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Behavioural Intervention

Apple Watch for Atrial Fibrillation Detection

N/A
Waitlist Available
Led By Xiaoxi Yao, PhD
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Men with CHA2DS2-VASc2 ≥2 or women with CHA2DS2-VASc ≥ 3
Be older than 18 years old
Must not have
Diagnosed dementia
History of intracranial bleeding
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
No Placebo-Only Group

Summary

This trial will test if Apple Watch can detect early signs of atrial fibrillation, a form of irregular heart rhythm.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Since this trial involves using an Apple Watch for monitoring purposes rather than medication or invasive procedures, there may be minimal side effects related to wearing the device such as skin irritation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am at a higher risk for stroke due to my heart condition.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have been diagnosed with dementia.
Select...
I have had bleeding in my brain before.
Select...
My kidneys are in the final stage of failure.
Select...
I have been diagnosed with atrial fibrillation.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Atrial fibrillation
Secondary study objectives
Change in individuals' maximum learning span
Change in processing speed measure
Ischemic stroke or systemic embolism events
+2 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor
3,337 Previous Clinical Trials
3,059,174 Total Patients Enrolled
32 Trials studying Atrial Fibrillation
11,588 Patients Enrolled for Atrial Fibrillation
Xiaoxi Yao, PhDPrincipal InvestigatorMayo Clinic

Media Library

Apple Watch (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05923359 — N/A
~1333 spots leftby Sep 2026
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