Realtime Diagnosis From Electrocardiogram Artificial Intelligence-Guided Screening for Atrial Fibrillation With Long Follow-Up (REGAL)
1 other identifier
interventional
2,000
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable atrial-fibrillation
Started Apr 2024
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 19, 2023
CompletedFirst Posted
Study publicly available on registry
June 28, 2023
CompletedStudy Start
First participant enrolled
April 10, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 1, 2026
January 22, 2026
January 1, 2026
2.4 years
June 19, 2023
January 20, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Atrial fibrillation
Number of participants diagnosed with atrial fibrillation
2 years
Secondary Outcomes (5)
Change in individuals' maximum learning span
Baseline, 2 years
Change in processing speed measure
Baseline, 2 years
Ischemic stroke or systemic embolism events
2 years
Major bleeding
2 years
Mortality
2 years
Study Arms (2)
Apple Watch Intervention Group
EXPERIMENTALParticipants 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.
Control Group
NO INTERVENTIONParticipants will receive usual care.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mayo Cliniclead
Study Sites (1)
Mayo Clinic
Rochester, Minnesota, 55905, United States
Related Publications (1)
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.
PMID: 37913853DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Xiaoxi Yao, PhD
Mayo Clinic
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
June 19, 2023
First Posted
June 28, 2023
Study Start
April 10, 2024
Primary Completion (Estimated)
September 1, 2026
Study Completion (Estimated)
September 1, 2026
Last Updated
January 22, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will not share