Electrocardiogram Clinical Validation Study

NCT04842123 | Completed FDA Device

• 1 other identifier: ECG-002
• Study Type: interventional
• Target: 568
• Locations: 1 country
• Sites: 6

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.

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Number of ECGs that pass a visual overlay

  Day 1

• Difference in R-wave amplitudes between the software and gold standard reference

  Day 1

Study Arms (2)

Atrial fibrillation (AF)

OTHER

Patients with a known history of AF who are in AF at the time of study screening.

Diagnostic Test: Electrocardiogram

Normal Sinus Rhythm (SR)

OTHER

Patients with no known diagnosis of AF or other arrhythmia

Diagnostic Test: Electrocardiogram

Interventions

Electrocardiogram DIAGNOSTIC_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.

Atrial fibrillation (AF); Normal Sinus Rhythm (SR)

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Garmin International: lead

Study Sites (6)

Hope Research Institute

Phoenix, Arizona, 85018, United States

Location

MedStar Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

HealthEast

Saint Paul, Minnesota, 55102, United States

Location

Northwell Health North Shore University Hospital

Manhasset, New York, 11030, United States

Location

Northwell Health Lenox Hill Hospital

New York, New York, 10075, United States

Location

MedStar Health Cardiac Electrophysiology at Fairfax

Fairfax, Virginia, 22031, United States

Location

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Electrocardiography

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2021
• First Posted: April 13, 2021
• Study Start: March 31, 2021
• Primary Completion: October 4, 2021
• Study Completion: October 4, 2021
• Last Updated: February 3, 2022

Record last verified: 2022-02

Locations

US (6)