Electrocardiogram Clinical Validation Study

Not Applicable

Completed

Brief Summary: 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Atrial fibrillation (AF)	12-Lead ECG	Patient with a known history of AF who are in AF at the time of study screening.
Normal Sinus Rhythm (SR)	1-Lead ECG	Patient with no known diagnosis of AF or other arrhythmia
Atrial fibrillation (AF)	1-Lead ECG	Patient with a known history of AF who are in AF at the time of study screening.
Normal Sinus Rhythm (SR)	12-Lead ECG	Patient with no known diagnosis of AF or other arrhythmia

Primary Outcome Measures

Name	Time	Method
Number of Participants With Software's Rhythm Classification of AF in Agreement to a Physician's Interpretation of a Gold Standard 12-lead ECG	1 Day	Sensitivity of rhythm classification
Number of Participants With Software's Rhythm Classification of SR in Agreement to a Physician's Interpretation of a Gold Standard 12-lead ECG	1 Day	Specificity of rhythm classification

Secondary Outcome Measures

Name	Time	Method
Ease of Use	1 Day	Average ease of use on a 1 (Unable to Use) to 5 (Easiest to Use) scale
Number of Participants With Software's Ability to Produce a Clinically Equivalent Waveform in Agreement to a Gold Standard Lead 1 Reference	1 Day	Difference in R-wave amplitudes between the software and gold standard reference

Locations (5): Health East
🇺🇸
Saint Paul, Minnesota, United States
IQVIA
🇺🇸
Overland Park, Kansas, United States
QPS
🇺🇸
Miami, Florida, United States
BioClinicia- Orlando
🇺🇸
Orlando, Florida, United States
BioClinica- The Villages
🇺🇸
The Villages, Florida, United States