NCT05686330

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

Enhanced Detection and Quickened Diagnosis of Atrial Fibrillation Using the Apple Watch: A Randomised Controlled Trial (EQUAL Study)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 436 (actual)
• Sponsor: Amsterdam University Medical Centers (UMC), Location Academic Medical Center (AMC) · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Atrial Fibrillation

Interventions

Type	Name	Description
DEVICE	Apple Watch	Smartwatch for detecting atrial fibrillation using photoplethysmography (PPG)

Timeline

• Start date: 2022-11-16
• Primary completion: 2025-07-17
• Completion: 2025-07-17
• First posted: 2023-01-17
• Last updated: 2025-09-16

Locations

2 sites across 1 country: Netherlands

Regulatory

• FDA-regulated device study