Electrocardiogram Clinical Validation Study

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.

Study Overview

• Status: Completed
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Other: 1-Lead ECG; Device: 12-Lead ECG

• Study Type: Interventional
• Enrollment (Actual): 602
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33143
      • QPS
    • Orlando, Florida, United States, 32806
      • BioClinicia- Orlando
    • The Villages, Florida, United States, 32162
      • BioClinica- The Villages
  • Kansas
    • Overland Park, Kansas, United States, 66211
      • IQVIA
  • Minnesota
    • Saint Paul, Minnesota, United States, 55102
      • Health East

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Atrial fibrillation (AF); Patient with a known history of AF who are in AF at the time of study screening.	Other: 1-Lead ECG; All participants will record three single-lead ECGs; Device: 12-Lead ECG; All participants will simultaneously record three 12-lead ECGs
Other: Normal Sinus Rhythm (SR); Patient with no known diagnosis of AF or other arrhythmia	Other: 1-Lead ECG; All participants will record three single-lead ECGs; Device: 12-Lead ECG; All participants will simultaneously record three 12-lead ECGs

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Apple Inc.
• Collaborators: Iqvia Pty Ltd

Study record dates

Study Major Dates

• Study Start (Actual): March 12, 2018
• Primary Completion (Actual): May 14, 2018
• Study Completion (Actual): May 14, 2018

Study Registration Dates

• First Submitted: February 27, 2018
• First Submitted That Met QC Criteria: April 2, 2018
• First Posted (Actual): April 10, 2018

Study Record Updates

• Last Update Posted (Actual): December 3, 2020
• Last Update Submitted That Met QC Criteria: November 19, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: 099-11774

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes