Clinical Performance of AFGen1

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: NCT06076798
• Other study ID #: 130-0006P
• Status: Completed
• Start date: October 5, 2023
• Est. completion date: November 24, 2023

Study information

• Verified date: April 2024
• 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 AFGen1 on human participants.

Description:

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 .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: November 24, 2023
• Est. primary completion date: November 5, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 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 instructions 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

8. Known or suspected to be pregnant

9. Student or employee of TriVirum

Related Conditions & MeSH terms

• Afib
• Atrial Fibrillation
• ECG

Intervention

Device:
• ECG co-measurement
Measure ECG with 12 lead device at same time that AFGen1 is monitoring ECG

Locations

Country	Name	City	State
United States	4927 Lillian Street	San Diego	California

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 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
Primary	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