Atrial Fibrillation Detection Using Garmin Wearable Technology (GARMIN AF)

September 3, 2019 updated by: University of Kansas Medical Center
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • Recruiting
        • University of Kansas Medical Center
        • Sub-Investigator:
          • Travis Love, MD
        • Sub-Investigator:
          • Bharath Yarlagadda, MD
        • Sub-Investigator:
          • Tawseef Dar, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients who are receiving care from the University of Kansas Health System.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensitivity and specificity of Garmin wearable device in detecting AF
Time Frame: Visit 1
PPG samples collected from Garmin wearable will be evaluated and calculated by Garmin custom
Visit 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Kansas Medical Center

Collaborators

Garmin International

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 19, 2018

Primary Completion (Anticipated)

January 1, 2020

Study Completion (Anticipated)

January 1, 2020

Study Registration Dates

First Submitted

June 12, 2018

First Submitted That Met QC Criteria

June 12, 2018

First Posted (Actual)

June 25, 2018

Study Record Updates

Last Update Posted (Actual)

September 4, 2019

Last Update Submitted That Met QC Criteria

September 3, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00142473

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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