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Atrial Fibrillation Algorithms Clinical Validation Study

NCT04699812 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 573

Last updated 2022-08-24

Study results available
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Summary

The purpose of the study is to evaluate the performances of investigational Irregular Rhythm Notification Feature (version 2.0) and Atrial Fibrillation History Feature algorithms.

Conditions

Interventions

DEVICE

ELECTROCARDIOGRAM (ECG) PATCH WEAR

ALL PARTICIPANTS WILL WEAR AN ECG PATCH ON THEIR UPPER LEFT CHEST THROUGHOUT THE STUDY PARTICIPATION

Sponsors & Collaborators

  • Iqvia Pty Ltd

    collaborator INDUSTRY

  • Apple Inc.

    lead INDUSTRY

Principal Investigators

  • David Tsay, MD, PhD · Apple Inc.

Study Design

Allocation
NON_RANDOMIZED
Purpose
SCREENING
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-11-16
Primary Completion
2021-04-19
Completion
2021-12-17
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 NCT04699812 on ClinicalTrials.gov