Clinical trial NCT03492554: Electrocardiogram Clinical Validation Study
Official title: Electrocardiogram Clinical Validation Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation
Lead sponsor: Apple Inc.
Sponsor class: INDUSTRY
Collaborators: name: Iqvia Pty Ltd
First posted: 2018-04-10
Enrollment: 602
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


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
* 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

Primary outcomes:
measure: Number of Participants With Software's Rhythm Classification of SR in Agreement to a Physician's Interpretation of a Gold Standard 12-lead ECG
timeFrame: 1 Day
measure: Number of Participants With Software's Rhythm Classification of AF in Agreement to a Physician's Interpretation of a Gold Standard 12-lead ECG
timeFrame: 1 Day
Secondary outcomes:
measure: Number of Participants With Software's Ability to Produce a Clinically Equivalent Waveform in Agreement to a Gold Standard Lead 1 Reference
timeFrame: 1 Day
measure: Number of Participants With Software's Ability to Produce a Clinically Equivalent Waveform in Agreement to a Gold Standard Lead 1 Reference
timeFrame: 1 Day
measure: Ease of Use
timeFrame: 1 Day
Other outcomes:
Locations:
city: Miami
country: United States
facility: QPS
state: Florida
city: Orlando
country: United States
facility: BioClinicia- Orlando
state: Florida
city: The Villages
country: United States
facility: BioClinica- The Villages
state: Florida
city: Overland Park
country: United States
facility: IQVIA
state: Kansas
city: Saint Paul
country: United States
facility: Health East
state: Minnesota
Study officials:
References: