Clinical Performance of AFGen1

Sponsor

TriVirum, Inc. (Industry)

Overall Status

Active, not recruiting

CT.gov ID

NCT06076798

Collaborator

(none)

Enrollment

Location

Anticipated Duration (Days)

16.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Atrial Fibrillation Afib ECG	Device: ECG co-measurement

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 Design

Study Type:

Observational

Anticipated Enrollment :

15 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Oct 5, 2023

Anticipated Primary Completion Date :

Nov 1, 2023

Anticipated Study Completion Date :

Nov 1, 2023

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

Quantitative Evaluation [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.
Adhesive performance [7 days]
For the adhesive performance element of the study, the overall average wear time for the device must be greater than 5-days.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	4927 Lillian Street	San Diego	California	United States	92110

Sponsors and Collaborators

TriVirum, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

TriVirum, Inc.

ClinicalTrials.gov Identifier:

NCT06076798

Other Study ID Numbers:

130-0006P

First Posted:

Oct 11, 2023

Last Update Posted:

Oct 16, 2023

Last Verified:

Oct 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Keywords provided by TriVirum, Inc.

ECG signal quality

Additional relevant MeSH terms:

Atrial Fibrillation

Study Results

No Results Posted as of Oct 16, 2023