Electrocardiogram Clinical Validation Study
Status: | Completed |
---|---|
Conditions: | Atrial Fibrillation |
Therapuetic Areas: | Cardiology / Vascular Diseases |
Healthy: | No |
Age Range: | 22 - Any |
Updated: | 3/30/2019 |
Start Date: | March 12, 2018 |
End Date: | May 14, 2018 |
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.
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
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