Electrocardiogram Clinical Validation Study

Electrocardiogram Clinical Validation Study

The purpose of the study is to confirm the software's ability to create a Lead-1 electrocardiogram (ECG) that is clinically equivalent to a reference device. Also, to confirm a rhythm classification algorithm and its ability to detect and classify heart rhythms into two categories (Sinus Rhythm or Atrial Fibrillation) using a single Lead ECG.

Inclusion Criteria:

• Individuals who are 22 years of age and older
• Able to read, understand, and provide written informed consent
• Willing and able to participate in the study procedures as described in the consent
• Have a wrist circumference that fits within the band
• Able to communicate effectively with and follow instructions from the study staff
• 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 (MI) 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
• Known sensitivity to medical adhesives, isopropyl alcohol, watch bands, or electrocardiogram (ECG) electrodes including known allergy or sensitivity to fluoroelastomer bands primarily used in wrist worn fitness devices
• A history of abnormal life-threatening rhythms as determined by the investigator
• Significant tremor that prevents subject from being able to hold still
• Pregnant women: Women who are pregnant at the time of study participation
• For subjects enrolled into the sinus rhythm population, they must not have any diagnosis of AF