Electrocardiogram Clinical Validation Study

Completed · Not applicable

Conditions studied: Atrial Fibrillation

In brief

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.

Key facts

Study ID

NCT03492554

Run by

Apple Inc.

People needed

602

Starts

2018-03-12

Expected to finish

2018-05-14

Last updated by the study team

2020-12-03

Who can join

Age: 22 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• QPS — Miami, Florida, United States
• BioClinicia- Orlando — Orlando, Florida, United States
• BioClinica- The Villages — The Villages, Florida, United States
• IQVIA — Overland Park, Kansas, United States
• Health East — Saint Paul, Minnesota, United States

Full record on ClinicalTrials.gov

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