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

Not Applicable

• Conditions: Atrial Fibrillation

• 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

Study Timeline

• Study First Submitted: 2023-06-19
• Study First Submitted QC: 2023-06-20
• Study First Posted: 2023-06-28
• Study Start: 2024-04-10
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-30
• Last Update Posted: 2025-05-02
• 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

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Ischemic stroke or systemic embolism events	2 years	Number of ischemic stroke or systemic embolism events
Major bleeding	2 years	Number of major bleeding 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