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Atrial FibrillationNCT05923359

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

A study testing Apple Watch in people with Atrial Fibrillation, run by Mayo Clinic at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Atrial Fibrillation
What is being tested?
Apple Watch
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,000 participants
Where
1 siteUnited States
Study dates
10 Apr 2024to Mar 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Mayo Clinic

    Rochester, Minnesota, 55905

Other trials in United States

About this study

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.

Being tested
Apple Watch
Medical subject headings
Atrial Fibrillation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Apple WatchOther

    Apple Watch

Study groups in NCT05923359
Study groupRoleWhat they receive
Apple Watch Intervention GroupExperimentalParticipants 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.
Receives: Other: Apple Watch
Control GroupNo interventionParticipants will receive usual care.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Atrial fibrillation

    Number of participants diagnosed with atrial fibrillation

    Measured: 2 years

Secondary outcomes (5)

  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.

    Measured: 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).

    Measured: Baseline, 2 years

  3. Ischemic stroke or systemic embolism events

    Number of ischemic stroke or systemic embolism events

    Measured: 2 years

  4. Major bleeding

    Number of major bleeding events

    Measured: 2 years

  5. Mortality

    Number of participant deaths

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jun 2023
  2. Study start10 Apr 2024
  3. Primary completionMar 2028 (estimated)
  4. Study completionMar 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
2,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05923359
Sponsor's protocol ID
22-011253
Status last verified
Oct 2026
First submitted
19 Jun 2023
Last updated
13 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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

Questions about this trial

What is this clinical trial studying?

A study testing Apple Watch in people with Atrial Fibrillation, run by Mayo Clinic at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Atrial fibrillation (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05923359, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.

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