Electrocardiogram Clinical Validation Study

Apple

Status

Completed

Conditions

Atrial Fibrillation

Treatments

Other: 1-Lead ECG

Device: 12-Lead ECG

Study type

Interventional

Funder types

Industry

Identifiers

NCT03492554

099-11774

Details and patient eligibility

About

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.

Enrollment

602 patients

Sex

All

Ages

22+ years old

Volunteers

Accepts Healthy Volunteers

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