Electrocardiogram Clinical Validation Study
- Conditions
- Atrial Fibrillation
- Interventions
- Diagnostic Test: Electrocardiogram
- Registration Number
- NCT04842123
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 568
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Atrial fibrillation (AF) Electrocardiogram Patients with a known history of AF who are in AF at the time of study screening. Normal Sinus Rhythm (SR) Electrocardiogram Patients with no known diagnosis of AF or other arrhythmia
- Primary Outcome Measures
Name Time Method Specificity of rhythm classification 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
Sensitivity of rhythm classification 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
Name Time Method Number of ECGs that pass a visual overlay Day 1 Number of participants with software's ability to produce a clinically equivalent waveform in agreement to a gold standard Lead I reference
Difference in R-wave amplitudes between the software and gold standard reference Day 1 Number of participants with software's ability to produce a clinically equivalent waveform in agreement to a gold standard Lead I reference
Trial Locations
- Locations (6)
HealthEast
🇺🇸Saint Paul, Minnesota, United States
MedStar Washington Hospital Center
🇺🇸Washington, District of Columbia, United States
Northwell Health Lenox Hill Hospital
🇺🇸New York, New York, United States
Northwell Health North Shore University Hospital
🇺🇸Manhasset, New York, United States
MedStar Health Cardiac Electrophysiology at Fairfax
🇺🇸Fairfax, Virginia, United States
Hope Research Institute
🇺🇸Phoenix, Arizona, United States