG Study App to collect and share data with the study team.

    Other: Apple Watch

  • No intervention
    Control Group

    Participants will receive usual care.

Interventions

  • OtherApple Watch

    Apple Watch

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What researchers measure

Primary outcomes

  1. Atrial fibrillation

    Number of participants diagnosed with atrial fibrillation

    Time frame: 2 years

Secondary outcomes

  1. Change in individuals' maximum learning span

    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.

    Time frame: Baseline, 2 years

  2. Change in processing speed measure

    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).

    Time frame: Baseline, 2 years

  3. Ischemic stroke or systemic embolism events

    Number of ischemic stroke or systemic embolism events

    Time frame: 2 years

  4. Major bleeding

    Number of major bleeding events

    Time frame: 2 years

  5. Mortality

    Number of participant deaths

    Time frame: 2 years

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Study locations

1 site
  • Mayo Clinic
    Rochester, Minnesota 55905, United States
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References and documents

Publications

  • Yao X, Attia ZI, Behnken EM, Hart MS, Inselman SA, Weber KC, Li F, Stricker NH, Stricker JL, Friedman PA, Noseworthy PA. Realtime Diagnosis from Electrocardiogram Artificial Intelligence-Guided Screening for Atrial Fibrillation with Long Follow-Up (REGAL): Rationale and design of a pragmatic, decentralized, randomized controlled trial. Am Heart J. 2024 Jan;267:62-69. doi: 10.1016/j.ahj.2023.10.005. Epub 2023 Oct 30. PubMed 37913853 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 22, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05923359
Lead sponsor
Mayo Clinic
Responsible party
Xiaoxi Yao (Principal Investigator, Mayo Clinic) — Principal investigator
First posted
Jun 28, 2023
Start date
Apr 10, 2024
Primary completion
Sep 2026 (estimated)
Completion
Sep 2026 (estimated)
Last update
Jan 22, 2026

Study contacts

Xiaoxi Yao, PhD
principal investigator · Mayo Clinic

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.

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