Accuracy of Cardiac Wearables Devices to Detect Atrial Fibrillation in a Real-World Cohort of Patients; BASEL Wearable Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Atrial Fibrillation (AF)
- Sponsor
- University Hospital, Basel, Switzerland
- Enrollment
- 312
- Locations
- 1
- Primary Endpoint
- Heart rhythm device accuracy of physician-interpreted iECG
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Heart rhythm device accuracy of physician-interpreted iECG
Time Frame: 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
Time Frame: 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.