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

Last updated: September 10, 2025
Sponsor: Amsterdam University Medical Centers (UMC), Location Academic Medical Center (AMC)
Overall Status: Completed

Phase

N/A

Condition

Chest Pain

Circulation Disorders

Atrial Fibrillation

Treatment

Apple Watch

Clinical Study ID

NCT05686330
2021_209
  • Ages > 65
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

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

Total Participants: 436
Treatment Group(s): 1
Primary Treatment: Apple Watch
Phase:
Study Start date:
November 16, 2022
Estimated Completion Date:
July 17, 2025

Study 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.

Connect with a study center

  • Cardiology Center of the Netherlands

    Amsterdam, Noord-Holland
    Netherlands

    Site Not Available

  • Spaarne Gasthuis

    Haarlem, Noord-Holland 2035 RC
    Netherlands

    Site Not Available

  • Cardiology Center of the Netherlands

    Amsterdam 2759794, North Holland 2749879
    Netherlands

    Site Not Available

  • Spaarne Gasthuis

    Haarlem 2755003, North Holland 2749879 2035 RC
    Netherlands

    Site Not Available

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