Accuracy of Cardiac Wearables Devices to Detect Atrial Fibrillation

University Hospital, Basel, Switzerland312 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

312

Conditions

Atrial Fibrillation (AF)

Interventions

cardiac wearable devicesDEVICE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Department of Cardiology, University Hospital Basel

Basel, Switzerland

Outcomes

Primary Outcomes

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.

Time frame: 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

Time frame: one time assessment at baseline

Data from ClinicalTrials.gov

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