Atrial Fibrillation Detection Using Garmin Wearable Techn... | NCT03566836

Studies
Atrial Fibrillation Detection Using Garmin Wearable Technology

NCT03566836

Sponsor

University of Kansas Medical Center

Status

Unknown status

Last Update Posted

Sep 4, 2019Actual

Enrollment

120Estimated

Phase

Not provided

Conditions

Atrial Fibrillation

Interventions

Garmin Smart Watch
Garmin Chest Band

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 19, 2018Actual

Primary Completion Date

Jan 2020Estimated

Completion Date

Jan 2020Estimated

First Submitted Date

Jun 12, 2018

First Submission Date that Met QC Criteria

Jun 12, 2018

First Posted Date

Jun 25, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 3, 2019

Last Update Posted Date

Sep 4, 2019Actual

Name	Class
Garmin International	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

120Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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 Device: Garmin Chest Band

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Garmin Smart Watch	Device	Garmin Smart Watch	AF Detection
Garmin Chest Band

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Margana Morgan	Contact	913-945-6443		mmorgan@kumc.edu

Overall Officials

Name	Affiliation	Role
Yeruva Madhu Reddy, MD	University of Kansas Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Kansas Medical Center	Recruiting	Kansas City	Kansas	66160	United States

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001281	Atrial Fibrillation

Ancestor Terms

ID	Term
D001145	Arrhythmias, Cardiac
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D010335	Pathologic Processes

Browse Leaves

Not provided

Browse Branches

Not provided