NCT06076798

Clinical Performance of AFGen1

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 15 (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 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 .

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

Timeline

• Start date: 2023-10-05
• Primary completion: 2023-11-05
• Completion: 2023-11-24
• First posted: 2023-10-11
• Last updated: 2024-04-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study