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NCT03492554 · ClinicalTrials.gov registry record · NA

Electrocardiogram Clinical Validation Study

A NA study of Atrial Fibrillation, sponsored by Apple.

Completed
Registry status
NA
Development phase
602
Enrollment target
5
Study locations

NCT03492554 is a NA study of Atrial Fibrillation that has completed, run by Apple. The registered enrollment target is 602 participants, below the 2,994-participant average among 202 other Atrial Fibrillation trials with a reported enrollment target (80% lower). The trial reports 5 study locations across 3 states.

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The verdict

NCT03492554, a NA study of Atrial Fibrillation, has completed, sponsored by Apple.

COMPLETED
Registry status
NA
Development phase
602 participants
Enrollment target
5
Study locations

Study 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 Studied

Atrial Fibrillation

Interventions

  • OTHER 1-Lead ECG
  • DEVICE 12-Lead ECG

Study Locations (5)

Florida

  • QPS - Miami
  • BioClinicia- Orlando - Orlando
  • BioClinica- The Villages - The Villages

Kansas

  • IQVIA - Overland Park

Minnesota

  • Health East - Saint Paul

Trial Details

FieldValue
Enrollment Target 602 participants
Start Date 2018-03-12
Est. Completion 2018-05-14
Phase NA

Sponsor

Apple

12 total trials

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What the Registry Record Tells You About NCT03492554

The ClinicalTrials.gov registry entry for NCT03492554 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 602 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,994-participant average among 202 other Atrial Fibrillation trials with a reported enrollment target (80% lower). The listed sponsor is Apple, which has 12 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Atrial Fibrillation appearing as the primary indexed condition, and to 2 interventions - of which 1-Lead ECG is the first listed.

NCT03492554 reports 5 study locations spanning 3 distinct geographic areas - top geographies include Florida, Kansas, Minnesota.

Frequently Asked Questions

What is clinical trial NCT03492554 about?

NCT03492554 is a clinical study titled "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 A...

What is the current status of trial NCT03492554?

This trial is currently completed. It is a NA study. The enrollment target is 602 participants. The study started on 2018-03-12. Estimated completion is 2018-05-14.

What conditions does trial NCT03492554 study?

This clinical trial studies the following conditions: Atrial Fibrillation.

What interventions are being tested in trial NCT03492554?

The interventions under investigation include: 1-Lead ECG (OTHER), 12-Lead ECG (DEVICE).

Who is sponsoring clinical trial NCT03492554?

This trial is sponsored by Apple, which has 12 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03492554 being conducted?

This trial has 5 study locations across Florida, Kansas, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.