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

NCT05295056 | Completed FDA Device

• 1 other identifier: AFib-Chek-001
• Study Type: observational
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation; Afib; Irregular Heart Beat; Arrhythmias, Cardiac; Arrhythmia Atrial; Arrhythmias Paroxysmal; Paroxysmal Atrial Fibrillation

Outcome Measures

Primary Outcomes (3)

• Quantitative Evaluation

  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.

  7 days

• Qualitative Equivalence Evaluation

  For the qualitative equivalence evaluation according to the two cardiologists the confirmation of equivalence must be greater than 95%.

  7 days

• Adhesive performance

  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

  7 days

Study Arms (2)

Permanent atrial fibrillation

Known to have permanent atrial fibrillation

Device: AFGen1 Device Wear Test

Healthy control

Healthy controls

Device: AFGen1 Device Wear Test; Device: AFGen 1 Device Single Use

Interventions

AFGen1 Device Wear Test DEVICE

Participant wears the device for 7 days

Healthy control; Permanent atrial fibrillation

AFGen 1 Device Single Use DEVICE

Participant wears the device in conjunction with a standard ECG

Healthy control

Eligibility Criteria

• Age: 65 Years - 90 Years
• Sex: all
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study shall involve approximately 30-50 participants (approximately equal number of males and females, equal number with BMI \< and \> 35) meeting inclusion and exclusion criteria.

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

Sponsors & Collaborators

• TriVirum, Inc.: lead

Study Sites (1)

Clayton Sleep Institute

St Louis, Missouri, 63123, United States

Location

MeSH Terms

Conditions

Atrial Fibrillation; Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2022
• First Posted: March 24, 2022
• Study Start: May 12, 2022
• Primary Completion: August 25, 2023
• Study Completion: August 25, 2023
• Last Updated: September 28, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)