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

Not Applicable

Active, not recruiting

• Conditions: Atrial Fibrillation

• Registration Number: NCT05686330
• Lead Sponsor: Amsterdam University Medical Centers (UMC), Location Academic Medical Center (AMC)

Brief 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.

Study Timeline

• Study Start: 2022-11-16
• Study First Submitted: 2022-12-16
• Study First Submitted QC: 2023-01-13
• Study First Posted: 2023-01-17
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-16
• Primary Completion: 2025-07-17
• Study Completion: 2025-07-17
• Last Update Posted: 2025-07-20

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 436

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The incidence of atrial fibrillation	6 months	Detected with an Apple watch or with any other device such as a holter or on an ECG or telemetry

Secondary Outcome Measures

Name	Time	Method
The time until atrial fibrillation is first detected (days)	6 months	The number of days between the date of inclusion and the date AF is detected
The number of patients for whom medication for AF is initiated at the end of the study (anticoagulation and antiarrhythmic drugs)	6 months
The number of patients that undergo major cardiovascular events during the study period	6 months
Number of emergency department visits	6 months	Emergency department visits that take place during the study period, for any reason
The number of new arrhythmia diagnoses other than AF in each study arm	6 months	Detected by either the Apple watch, telemetry, holter or other devices used to detect arrhythmias

Trial Locations

Locations (2)

Cardiology Center of the Netherlands; 🇳🇱 Amsterdam, Noord-Holland, Netherlands

Spaarne Gasthuis; 🇳🇱 Haarlem, Noord-Holland, Netherlands