Electrocardiogram Clinical Validation Study
1 other identifier
interventional
602
1 country
5
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable atrial-fibrillation
Started Mar 2018
Shorter than P25 for not_applicable atrial-fibrillation
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 27, 2018
CompletedStudy Start
First participant enrolled
March 12, 2018
CompletedFirst Posted
Study publicly available on registry
April 10, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 14, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
May 14, 2018
CompletedResults Posted
Study results publicly available
July 24, 2019
CompletedDecember 3, 2020
November 1, 2020
2 months
February 27, 2018
May 13, 2019
November 19, 2020
Conditions
Outcome Measures
Primary Outcomes (2)
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 Outcomes (3)
Number of Participants With Software's Ability to Produce a Clinically Equivalent Waveform in Agreement to a Gold Standard Lead 1 Reference
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
Ease of Use
1 Day
Study Arms (2)
Atrial fibrillation (AF)
OTHERPatient with a known history of AF who are in AF at the time of study screening.
Normal Sinus Rhythm (SR)
OTHERPatient with no known diagnosis of AF or other arrhythmia
Interventions
All participants will record three single-lead ECGs
All participants will simultaneously record three 12-lead ECGs
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Apple Inc.lead
- Iqvia Pty Ltdcollaborator
Study Sites (5)
QPS
Miami, Florida, 33143, United States
BioClinicia- Orlando
Orlando, Florida, 32806, United States
BioClinica- The Villages
The Villages, Florida, 32162, United States
IQVIA
Overland Park, Kansas, 66211, United States
Health East
Saint Paul, Minnesota, 55102, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Health Technology Clinical Operations
- Organization
- Apple
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 27, 2018
First Posted
April 10, 2018
Study Start
March 12, 2018
Primary Completion
May 14, 2018
Study Completion
May 14, 2018
Last Updated
December 3, 2020
Results First Posted
July 24, 2019
Record last verified: 2020-11
Data Sharing
- IPD Sharing
- Will not share