Apple Watch for Atrial Fibrillation Detection

Recruiting in Palo Alto (17 mi)

Overseen byXiaoxi Yao, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Mayo Clinic

No Placebo Group

Approved in 6 Jurisdictions

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

This trial is for individuals who've had a specific ECG at Mayo Clinic and are at high risk of undetected atrial fibrillation, based on an AI-ECG score. Men must have a CHA2DS2-VASc2 score of 2 or higher; women need a score of 3 or more. It's not for those already diagnosed with atrial fibrillation, dementia, end-stage kidney disease, history of brain bleeding, or those with certain heart devices.

Inclusion Criteria

You had a specific heart test called a 12-lead ECG at Mayo Clinic that lasted for 10 seconds.

You have a high score that suggests a high chance of having a heart condition called atrial fibrillation.

I am at a higher risk for stroke due to my heart condition.

Exclusion Criteria

I have been diagnosed with dementia.

Missing date of birth

I have had bleeding in my brain before.

+4 more

Participant Groups

The REGAL study is testing if the Apple Watch can be used as a long-term monitoring tool to spot early signs of atrial fibrillation—a heart condition that causes irregular heartbeat—by comparing it against traditional detection methods.

2Treatment groups

Experimental Treatment

Active Control

Group I: Apple Watch Intervention GroupExperimental Treatment1 Intervention

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 II: Control GroupActive Control1 Intervention

Participants will receive usual care.

Apple Watch is already approved in United States, European Union, Canada, Japan, China, Switzerland for the following indications:

🇺🇸 Approved in United States as Apple Watch for: