Status:
COMPLETED
Electrocardiogram Clinical Validation Study
Lead Sponsor:
Garmin International
Conditions:
Atrial Fibrillation
Eligibility:
All Genders
22+ years
Phase:
NA
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 31 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 4 2021
Estimated Enrollment :
568 Patients enrolled
Trial Details
Trial ID
NCT04842123
Start Date
March 31 2021
End Date
October 4 2021
Last Update
February 3 2022
Active Locations (6)
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1
Hope Research Institute
Phoenix, Arizona, United States, 85018
2
MedStar Washington Hospital Center
Washington D.C., District of Columbia, United States, 20010
3
HealthEast
Saint Paul, Minnesota, United States, 55102
4
Northwell Health North Shore University Hospital
Manhasset, New York, United States, 11030