NCT04809922

Accuracy of Cardiac Wearables Devices to Detect Atrial Fibrillation

Accuracy of Cardiac Wearables Devices to Detect Atrial Fibrillation in a Real-World Cohort of Patients; BASEL Wearable Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 312 (actual)
• Sponsor: University Hospital, Basel, Switzerland · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2021-04-06
• Primary completion: 2024-01-31
• Completion: 2024-02-28
• First posted: 2021-03-22
• Last updated: 2024-03-01

Locations

1 site across 1 country: Switzerland