Atrial Fibrillation Detection Using Garmin Wearable Technology

Atrial Fibrillation Clinical Trial

— GARMIN AF  

Official title:

Atrial Fibrillation Detection Using Garmin Wearable Technology

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03566836
• Other study ID #: STUDY00142473
• Status: Recruiting
• Start date: June 19, 2018
• Est. completion date: January 2020

Study information

• Verified date: September 2019
• Source: University of Kansas Medical Center
• Contact: Margana Morgan
• Phone: 913-945-6443
• Email: mmorgan[@]kumc.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to evaluate the feasibility of detecting atrial fibrillation (AF) in patients with AF using a wearable wrist device/smart watch.

Description:

Even though AF is common and associated with increased risk of stroke, quite often it goes undetected until late in the course of the condition. If AF can be detected with simpler tools like a smart watch, it would enable providers to identify patients with AF much earlier in the course of the condition (even before being seen by a physician) and hopefully be able to prevent stroke. This study is being done to identify a technology that can likely identify AF using a smart watch.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: January 2020
• Est. primary completion date: January 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• All patients with AF scheduled to undergo electrical cardioversion at the University of Kansas Health System

Exclusion Criteria:

• Patients with no detectable PPG

• Hemodynamically unstable patients

• Patients who cannot give informed consent

• Patients with tattoos on the wrists

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Device:
• Garmin Smart Watch
Garmin Smart Watch
• Garmin Chest Band
Garmin Chest Band

Locations

Country	Name	City	State
United States	University of Kansas Medical Center	Kansas City	Kansas

Sponsors (2)

Lead Sponsor	Collaborator
University of Kansas Medical Center	Garmin International

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity and specificity of Garmin wearable device in detecting AF	PPG samples collected from Garmin wearable will be evaluated and calculated by Garmin custom	Visit 1