Atrial FibrillationGARMIN AFNCT03566836
Atrial Fibrillation Detection Using Garmin Wearable Technology
An observational study of Atrial Fibrillation, run by University of Kansas Medical Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Garmin Smart Watch and Garmin Chest Band
- Type of treatment
- Medical device
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Jun 2018to Jan 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who are receiving care from the University of Kansas Health System.
Who may be able to join
- All patients with AF scheduled to undergo electrical cardioversion at the University of Kansas Health System
Who cannot join
- Patients with no detectable PPG
- Hemodynamically unstable patients
- Patients who cannot give informed consent
- Patients with tattoos on the wrists
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of Kansas Medical Center
Kansas City, Kansas, 66160
Travis Love, MD
Bharath Yarlagadda, MD
About this study
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.
Read the 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.
- Conditions
- Atrial Fibrillation
- Being tested
- Garmin Smart Watch, Garmin Chest Band
- Keywords
- Smart Watch, Garmin, Wearable, Cardioversion
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Garmin Smart WatchDevice
Garmin Smart Watch
Garmin Chest BandDevice
Garmin Chest Band
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Garmin Smart Watch; Device: Garmin Chest Band |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and specificity of Garmin wearable device in detecting AF
PPG samples collected from Garmin wearable will be evaluated and calculated by Garmin custom
Measured: Visit 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2018
- Study start19 Jun 2018
- Primary completionJan 2020 (estimated)
- Study completionJan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Garmin International
- Responsible party
- Sponsor
- Investigators
- Yeruva Madhu Reddy, MD, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03566836
- Sponsor's protocol ID
- STUDY00142473
- Acronym
- GARMIN AF
- Status last verified
- Sep 2019
- First submitted
- 12 Jun 2018
- Last updated
- 4 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Atrial Fibrillation Detection Using Garmin Wearable Technology
- ClinicalTrials.gov ID
- NCT03566836
- Acronym / sponsor ID
- GARMIN AF / STUDY00142473
- Conditions
- Atrial Fibrillation
- Keywords
- Smart Watch, Garmin, Wearable, Cardioversion
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Collaborators
- Garmin International
- Study start
- 19 Jun 2018 (actual)
- Primary completion
- Jan 2020 (estimated)
- Study completion
- Jan 2020 (estimated)
- First posted
- 25 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AF Detection | – | Device: Garmin Smart Watch, Device: Garmin Chest BandParticipants 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who are receiving care from the University of Kansas Health System.
Key inclusion criteria (1 listed)
- All patients with AF scheduled to undergo electrical cardioversion at the University of Kansas Health System
Key exclusion criteria (4 listed)
- Patients with no detectable PPG
- Hemodynamically unstable patients
- Patients who cannot give informed consent
- Patients with tattoos on the wrists
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Garmin Smart WatchGarmin Smart Watch | Device | AF Detection |
| Garmin Chest BandGarmin Chest Band | Device | AF Detection |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2019.
- Individual participant dataSharing planned: Undecided
Related trials for Atrial Fibrillation
Active, not recruiting
VOLT CE Mark Study
Atrial Arrhythmia, Atrial Fibrillation
RecruitingObservational study
AI-Based Cardiac Analysis Using 12-Lead and 1-Lead ECG
Heart Failure, Atrial Fibrillation (AF)
RecruitingObservational study
Observational Study of Cardiac Arrhythmias During Treatment With BTK Inhibitors or Venetoclax
Chronic Lymphocytic Leukemia (CLL), Waldenstr(SqrRoot)(Delta)m s Macroglobulinemia
Not yet recruiting
CATCH AF - Atrial Fibrillation Detection in Cryptogenic Stroke
Atrial Fibrillation (AF)
Active, not recruiting
ARIADNE Clinical Trial
Persistent Atrial Fibrillation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yeruva Madhu Reddy, MD principal investigator
University of Kansas Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation, run by University of Kansas Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Margana Morgan (913-945-6443, mmorgan@kumc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity and specificity of Garmin wearable device in detecting AF (time frame: Visit 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2019.