Accuracy of Cardiac Wearables Devices to Detect Atrial Fibrillation

Study Overview
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Brief Summary
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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.

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

Conditions
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Atrial Fibrillation (AF)

Intervention / Treatment
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* Device: cardiac wearable devices


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart rhythm device accuracy of cardiac wearable devices | 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. | one time assessment at baseline | 
| Heart rhythm device accuracy of physician-interpreted iECG | Heart rhythm device accuracy of physician-interpreted iECG from a wearable device in detecting AF or SR compared to physician-interpreted 12-lead ECG | one time assessment at baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cardiac Wearables Devices, Sinus rhythm (SR), Lead-intelligent Electrocardiogram (iECG), heart rhythm device accuracy