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

Completed

• Conditions: Afib; Irregular Heart Beat; Arrhythmias Paroxysmal; Arrhythmias, Cardiac; Arrhythmia Atrial; Paroxysmal Atrial Fibrillation; Atrial Fibrillation
• Interventions: Device: AFGen1 Device Wear Test; Device: AFGen 1 Device Single Use

• Registration Number: NCT05295056
• Lead Sponsor: TriVirum, Inc.

Brief 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.

Detailed 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 Timeline

• Study First Submitted: 2022-03-15
• Study First Submitted QC: 2022-03-15
• Study First Posted: 2022-03-24
• Study Start: 2022-05-12
• Primary Completion: 2023-08-25
• Study Completion: 2023-08-25
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-26
• Last Update Posted: 2023-09-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

Inclusion Criteria

1. 18+ willing to sign the consent form

Exclusion Criteria

1. Implanted pacemakers
2. Implanted cardioverter defibrillators
3. Implanted cardiac resynchronization devices
4. Potential life-threatening arrythmias
5. Physical or mental health conditions that would prevent the person from being able to follow instruc-tions regarding participation in the study
6. Open wounds, abraded or irritated skin at the application site
7. Planned to undergo a MRI during the course of the study duration

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Healthy control	AFGen1 Device Wear Test	Healthy controls
Permanent atrial fibrillation	AFGen1 Device Wear Test	Known to have permanent atrial fibrillation
Healthy control	AFGen 1 Device Single Use	Healthy controls

Primary Outcome Measures

Name	Time	Method
Adhesive performance	7 days	For the adhe sive performance element of the stud y; t he overall average wear time for the de- vice must be greater than 5 days
Quantitative Evaluation	7 days	For the quantitative evaluation of the mean and standard deviation of the QRS correlations for all study subjects and for the end of the wear period for those relevant subjects, the mean cor- relation 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.
Qualitative Equivalence Evaluation	7 days	For the qualitative equivalence evaluation according to the two cardiologists the confirmation of equivalence must be greater than 95%.

Trial Locations

Locations (1)

Clayton Sleep Institute; 🇺🇸 Saint Louis, Missouri, United States