Electrocardiogram Clinical Validation Study

Atrial Fibrillation Clinical Trial

Official title:

Electrocardiogram Clinical Validation Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04842123
• Other study ID #: ECG-002
• Status: Completed
• Phase: N/A
• Start date: March 31, 2021
• Est. completion date: October 4, 2021

Study information

• Verified date: February 2022
• Source: Garmin International
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 568
• Est. completion date: October 4, 2021
• Est. primary completion date: October 4, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 22 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

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.

Locations

Country	Name	City	State
United States	MedStar Health Cardiac Electrophysiology at Fairfax	Fairfax	Virginia
United States	Northwell Health North Shore University Hospital	Manhasset	New York
United States	Northwell Health Lenox Hill Hospital	New York	New York
United States	Hope Research Institute	Phoenix	Arizona
United States	HealthEast	Saint Paul	Minnesota
United States	MedStar Washington Hospital Center	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Garmin International

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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