Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Garmin International
Age
22–any
Sex
ALL
Healthy volunteers
Accepted
You may be eligible 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 be 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.
Clareo Health | Electrocardiogram Clinical Validation Study
