Clinical Performance of AFGen1

Completed

• Conditions: Atrial Fibrillation; Afib; ECG
• Interventions: Device: ECG co-measurement

• Registration Number: NCT06076798
• Lead Sponsor: TriVirum, Inc.

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.

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 Timeline

• Study First Submitted: 2023-10-04
• Study First Submitted QC: 2023-10-04
• Study Start: 2023-10-05
• Study First Posted: 2023-10-11
• Primary Completion: 2023-11-05
• Study Completion: 2023-11-24
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-10
• Last Update Posted: 2024-04-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Wear AFGen1	ECG co-measurement	Wear AFGen1 for 7 days. ECG co-measurement with 12 lead device at start and end of wear period

Primary Outcome Measures

Name	Time	Method
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.
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.

Trial Locations

Locations (1)

4927 Lillian Street; 🇺🇸 San Diego, California, United States