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

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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
We found this trial at
5
sites
Orlando, Florida 32806
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Orlando, FL
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Miami, Florida 33143
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Miami, FL
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Overland Park, Kansas 66211
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Overland Park, KS
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Saint Paul, Minnesota 55102
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Saint Paul, MN
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The Villages, Florida 32162
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The Villages, FL
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