Detection and Quantification of Atrial Fibrillation in High-risk Patients Using a Smartwatch Wearable (Apple Watch) (EQUAL)

Amsterdam University Medical Centers (UMC), Location Academic Medical Center (AMC)

Status: Active, not recruiting

Conditions: Atrial Fibrillation

Treatments: Device: Apple Watch

Study type: Interventional

Funder types: Other

Identifiers

NCT05686330

2021_209

Details and patient eligibility

About

This is a randomized controlled trial evaluating atrial fibrillation (AF) detection through smartwatch-based screening in high-risk patients using an Apple Watch with integrated PPG and ECG functions.

Full description

This is a multicenter randomized controlled trial evaluating whether six months of heart rate and rhythm monitoring with a smartwatch (Apple Watch Series 5 or 8) equipped with photoplethysmography (PPG) and ECG functions increases atrial fibrillation (AF) detection in high-risk cardiac patients (age ≥65, CHA₂DS₂-VASc ≥2 for men, ≥3 for women) without previously known AF.

Patients are randomized to either smartwatch-based monitoring or standard care. Participants in the intervention group receive an Apple Watch paired with a smartphone app and are instructed to wear the device for at least 12 hours per day. Continuous rhythm monitoring is performed using PPG, with ECGs recorded upon symptom onset or irregular rhythm detection. ECG data are transmitted via the app to a secure platform and reviewed within 24 hours by an independent eHealth team supervised by a cardiologist. Patients and their treating physicians are notified upon new AF diagnoses.

To evaluate the primary endpoint, a total of 218 patients per arm were required according to the sample size calculation.

Enrollment: 436 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age ≥ 65 years
• Chadsvasc score ≥2 for men and ≥ for women at the time of eligibility screening
• Written informed consent as documented by signature from the participant
• Possession of iPhone (6S or later)

Exclusion criteria

• Diagnosis of atrial fibrillation or atrial flutter
• Currently on anticoagulation therapy
• Cardiac implanted electronic device (pacemaker, ICD)
• Smartwatch cannot be worn due to comprehensible reasons (allergic reactions, wounds, amputations, other)
• Significant mental or cognitive impairment

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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436 participants in 2 patient groups

Interventional group (Apple watch)

Experimental group

Description:

These participants will wear a smartwatch (Apple Watch) for 6 months during 12 hours a day. The smartwatch will alarm the participant if an irregular heart rhythm is detected. When a participant experiences any symptoms or receives an irregular heartbeat notification, they can record an ECG with the smartwatch. The ECG will automatically be sent to the Telecure team for evaluation.

Treatment:

Device: Apple Watch

Control group

No Intervention group

Description:

Patients in the control group received standard care, which could include conventional rhythm monitoring methods such as Holter monitoring, in-hospital telemetry, or the use of handheld mobile ECG devices, at the discretion of the treating cardiologist. At the end of the study period the investigator will either call the participant to check for these outcome measures.