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Electrocardiogram Clinical Validation Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03492554
Recruitment Status : Completed
First Posted : April 10, 2018
Results First Posted : July 24, 2019
Last Update Posted : July 24, 2019
Sponsor:
Collaborator:
Iqvia Pty Ltd
Information provided by (Responsible Party):
Apple Inc.

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.

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Other: 1-Lead ECG Device: 12-Lead ECG Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 602 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Electrocardiogram Clinical Validation Study
Actual Study Start Date : March 12, 2018
Actual Primary Completion Date : May 14, 2018
Actual Study Completion Date : May 14, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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

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




Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. Number of Participants With Software's Ability to Produce a Clinically Equivalent Waveform in Agreement to a Gold Standard Lead 1 Reference [ Time Frame: 1 Day ]
    Number of ECGs that pass a visual overlay

  2. Number of Participants With Software's Ability to Produce a Clinically Equivalent Waveform in Agreement to a Gold Standard Lead 1 Reference [ Time Frame: 1 Day ]
    Difference in R-wave amplitudes between the software and gold standard reference

  3. Ease of Use [ Time Frame: 1 Day ]
    Average ease of use on a 1 (Unable to Use) to 5 (Easiest to Use) scale



Information from the National Library of Medicine

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Ages Eligible for Study:   22 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03492554


Locations
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United States, Florida
QPS
Miami, Florida, United States, 33143
BioClinicia- Orlando
Orlando, Florida, United States, 32806
BioClinica- The Villages
The Villages, Florida, United States, 32162
United States, Kansas
IQVIA
Overland Park, Kansas, United States, 66211
United States, Minnesota
Health East
Saint Paul, Minnesota, United States, 55102
Sponsors and Collaborators
Apple Inc.
Iqvia Pty Ltd
  Study Documents (Full-Text)

Documents provided by Apple Inc.:
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Responsible Party: Apple Inc.
ClinicalTrials.gov Identifier: NCT03492554    
Other Study ID Numbers: 099-11774
First Posted: April 10, 2018    Key Record Dates
Results First Posted: July 24, 2019
Last Update Posted: July 24, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes