Accuracy of Cardiac Wearables Devices to Detect Atrial Fibrillation

February 29, 2024 updated by: University Hospital, Basel, Switzerland

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

312

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Basel, Switzerland, 4031
        • Department of Cardiology, University Hospital Basel

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients undergoing electrophysiological study, pacemaker or implantable defibrillator (ICD) implantation or electric cardioversion at the University Hospital Basel.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
one time assessment at baseline
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
one time assessment at baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Basel, Switzerland

Investigators

  • Principal Investigator: Patrick Badertscher, Dr. med., Department of Cardiology, University Hospital Basel

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 6, 2021

Primary Completion (Actual)

January 31, 2024

Study Completion (Actual)

February 28, 2024

Study Registration Dates

First Submitted

March 18, 2021

First Submitted That Met QC Criteria

March 18, 2021

First Posted (Actual)

March 22, 2021

Study Record Updates

Last Update Posted (Actual)

March 1, 2024

Last Update Submitted That Met QC Criteria

February 29, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-02425; kt21Badertscher

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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