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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06076798
Other study ID # 130-0006P
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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