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Electrocardiogram Clinical Validation Study

NCT03492554 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 602

Last updated 2020-12-03

Study results available
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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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Iqvia Pty Ltd

    collaborator INDUSTRY

  • Apple Inc.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-03-12
Primary Completion
2018-05-14
Completion
2018-05-14
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03492554 on ClinicalTrials.gov