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OpenTrials
Completed

NCT Number: NCT05295056

Clinical Performance of the AFGen1 Device Over a 7-day Period

AFGen1 is indicated for use on symptomatic or asymptomatic adults who are at risk of developing or who have atrial fibrillation, where a software assisted analysis of ambulatory ECG is needed to identify episodes of Afib. The purpose of this study is to establish the clinical performance of the AFib-Chek device (a.k.a. Device) on human participants.

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Key information

Conditions

Atrial Fibrillation Afib Arrhythmia Atrial Arrhythmias Paroxysmal Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Irregular Heart Beat Paroxysmal Atrial Fibrillation Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

65 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Clayton Sleep Institute

St Louis, Missouri, 63123, United States

About this study

The primary purpose of this study is to demonstrate that the ECD signal acquired by the AFGen1 device is as of adequate quality and is suitable to support its intended use for the detection of AFib.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18+ willing to sign the consent form

Exclusion criteria

  • Implanted pacemakers
  • Implanted cardioverter defibrillators
  • Implanted cardiac resynchronization devices
  • Potential life-threatening arrythmias
  • Physical or mental health conditions that would prevent the person from being able to follow instruc-tions regarding participation in the study
  • Open wounds, abraded or irritated skin at the application site
  • Planned to undergo a MRI during the course of the study duration

Treatment and study plan

AFGen1 Device Wear Test

Device

Participant wears the device for 7 days

AFGen 1 Device Single Use

Device

Participant wears the device in conjunction with a standard ECG

Primary outcomes

  1. Quantitative Evaluation

    Time frame: 7 days

    For the quantitative evaluation of the mean and standard deviation of the QRS correlations for all study subjects and for the end of the wear period for those relevant subjects, the mean cor- relation coefficient must be greater than 0.95 and standard deviation must be less than 0.05 to validate a 95% confidence interval with significant factor of assurance.

  2. Qualitative Equivalence Evaluation

    Time frame: 7 days

    For the qualitative equivalence evaluation according to the two cardiologists the confirmation of equivalence must be greater than 95%.

  3. Adhesive performance

    Time frame: 7 days

    For the adhe sive performance element of the stud y; t he overall average wear time for the de- vice must be greater than 5 days

Sponsors and collaborators

Lead sponsor

TriVirum, Inc.

Industry

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Mar 24, 2022
Registry last updated
Sep 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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