GARMIN AF: Atrial Fibrillation Detection Using Garmin Wearable Technology

• Sponsor: University of Kansas Medical Center (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03566836
• Collaborator: Garmin International (Industry)
• Enrollment: 120
• Location: 1
• Anticipated Duration (Months): 18.4
• Patients Per Site Per Month: 6.5

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Atrial Fibrillation	Device: Garmin Smart Watch; Device: Garmin Chest Band

Detailed 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.

Study Design

• Study Type: Observational
• Anticipated Enrollment: 120 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Atrial Fibrillation Detection Using Garmin Wearable Technology
• Actual Study Start Date: Jun 19, 2018
• Anticipated Primary Completion Date: Jan 1, 2020
• Anticipated Study Completion Date: Jan 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
AF Detection Participants will be asked to wear the Garmin smart watch and Garmin chest band. Both are commercially available. The devices will collect information about heart rates before and after a cardioversion procedure.	Device: Garmin Smart Watch; Garmin Smart Watch; Device: Garmin Chest Band; Garmin Chest Band

Outcome Measures

Primary Outcome Measures

1. Sensitivity and specificity of Garmin wearable device in detecting AF [Visit 1]

   PPG samples collected from Garmin wearable will be evaluated and calculated by Garmin custom

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Kansas Medical Center	Kansas City	Kansas	United States	66160

Sponsors and Collaborators

• University of Kansas Medical Center
• Garmin International

Investigators

• Principal Investigator: Yeruva Madhu Reddy, MD, University of Kansas Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Kansas Medical Center
• ClinicalTrials.gov Identifier: NCT03566836
• Other Study ID Numbers: STUDY00142473
• First Posted: Jun 25, 2018
• Last Update Posted: Sep 4, 2019
• Last Verified: Sep 1, 2019

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by University of Kansas Medical Center: Smart Watch; Garmin; Wearable; Cardioversion
• Additional relevant MeSH terms: Atrial Fibrillation

Study Results

No Results Posted as of Sep 4, 2019