Clinical Performance of AFGen1

April 10, 2024 updated by: TriVirum, Inc.

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 AFGen1 on human participants.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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 .

Study Type

Observational

Enrollment (Actual)

15

Contacts and Locations

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

Study Contact

Study Locations

  • United States
    • California
      • San Diego, California, United States, 92110
        • 4927 Lillian Street
        • Contact:
        • Principal Investigator:
          • Cynthia M Cadwell, MS BSN

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

The study shall involve 15 participants (approximately equal number of males and females, 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 instructions 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
  8. Known or suspected to be pregnant
  9. Student or employee of TriVirum

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Wear AFGen1
Wear AFGen1 for 7 days. ECG co-measurement with 12 lead device at start and end of wear period
Device: ECG co-measurement
Measure ECG with 12 lead device at same time that AFGen1 is monitoring 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 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.
7 days
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.
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)

October 5, 2023

Primary Completion (Actual)

November 5, 2023

Study Completion (Actual)

November 24, 2023

Study Registration Dates

First Submitted

October 4, 2023

First Submitted That Met QC Criteria

October 4, 2023

First Posted (Actual)

October 11, 2023

Study Record Updates

Last Update Posted (Actual)

April 11, 2024

Last Update Submitted That Met QC Criteria

April 10, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 130-0006P

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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