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

Not Applicable

• Conditions: Atrial Fibrillation
• Interventions: Other: Apple Watch

• Registration Number: NCT05923359
• Lead Sponsor: Mayo Clinic

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2023-06-19
• Study First Submitted QC: 2023-06-20
• Study First Posted: 2023-06-28
• Status Verified: 2024-04
• Study Start: 2024-04-10
• Last Update Submitted: 2024-04-25
• Last Update Posted: 2024-04-26
• Primary Completion: 2026-09
• Study Completion: 2026-09

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 2000

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

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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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Apple Watch Intervention Group	Apple Watch	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.

Primary Outcome Measures

Name	Time	Method
Atrial fibrillation	2 years	Number of participants diagnosed with atrial fibrillation

Secondary Outcome Measures

Name	Time	Method
Major bleeding	2 years	Number of major bleeding events
Ischemic stroke or systemic embolism events	2 years	Number of ischemic stroke or systemic embolism events
Change in individuals' maximum learning span	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.
Change in processing speed measure	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).
Mortality	2 years	Number of participant deaths

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States