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

Status Completed

Clinical Trial 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 the AFib-Chek device (a.k.a. Device) on human participants.

Clinical Trial Description

The primary purpose of this study is to demonstrate that the ECD signal acquired by the AFGen1 device is as of adequate quality and is suitable to support its intended use for the detection of AFib. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05295056
Study type	Observational
Source	TriVirum, Inc.
Contact
Status	Completed
Phase
Start date	May 12, 2022
Completion date	August 25, 2023

View Details

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