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

Kansas City Heart Rhythm Research Foundation

Status: Terminated

Conditions: Atrial Fibrillation

Treatments: Other: AFib detection with wearable smart watch

Study type: Interventional

Funder types: Other

Identifiers

NCT04499807

KCHRF-WATCH RHYTHM-0006

Details and patient eligibility

About

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.

Full 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.

Enrollment: 16 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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16 participants in 1 patient group

Smart Watch

Other group

Description:

The patients will wear the Smart Watch to generate data to assess their rhythm as confirmed by the ILR done during the same time.

Treatment:

Other: AFib detection with wearable smart watch