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

Not Applicable

Terminated

• Conditions: Atrial Fibrillation
• Interventions: Other: AFib detection with wearable smart watch

• Registration Number: NCT04499807
• Lead Sponsor: Kansas City Heart Rhythm Research Foundation

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.

Study Timeline

• Study First Submitted: 2020-07-29
• Study First Submitted QC: 2020-08-04
• Study First Posted: 2020-08-05
• Study Start: 2021-01-06
• Primary Completion: 2021-03-16
• Study Completion: 2021-03-16
• Status Verified: 2021-09
• Last Update Submitted: 2023-03-08
• Last Update Posted: 2023-03-10

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 16

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Smart Watch	AFib detection with wearable smart watch	The patients will wear the Smart Watch to generate data to assess their rhythm as confirmed by the ILR done during the same time.

Primary Outcome Measures

Name	Time	Method
AFib detection with heart rate data measured by Smart Watch	5 months	Heart rate data generated by Smart Watch is used to assess their rhythm as confirmed by the ILR done during the same time.

Trial Locations

Locations (1)

Kansas City Heart Rhythm Institute; 🇺🇸 Overland Park, Kansas, United States