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Accuracy of Cardiac Wearables Devices to Detect Atrial Fibrillation

NCT04809922 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 312

Last updated 2024-03-01

No results posted yet for this study

Summary

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.

Conditions

  • Atrial Fibrillation (AF)

Interventions

DEVICE

cardiac wearable devices

five cardiac wearable devices * Apple Watch, Apple Inc., Model Number: A1977 / A1978 * Kardia Mobile, AliveCor Inc., AC-009/Kardia Mobile 6L, AliveCor Inc., AC-019 * Fitbit Sense, Fitbit, Inc, Model Number: FB512 * Samsung Galaxy Watch 3 Samsung Inc., Model Number: SM-R855F * Withings Scanwatch, Withings SA, Model Number: HWA09 Used for recording of one single-lead ECG. The results will be 274 compared to a simultaneous 12-lead ECG, which is considered the gold standard for detecting AF. There is no comparator in this trial.

Sponsors & Collaborators

  • University Hospital, Basel, Switzerland

    lead OTHER

Principal Investigators

  • Patrick Badertscher, Dr. med. · Department of Cardiology, University Hospital Basel

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-06
Primary Completion
2024-01-31
Completion
2024-02-28

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04809922 on ClinicalTrials.gov