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

September 26, 2023 updated by: TriVirum, Inc.
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

38

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • Saint Louis, Missouri, United States, 63123
        • Clayton Sleep Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

61 years to 86 years (Older Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

The study shall involve approximately 30-50 participants (approximately equal number of males and females, equal number with BMI < and > 35) meeting inclusion and exclusion criteria.

Description

Inclusion Criteria:

1. 18+ willing to sign the consent form

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Permanent atrial fibrillation
Known to have permanent atrial fibrillation
Device: AFGen1 Device Wear Test
Participant wears the device for 7 days
Healthy control
Healthy controls
Device: AFGen1 Device Wear Test
Participant wears the device for 7 days
Device: AFGen 1 Device Single Use
Participant wears the device in conjunction with a standard ECG

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
7 days
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%.
7 days
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
7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

TriVirum, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 12, 2022

Primary Completion (Actual)

August 25, 2023

Study Completion (Actual)

August 25, 2023

Study Registration Dates

First Submitted

March 15, 2022

First Submitted That Met QC Criteria

March 15, 2022

First Posted (Actual)

March 24, 2022

Study Record Updates

Last Update Posted (Actual)

September 28, 2023

Last Update Submitted That Met QC Criteria

September 26, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AFib-Chek-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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