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NCT04809922

Accuracy of Cardiac Wearables Devices to Detect Atrial Fibrillation

Completed Last updated 1 March 2024
What this trial tests

trial testing cardiac wearable devices in Atrial Fibrillation (AF) in 312 participants. Completed in 28 February 2024.

Timeline
6 April 2021
Primary endpoint
31 January 2024
28 February 2024

Quick facts

Lead sponsorUniversity Hospital, Basel, Switzerland
StatusCompleted
Study typeOBSERVATIONAL
Enrollment312
Start date6 April 2021
Primary completion31 January 2024
Estimated completion28 February 2024
Sites1 location across Switzerland

Drugs / interventions tested

Conditions studied

Sponsor

University Hospital, Basel, Switzerland

Who can join

18 and older, any sex, with Atrial Fibrillation (AF). Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Atrial fibrillation (AF) is the most common cardiac arrhythmia. This study is to assess the heart rhythm device accuracy of five cardiac wearable devices (Apple Watch, Kardia Mobile/Kardia Mobile 6L, Fitbit Sense, Samsung Galaxy Watch 3 and Withings Scanwatch, Withings SA, Model Number: HWA09) and its detection algorithms in identifying AF compared to a nearly simultaneously acquired physician-interpreted 12-lead ECG in a real world cohort of patients.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Reducing the burden of inconclusive smart device single-lead ECG tracings via a novel artificial intelligence algorithm.
    Weidlich S, Mannhart D, Kennedy A, Doggart P, et al · · 2024 · cited 7× · PMID 38390580 · DOI 10.1016/j.cvdhj.2023.12.003
  2. Feasibility and accuracy of wearable electrocardiogram monitoring in adult congenital heart disease.
    Runge F, Brügger J, Ruperti-Repilado FJ, Subin B, et al · · 2025 · PMID 41061680 · DOI 10.1093/europace/euaf247
  3. Accuracy in detecting atrial fibrillation in single-lead ECGs: an online survey comparing the influence of clinical expertise and smart devices.
    Weidlich S, Mannhart D, Serban T, Krisai P, et al · · 2023 · PMID 37769610 · DOI 10.57187/smw.2023.40096

Verify or expand the search:

Other recruiting trials for Atrial Fibrillation (AF)

Currently open trials in the same condition.

Other University Hospital, Basel, Switzerland trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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