Accuracy of Cardiac Wearables Devices to Detect Atrial Fibrillation

Atrial Fibrillation (AF) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04809922
• Other study ID #: 2020-02425; kt21Badertscher
• Status: Completed
• Start date: April 6, 2021
• Est. completion date: February 28, 2024

Study information

• Verified date: February 2024
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 312
• Est. completion date: February 28, 2024
• Est. primary completion date: January 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Atrial Fibrillation (AF)

Intervention

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.

Locations

Country	Name	City	State
Switzerland	Department of Cardiology, University Hospital Basel	Basel

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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