Clinical trial NCT04499807: Accuracy of Rhythm Detection by a Wearable Smart Watch for Cardiac Arrhythmias (The WATCH-RHYTHM Study)
Official title: Accuracy of Rhythm Detection and Managing Data Deluge by a Wearable Smart Watch for Cardiac Arrhythmias (The WATCH-RHYTHM Study)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Atrial Fibrillation
Keywords: Wearable technology
Smart Watch
ILR
AFib detection
Lead sponsor: Kansas City Heart Rhythm Research Foundation
Sponsor class: OTHER
First posted: 2020-08-05
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: AFib detection with heart rate data measured by Smart Watch
timeFrame: 5 months
Secondary outcomes:
Other outcomes:
Locations:
city: Overland Park
country: United States
facility: Kansas City Heart Rhythm Institute
state: Kansas
Study officials:
affiliation: Kansas City Heart Rhythm Institute
name: Dhanunjaya Lakkireddy
role: PRINCIPAL_INVESTIGATOR
References:
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