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OpenTrials
Completed

NCT Number: NCT06076798

Clinical Performance of AFGen1

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 AFGen1 on human participants.

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Key information

Conditions

Atrial Fibrillation Afib Arrhythmias, Cardiac Cardiovascular Diseases ECG Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

4927 Lillian Street

San Diego, California, 92110, United States

About this study

The primary purpose of this study is to demonstrate the ECG signal acquired by the AFGen1 device is of adequate quality and is suitable to support its intended use for the detection of Afib. This will be evaluated by comparing the ECG data acquired by AFGen1 to that acquired by an FDA cleared 12-lead ECG device. The study will also seek to demonstrate that there is no degradation in the quality of the ECG signal it acquires over the maximum 7-day wear period that it can be prescribed for use.

The secondary purpose of this study is to confirm the adhesive performance of the device is appropriate to support its intended use per the requirements of sections 4.4 and 5.4 of ANSI AAMI EC12-1 .

Who can participate

Healthy volunteers accepted: Yes

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 instructions 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
  • Known or suspected to be pregnant
  • Student or employee of TriVirum

Treatment and study plan

ECG co-measurement

Device

Measure ECG with 12 lead device at same time that AFGen1 is monitoring ECG

Primary outcomes

  1. Quantitative Evaluation

    Time frame: 7 days

    For the quantitative evaluation of the mean and standard deviation of the QRS amplitude, duration, and timing correlations for all study subjects and for the end of the wear period for those relevant subjects, the mean correlation 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.

    validate a 95% confidence interval with significant factor of assurance.

  2. Adhesive performance

    Time frame: 7 days

    For the adhesive performance element of the study, the overall average wear time for the device must be greater than 5-days.

Sponsors and collaborators

Lead sponsor

TriVirum, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Oct 11, 2023
Registry last updated
Apr 11, 2024

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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