Accuracy of Rhythm Detection and Managing Data Deluge by a Wearable Smart Watch for Cardiac Arrhythmias (The WATCH-RHYTHM Study)

Kansas City Heart Rhythm Research Foundation1 site in 1 country16 target enrollmentJanuary 6, 2021

ConditionsAtrial Fibrillation

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Atrial Fibrillation
Sponsor: Kansas City Heart Rhythm Research Foundation
Enrollment: 16
Locations: 1
Primary Endpoint: AFib detection with heart rate data measured by Smart Watch
Status: Terminated
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

It is an attempt to see the reliability of the Wearable Smart Watch in identifying atrial fibrillation and other arrhythmias compared to the data detected from ILRs.

Detailed Description

The sensitivity, specificity, positive and negative predictive values for successful identification of normal sinus rhythm, atrial fibrillation and other rhythm disorders from the smart watch will compared to that of an ILR.

Registry

clinicaltrials.gov

Start Date

January 6, 2021

End Date

March 16, 2021

Last Updated

3 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Kansas City Heart Rhythm Research Foundation

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Age over 18 years old
•Patients who have an implantable loop recorder for heart rhythm monitoring purposes
•Having IOS iphone device that can be integrated into Apple Watch
•Willing to sign a consent form and participate in the study

Exclusion Criteria

•Hemodynamically unstable patients
•Over 90 years of age
•Presence of wrist tattoos
•Presence of AV fistula on the wrist on which the wearable is worn. (If the contralateral wrist is unaffected, those patients can be included)
•Presence of Implantable Cardiac Pacemaker and/or ICD
•Patients with Parkinsons disease or tremors