Atrial FibrillationNCT04842123
Electrocardiogram Clinical Validation Study
A study testing Electrocardiogram in people with Atrial Fibrillation, run by Garmin International at 6 sites in United States.
Trial summary
The purpose of the study is to confirm the Garmin ECG (electrocardiogram) software algorithm can detect and classify atrial fibrillation and normal sinus rhythm on single lead ECG data derived from a Garmin wrist-worn, consumer device. Read more about this study
- Who is it for?
- Ages 22 years and olderHealthy volunteers can take part
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Electrocardiogram
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 568 participants
- Where
- 6 sitesUnited States
- Study dates
- 31 Mar 2021to 4 Oct 2021
- Phase
- Interventional
- 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 22 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Able to read, understand, and provide written informed consent;
- Willing and able to participate in the study procedures as described in the consent form;
- Individuals who are 22 years of age and older;
- Able to communicate effectively with and follow instructions from the study staff;
- Have a wrist circumference that fits within the device band; and
- For subjects enrolled into the AF population, subjects must have a known diagnosis of AF and be in AF at the time of screening.
Who cannot join
- Physical disability that precludes safe and adequate testing;
- Mental impairment resulting in limited ability to cooperate;
- Subjects with a pacemaker or implantable cardioverter-defibrillator (ICD);
- Acute myocardial infarction within 90 days of screening or other cardiovascular disease that, in the opinion of the Investigator, increases the risk to the subject or renders data uninterpretable;
- Acute pulmonary embolism, pulmonary infarction, or deep vein thrombosis within 90 days of screening;
- Stroke or transient ischemic attack within 90 days of screening;
Show all 13Show fewer
- Subjects taking rhythm control drugs;
- Symptomatic (or active) allergic skin reactions such as eczema, rosacea, impetigo, dermatomyositis, or allergic contact dermatitis on both wrists or over electrode attachment sites, including known allergy or sensitivity to silicone bands primarily used in wrist-worn fitness devices;
- Known sensitivity to medical adhesives, isopropyl alcohol, watch bands, or ECG electrodes;
- A history of abnormal life-threatening rhythms as determined by the Investigator;
- Significant tremor that prevents subject from being able to hold still;
- Women who are pregnant at the time of study participation; and
- Subjects enrolled into the SR population must not have any diagnosis of AF.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
MedStar Health Cardiac Electrophysiology at Fairfax
Fairfax, Virginia, 22031
Northwell Health North Shore University Hospital
Manhasset, New York, 11030
Northwell Health Lenox Hill Hospital
New York, New York, 10075
Hope Research Institute
Phoenix, Arizona, 85018
HealthEast
Saint Paul, Minnesota, 55102
MedStar Washington Hospital Center
Washington D.C., District of Columbia, 20010
About this study
The purpose of the study is to confirm the Garmin ECG (electrocardiogram) software algorithm can detect and classify atrial fibrillation and normal sinus rhythm on single lead ECG data derived from a Garmin wrist-worn, consumer device. The study will also confirm the software's ability to create a Lead I ECG that is clinically equivalent to a reference device. The Garmin ECG software is not a diagnostic system and is intended for informational purposes only.
- Conditions
- Atrial Fibrillation
- Being tested
- Electrocardiogram
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ElectrocardiogramDiagnostic test
Simultaneous assessment of the heart rhythm determined from a 12-lead ECG and the Garmin ECG software algorithm heart rhythm classification on single-lead ECG data derived from the wearable device. All participants will record three simultaneous 12-lead and single-lead ECGs.
| Study group | Role | What they receive |
|---|---|---|
| Atrial fibrillation (AF) | Other | Patients with a known history of AF who are in AF at the time of study screening. Receives: Diagnostic Test: Electrocardiogram |
| Normal Sinus Rhythm (SR) | Other | Patients with no known diagnosis of AF or other arrhythmia Receives: Diagnostic Test: Electrocardiogram |
What is being measured
The primary outcome is the main question the study is designed to answer.
Specificity of rhythm classification
Number of participants with a SR software rhythm classification in agreement with a physician's interpretation of heart rhythm based on gold standard 12-lead ECG
Measured: 1 Day
Sensitivity of rhythm classification
Number of participants with an AF software rhythm classification in agreement with a physician's interpretation of heart rhythm based on gold standard 12-lead ECG
Measured: 1 Day
Secondary outcomes (2)
Number of ECGs that pass a visual overlay
Number of participants with software's ability to produce a clinically equivalent waveform in agreement to a gold standard Lead I reference
Measured: Day 1
Difference in R-wave amplitudes between the software and gold standard reference
Number of participants with software's ability to produce a clinically equivalent waveform in agreement to a gold standard Lead I reference
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2021
- Study start31 Mar 2021
- Primary completion4 Oct 2021
- Study completion4 Oct 2021
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 568 participants (actual)
Sponsor and investigators
- Lead sponsor
- Garmin International
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04842123
- Sponsor's protocol ID
- ECG-002
- Status last verified
- Feb 2022
- First submitted
- 8 Apr 2021
- Last updated
- 3 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electrocardiogram Clinical Validation Study
- ClinicalTrials.gov ID
- NCT04842123
- Acronym / sponsor ID
- ECG-002
- Conditions
- Atrial Fibrillation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 568 participants (actual)
- Lead sponsor
- Garmin InternationalIndustry (pharma, biotech, devices)
- Study start
- 31 Mar 2021 (actual)
- Primary completion
- 4 Oct 2021 (actual)
- Study completion
- 4 Oct 2021 (actual)
- First posted
- 13 Apr 2021 (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 the study is to confirm the Garmin ECG (electrocardiogram) software algorithm can detect and classify atrial fibrillation and normal sinus rhythm on single lead ECG data derived from a Garmin wrist-worn, consumer device. The study will also confirm the software's ability to create a Lead I ECG that is clinically equivalent to a reference device. The Garmin ECG software is not a diagnostic system and is intended for informational purposes only.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Atrial fibrillation (AF) | Other | Diagnostic Test: ElectrocardiogramPatients with a known history of AF who are in AF at the time of study screening. |
| Normal Sinus Rhythm (SR) | Other | Diagnostic Test: ElectrocardiogramPatients with no known diagnosis of AF or other arrhythmia |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Able to read, understand, and provide written informed consent;
- Willing and able to participate in the study procedures as described in the consent form;
- Individuals who are 22 years of age and older;
- Able to communicate effectively with and follow instructions from the study staff;
- Have a wrist circumference that fits within the device band; and
Key exclusion criteria (13 listed)
- Physical disability that precludes safe and adequate testing;
- Mental impairment resulting in limited ability to cooperate;
- Subjects with a pacemaker or implantable cardioverter-defibrillator (ICD);
- Acute myocardial infarction within 90 days of screening or other cardiovascular disease that, in the opinion of the Investigator, increases the risk to the subject or renders data uninterpretable;
- Acute pulmonary embolism, pulmonary infarction, or deep vein thrombosis within 90 days of screening;
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 |
|---|---|---|
| ElectrocardiogramSimultaneous assessment of the heart rhythm determined from a 12-lead ECG and the Garmin ECG software algorithm heart rhythm classification on single-lead ECG data derived from the wearable device. All participants will record three simultaneous 12-lead and single-lead ECGs. | Diagnostic test | Atrial fibrillation (AF), Normal Sinus Rhythm (SR) |
Primary outcome
Specificity of rhythm classification
Time frame: 1 Day
Number of participants with a SR software rhythm classification in agreement with a physician's interpretation of heart rhythm based on gold standard 12-lead ECG
Sensitivity of rhythm classification
Time frame: 1 Day
Number of participants with an AF software rhythm classification in agreement with a physician's interpretation of heart rhythm based on gold standard 12-lead ECG
2 secondary outcomes
Number of ECGs that pass a visual overlay
Time frame: Day 1
Difference in R-wave amplitudes between the software and gold standard reference
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electrocardiogram in people with Atrial Fibrillation, run by Garmin International at 6 sites 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 6 inclusion and 13 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: finished, as of the sponsor's last update on 3 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Specificity of rhythm classification (time frame: 1 Day). The study lists 2 primary outcomes in all. 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 3 Feb 2022.