Accuracy of Cardiac Wearables Devices to Detect Atrial Fibrillation

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.

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Key information

Conditions

Atrial Fibrillation (AF) Arrhythmias, Cardiac Atrial Fibrillation Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Cardiology, University Hospital Basel

Basel, 4031, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

cardiac wearable devices

Device

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.

Primary outcomes

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.
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

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Registry information

Official study title

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

Important dates

Study start: 2021
Primary completion: 2024
Study completion: 2024
First posted: Mar 22, 2021
Registry last updated: Mar 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed