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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

2000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-10

Study Completion Date

2026-09-30

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.

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Detailed Description

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Conditions

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Atrial Fibrillation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Apple Watch Intervention Group

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.

Group Type EXPERIMENTAL

Apple Watch

Intervention Type OTHER

Apple Watch

Control Group

Participants will receive usual care.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Apple Watch

Intervention Type OTHER

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No