Electrocardiogram Clinical Validation Study

Last updated: February 2, 2022
Sponsor: Garmin International
Overall Status: Completed

Phase

N/A

Condition

Arrhythmia

Dysrhythmia

Cardiac Disease

Treatment

N/A

Clinical Study ID

NCT04842123
ECG-002
  • Ages > 22
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Able to read, understand, and provide written informed consent;
  • Willing and able to participate in the study procedures as described in the consentform;
  • 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 ofAF and be in AF at the time of screening.

Exclusion

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 cardiovasculardisease that, in the opinion of the Investigator, increases the risk to the subject orrenders data uninterpretable;
  • Acute pulmonary embolism, pulmonary infarction, or deep vein thrombosis within 90 daysof 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 electrodeattachment sites, including known allergy or sensitivity to silicone bands primarilyused in wrist-worn fitness devices;
  • Known sensitivity to medical adhesives, isopropyl alcohol, watch bands, or ECGelectrodes;
  • 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.

Study Design

Total Participants: 568
Study Start date:
March 31, 2021
Estimated Completion Date:
October 04, 2021

Connect with a study center

  • Hope Research Institute

    Phoenix, Arizona 85018
    United States

    Site Not Available

  • MedStar Washington Hospital Center

    Washington, District of Columbia 20010
    United States

    Site Not Available

  • HealthEast

    Saint Paul, Minnesota 55102
    United States

    Site Not Available

  • Northwell Health North Shore University Hospital

    Manhasset, New York 11030
    United States

    Site Not Available

  • Northwell Health Lenox Hill Hospital

    New York, New York 10075
    United States

    Site Not Available

  • MedStar Health Cardiac Electrophysiology at Fairfax

    Fairfax, Virginia 22031
    United States

    Site Not Available

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