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

Completed

Conditions studied: Atrial Fibrillation, Afib, Irregular Heart Beat, Arrhythmias, Cardiac, Arrhythmia Atrial, Arrhythmias Paroxysmal, Paroxysmal Atrial Fibrillation

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

Key facts

Study ID

NCT05295056

Run by

TriVirum, Inc.

People needed

38

Starts

2022-05-12

Expected to finish

2023-08-25

Last updated by the study team

2023-09-28

Who can join

Age: 65 and older, up to 90. Sex: any. Healthy volunteers: not 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 instruc-tions 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

Where it is running

• Clayton Sleep Institute — St Louis, Missouri, United States

Full record on ClinicalTrials.gov

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