Atrial Fibrillation
Conditions
Keywords
Atrial fibrillation, Cardiac arrhythmia, Smartwatch, Wearable technology, Digital health, Photoplethysmography, Electrocardiography, Remote monitoring, Screening, Randomized controlled trial, Outpatient care, Telemedicine
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.
Interventions
DEVICEApple Watch
Smartwatch for detecting atrial fibrillation using photoplethysmography (PPG)
Sponsors
Amsterdam University Medical Centers (UMC), Location Academic Medical Center (AMC)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Netherlands
Outcome results
None listed