Accuracy of Cardiac Wearables Devices to Detect Atrial Fibrillation

NCT04809922 | Completed

• 1 other identifier: 2020-02425; kt21Badertscher
• Study Type: observational
• Target: 312
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Atrial Fibrillation (AF)

Keywords

Cardiac Wearables Devices; Sinus rhythm (SR); Lead-intelligent Electrocardiogram (iECG); heart rhythm device accuracy

Outcome Measures

Primary Outcomes (2)

• 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

Interventions

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (1)

Department of Cardiology, University Hospital Basel

Basel, 4031, Switzerland

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Patrick Badertscher, Dr. med.

  Department of Cardiology, University Hospital Basel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2021
• First Posted: March 22, 2021
• Study Start: April 6, 2021
• Primary Completion: January 31, 2024
• Study Completion: February 28, 2024
• Last Updated: March 1, 2024

Record last verified: 2024-02

Locations

CH (1)