NCT06335498

Further Study of AFGen1 Clinical Performance

A Further Study of the Clinical Performance of AFGen1

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 20 (actual)
• Sponsor: TriVirum, Inc. · Industry
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Accepted

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 further evidence for 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 using a Bland-Altman analysis of the R-R intervals and R amplitude measurements and Eigenvector magnitudes derived from principal component analyses of simultaneously captured waveforms measured by both devices by both devices. The ECG waveforms from both devices will also be adjudicated by 2 independent cardiologists. The study will also seek to demonstrate that there is no degradation in the quality of the ECG signal it acquires when the device is placed in an anticipated misplacement position to that directed by the instructions for use of the device. Finally the study will seek 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 . Another purpose of the study is to collect extended 5 minute ECG recordings by the subject periodically triggering the device while wearing the device for 7 (+3) days. This data will be used for product development purposes.

Conditions

• Atrial Fibrillation
• Afib
• ECG

Interventions

Type	Name	Description
DEVICE	ECG co-measurement	Measure ECG with 12 lead device at same time that AFGen1 is monitoring ECG
DEVICE	Periodic ECG triggered measurement	Subject triggers AFGen1 to perform an extended measurement during wear period

Timeline

• Start date: 2024-04-02
• Primary completion: 2024-04-12
• Completion: 2024-04-19
• First posted: 2024-03-28
• Last updated: 2024-06-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study