Clinical Performance of AFGen1

Study Overview
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Brief Summary
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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
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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 .

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

Conditions
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Afib, Atrial Fibrillation, ECG

Intervention / Treatment
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* Device: ECG co-measurement


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1. 18+ willing to sign the consent form Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Wear AFGen1<br>Wear AFGen1 for 7 days. ECG co-measurement with 12 lead device at start and end of wear period | Device: ECG co-measurement<br>* Measure ECG with 12 lead device at same time that AFGen1 is monitoring ECG<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quantitative Evaluation | For the quantitative evaluation of the mean and standard deviation of the QRS amplitude, duration, and timing correlations for all study subjects and for the end of the wear period for those relevant subjects, the mean correlation coefficient must be greater than 0.95 and standard deviation must be less than 0.05 to validate a 95% confidence interval with significant factor of assurance. validate a 95% confidence interval with significant factor of assurance. | 7 days | 
| Adhesive performance | For the adhesive performance element of the study, the overall average wear time for the device must be greater than 5-days. | 7 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ECG signal quality