Electrocardiogram Clinical Validation Study

Apple Inc.5 sites in 1 country602 target enrollmentMarch 12, 2018

ConditionsAtrial Fibrillation

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Atrial Fibrillation
Sponsor: Apple Inc.
Enrollment: 602
Locations: 5
Primary Endpoint: Number of Participants With Software's Rhythm Classification of AF in Agreement to a Physician's Interpretation of a Gold Standard 12-lead ECG
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

March 12, 2018

End Date

May 14, 2018

Last Updated

5 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Apple Inc.

Responsible Party

Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Number of Participants With Software's Rhythm Classification of AF in Agreement to a Physician's Interpretation of a Gold Standard 12-lead ECG

Time Frame: 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

Time Frame: 1 Day

Specificity of rhythm classification

Secondary Outcomes

Ease of Use(1 Day)
Number of Participants With Software's Ability to Produce a Clinically Equivalent Waveform in Agreement to a Gold Standard Lead 1 Reference(1 Day)