Clinical Performance of AFGen1

Completed

Conditions studied: Atrial Fibrillation, Afib, ECG

In brief

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.

Key facts

Study ID

NCT06076798

Run by

TriVirum, Inc.

People needed

15

Starts

2023-10-05

Expected to finish

2023-11-24

Last updated by the study team

2024-04-11

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 18+ willing to sign the consent form

You may not qualify if…

• 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

Where it is running

• 4927 Lillian Street — San Diego, California, United States

Full record on ClinicalTrials.gov

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