Apple Watch for Atrial Fibrillation Detection

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Disqualifiers: Atrial fibrillation, Dementia, End-stage kidney disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 6 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 2 years

2000 Participants Needed

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Apple Watch for detecting atrial fibrillation?

Research shows that the Apple Watch can accurately detect atrial fibrillation (a type of irregular heartbeat) using its built-in electrocardiogram (ECG) feature. In a study, the Apple Watch was found to measure heart rate more accurately in patients with atrial fibrillation compared to those without it. ^{1 2 3 4 5}

Is the Apple Watch safe for detecting heart conditions?

The Apple Watch has been cleared by the FDA for detecting heart conditions like atrial fibrillation, and it has been used by millions of people without major safety concerns reported. ^{1 2 4 5 6}

How is the Apple Watch treatment for atrial fibrillation unique?

The Apple Watch is unique because it is the first wearable device with built-in electrodes to perform a single-lead electrocardiogram (ECG) to detect atrial fibrillation, allowing users to monitor their heart rhythm in real-time without needing traditional medical equipment. ^{1 4 5 6 7}

Research Team

Xiaoxi Yao, PhD

Principal Investigator

Mayo Clinic

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants in the experimental group wear an Apple Watch and use the Mayo Clinic ECG Study App for data collection

2 years

Continuous monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 years

Treatment Details

Interventions

• Apple Watch

Trial Overview 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.

Participant Groups

Group I: Apple Watch Intervention Group Experimental Treatment 1 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 Group Active Control 1 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:

• General wellness monitoring
• Heart rate monitoring
• Sleep tracking

Approved in European Union as Apple Watch for:

• General wellness monitoring
• Heart rate monitoring
• Sleep tracking
• ECG monitoring

Approved in Canada as Apple Watch for:

• General wellness monitoring
• Heart rate monitoring
• Sleep tracking

Approved in Japan as Apple Watch for:

• General wellness monitoring
• Heart rate monitoring
• Sleep tracking

Approved in China as Apple Watch for:

• General wellness monitoring
• Heart rate monitoring
• Sleep tracking

Approved in Switzerland as Apple Watch for:

• General wellness monitoring
• Heart rate monitoring
• Sleep tracking

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Findings from Research

A survey of 95 physicians revealed that nearly all (99.5%) opted for diagnostic testing in response to Apple Watch alerts for atrial fibrillation in asymptomatic patients, indicating a strong inclination towards further evaluation of these alerts.

There was significant variation in management approaches among different specialties, highlighting the need for standardized clinical guidelines for handling smartwatch AF notifications, as treatment decisions varied widely between primary care, emergency medicine, and cardiology physicians.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physician responses to apple watch-detected irregular rhythm alerts. Demkowicz, PC., Dhruva, SS., Spatz, ES., et al.[2023]

References

1. United States pubmed.ncbi.nlm.nih.gov

A comparison of manual electrocardiographic interval and waveform analysis in lead 1 of 12-lead ECG and Apple Watch ECG: A validation study. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

AVNRT captured by Apple Watch Series 4: Can the Apple watch be used as an event monitor? [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Accuracy of the Apple Watch 4 to Measure Heart Rate in Patients With Atrial Fibrillation. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

Physician responses to apple watch-detected irregular rhythm alerts. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Accuracy and clinical relevance of the single-lead Apple Watch electrocardiogram to identify atrial fibrillation. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Consumer-facing Diagnostic Sensors in a Patient with Implantable Cardioverter-Defibrillator. [2020]

7. United States pubmed.ncbi.nlm.nih.gov

Accuracy of the Apple watch for detection of AF: A multicenter experience. [2023]