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

Mayo Clinic

Status: Active, not recruiting

Conditions: Atrial Fibrillation

Treatments: Other: Apple Watch

Study type: Interventional

Funder types: Other

Identifiers

NCT05923359

22-011253

Details and patient eligibility

About

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.

Enrollment: 2,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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2,000 participants in 2 patient groups

Apple Watch Intervention Group

Experimental group

Description:

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.

Treatment:

Other: Apple Watch

Control Group

No Intervention group

Description:

Participants will receive usual care.