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

Atrial Fibrillation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05295056
• Other study ID #: AFib-Chek-001
• Status: Completed
• Start date: May 12, 2022
• Est. completion date: August 25, 2023

Study information

• Verified date: September 2023
• Source: TriVirum, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: August 25, 2023
• Est. primary completion date: August 25, 2023
• Gender: All
• Age group: 65 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Afib
• Arrhythmia Atrial
• Arrhythmias, Cardiac
• Atrial Fibrillation
• Paroxysmal Atrial Fibrillation

Intervention

Device:
• AFGen1 Device Wear Test
Participant wears the device for 7 days
• AFGen 1 Device Single Use
Participant wears the device in conjunction with a standard ECG

Locations

Country	Name	City	State
United States	Clayton Sleep Institute	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
TriVirum, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Qualitative Equivalence Evaluation	For the qualitative equivalence evaluation according to the two cardiologists the confirmation of equivalence must be greater than 95%.	7 days
Primary	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