Electrocardiogram Clinical Validation 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.

Study Overview

• Status: Completed
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Diagnostic test: Electrocardiogram

• Study Type: Interventional
• Enrollment (Actual): 568
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85018
      • Hope Research Institute
  • District of Columbia
    • Washington, District of Columbia, United States, 20010
      • MedStar Washington Hospital Center
  • Minnesota
    • Saint Paul, Minnesota, United States, 55102
      • Healtheast
  • New York
    • Manhasset, New York, United States, 11030
      • Northwell Health North Shore University Hospital
    • New York, New York, United States, 10075
      • Northwell Health Lenox Hill Hospital
  • Virginia
    • Fairfax, Virginia, United States, 22031
      • MedStar Health Cardiac Electrophysiology at Fairfax

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: 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.
OTHER: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	1 Day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	Day 1

Collaborators and Investigators

• Sponsor: Garmin International

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 31, 2021
• Primary Completion (ACTUAL): October 4, 2021
• Study Completion (ACTUAL): October 4, 2021

Study Registration Dates

• First Submitted: April 8, 2021
• First Submitted That Met QC Criteria: April 8, 2021
• First Posted (ACTUAL): April 13, 2021

Study Record Updates

• Last Update Posted (ACTUAL): February 3, 2022
• Last Update Submitted That Met QC Criteria: February 2, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: ECG-002

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No