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Electrocardiogram Clinical Validation Study

NCT ID: NCT03492554

Last Updated: 2020-12-03

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

602 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-12

Study Completion Date

2018-05-14

Brief Summary

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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.

Detailed Description

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Conditions

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Atrial Fibrillation

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Atrial fibrillation (AF)

Patient with a known history of AF who are in AF at the time of study screening.

Group Type OTHER

1-Lead ECG

Intervention Type OTHER

All participants will record three single-lead ECGs

12-Lead ECG

Intervention Type DEVICE

All participants will simultaneously record three 12-lead ECGs

Normal Sinus Rhythm (SR)

Patient with no known diagnosis of AF or other arrhythmia

Group Type OTHER

1-Lead ECG

Intervention Type OTHER

All participants will record three single-lead ECGs

12-Lead ECG

Intervention Type DEVICE

All participants will simultaneously record three 12-lead ECGs

Interventions

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1-Lead ECG

All participants will record three single-lead ECGs

Intervention Type OTHER

12-Lead ECG

All participants will simultaneously record three 12-lead ECGs

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

22 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Iqvia Pty Ltd

INDUSTRY

Sponsor Role collaborator

Apple Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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QPS

Miami, Florida, United States

Site Status

BioClinicia- Orlando

Orlando, Florida, United States

Site Status

BioClinica- The Villages

The Villages, Florida, United States

Site Status

IQVIA

Overland Park, Kansas, United States

Site Status

Health East

Saint Paul, Minnesota, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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099-11774

Identifier Type: -

Identifier Source: org_study_id