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

Study Overview
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Brief Summary
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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.

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

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Other: Apple Watch


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Apple Watch Intervention Group<br>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<br>* Apple Watch<br>|
| No Intervention: Control Group<br>Participants will receive usual care. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Atrial fibrillation | Number of participants diagnosed with atrial fibrillation | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline, 2 years | 
| 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). | Baseline, 2 years | 
| Ischemic stroke or systemic embolism events | Number of ischemic stroke or systemic embolism events | 2 years | 
| Major bleeding | Number of major bleeding events | 2 years | 
| Mortality | Number of participant deaths | 2 years |