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Electrocardiogram Clinical Validation Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04842123
Recruitment Status : Completed
First Posted : April 13, 2021
Last Update Posted : February 3, 2022
Sponsor:
Information provided by (Responsible Party):
Garmin International

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Diagnostic Test: Electrocardiogram Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 568 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Electrocardiogram Clinical Validation Study
Actual Study Start Date : March 31, 2021
Actual Primary Completion Date : October 4, 2021
Actual Study Completion Date : October 4, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Atrial fibrillation (AF)
Patients with a known history of AF who are in AF at the time of study screening.
Diagnostic Test: Electrocardiogram
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.

Normal Sinus Rhythm (SR)
Patients with no known diagnosis of AF or other arrhythmia
Diagnostic Test: Electrocardiogram
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.




Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. Number of ECGs that pass a visual overlay [ Time Frame: Day 1 ]
    Number of participants with software's ability to produce a clinically equivalent waveform in agreement to a gold standard Lead I reference

  2. Difference in R-wave amplitudes between the software and gold standard reference [ Time Frame: Day 1 ]
    Number of participants with software's ability to produce a clinically equivalent waveform in agreement to a gold standard Lead I reference



Information from the National Library of Medicine

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Ages Eligible for Study:   22 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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;
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04842123


Locations
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United States, Arizona
Hope Research Institute
Phoenix, Arizona, United States, 85018
United States, District of Columbia
MedStar Washington Hospital Center
Washington, District of Columbia, United States, 20010
United States, Minnesota
HealthEast
Saint Paul, Minnesota, United States, 55102
United States, New York
Northwell Health North Shore University Hospital
Manhasset, New York, United States, 11030
Northwell Health Lenox Hill Hospital
New York, New York, United States, 10075
United States, Virginia
MedStar Health Cardiac Electrophysiology at Fairfax
Fairfax, Virginia, United States, 22031
Sponsors and Collaborators
Garmin International
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Responsible Party: Garmin International
ClinicalTrials.gov Identifier: NCT04842123    
Other Study ID Numbers: ECG-002
First Posted: April 13, 2021    Key Record Dates
Last Update Posted: February 3, 2022
Last Verified: February 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes