Accuracy of Cardiac Wearables Devices to Detect Atrial Fibrillation

• Sponsor: University Hospital, Basel, Switzerland (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04809922
• Collaborator: (none)
• Enrollment: 334
• Location: 1
• Anticipated Duration (Months): 23.8
• Patients Per Site Per Month: 14

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Atrial Fibrillation (AF)	Device: cardiac wearable devices

Study Design

• Study Type: Observational
• Anticipated Enrollment: 334 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Accuracy of Cardiac Wearables Devices to Detect Atrial Fibrillation in a Real-World Cohort of Patients; BASEL Wearable Study
• Actual Study Start Date: Apr 6, 2021
• Anticipated Primary Completion Date: Apr 1, 2023
• Anticipated Study Completion Date: Apr 1, 2023

Outcome Measures

Primary Outcome Measures

1. Heart rhythm device accuracy of cardiac wearable devices [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.

2. Heart rhythm device accuracy of physician-interpreted iECG [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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Cardiology, University Hospital Basel	Basel		Switzerland	4031

Sponsors and Collaborators

• University Hospital, Basel, Switzerland

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University Hospital, Basel, Switzerland
• ClinicalTrials.gov Identifier: NCT04809922
• Other Study ID Numbers: 2020-02425; kt21Badertscher
• First Posted: Mar 22, 2021
• Last Update Posted: Oct 20, 2021
• Last Verified: Oct 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by University Hospital, Basel, Switzerland: Cardiac Wearables Devices; Sinus rhythm (SR); Lead-intelligent Electrocardiogram (iECG); heart rhythm device accuracy
• Additional relevant MeSH terms: Atrial Fibrillation

Study Results

No Results Posted as of Oct 20, 2021