Accuracy of Cardiac Wearables Devices to Detect Atrial Fibrillation

Completed

• Conditions: Atrial Fibrillation (AF)

• Registration Number: NCT04809922
• Lead Sponsor: University Hospital, Basel, Switzerland

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-03-18
• Study First Submitted QC: 2021-03-18
• Study First Posted: 2021-03-22
• Study Start: 2021-04-06
• Primary Completion: 2024-01-31
• Status Verified: 2024-02
• Study Completion: 2024-02-28
• Last Update Submitted: 2024-02-29
• Last Update Posted: 2024-03-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 312

Inclusion Criteria

• All consecutive patients undergoing electrophysiological study, pacemaker or implantable defibrillator (ICD) implantation or electric cardioversion at the University Hospital Basel are eligible for study participation and will be asked to participate

Exclusion Criteria

• Use of a radial artery graft for coronary artery bypass grafting
• Tattoos located on the skin of the wrist or forearm where wearable device will be placed
• Patients receiving hemodialysis through arteriovenous fistula in the upper extremities
• Patients with inability to communicate and comply with all study requirements
• Patients who refused to participate in the trial

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Heart rhythm device accuracy of physician-interpreted iECG	one time assessment at baseline	Heart rhythm device accuracy of physician-interpreted iECG from a wearable device in detecting AF or SR compared to physician-interpreted 12-lead ECG
Heart rhythm device accuracy of cardiac wearable devices	one time assessment at baseline	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) in detecting AF compared to nearly simultaneously acquired physician interpreted 12-lead ECG.

Trial Locations

Locations (1)

Department of Cardiology, University Hospital Basel; 🇨🇭 Basel, Switzerland