Clinical trial NCT06335498: Further Study of AFGen1 Clinical Performance
Official title: A Further Study of the Clinical Performance of AFGen1
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Afib
ECG
Keywords: ECG signal quality
Lead sponsor: TriVirum, Inc.
Sponsor class: INDUSTRY
First posted: 2024-03-28
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study shall involve up to twenty (20) participants divided into 2 cohorts. The first study cohort will comprise up to fifteen (15) participants (at least 5 male and 5 female) who will wear the device for 7 days. The second cohort of five (5) participants will participate in the misplacement part of the study

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 further evidence for the clinical performance of AFGen1 on human participants.

Detailed 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 using a Bland-Altman analysis of the R-R intervals and R amplitude measurements and Eigenvector magnitudes derived from principal component analyses of simultaneously captured waveforms measured by both devices by both devices. The ECG waveforms from both devices will also be adjudicated by 2 independent cardiologists. The study will also seek to demonstrate that there is no degradation in the quality of the ECG signal it acquires when the device is placed in an anticipated misplacement position to that directed by the instructions for use of the device. Finally the study will seek 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 . Another purpose of the study is to collect extended 5 minute ECG recordings by the subject periodically triggering the device while wearing the device for 7 (+3) days. This data will be used for product development purposes.

Eligibility criteria: 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

Primary outcomes:
measure: Bland-Altman Comparison
timeFrame: 1 day
measure: Qualitative Evaluation
timeFrame: 1 day
measure: Adhesive performance
timeFrame: 7 to 10 days
Secondary outcomes:
Other outcomes:
Locations:
city: Gig Harbor
country: United States
facility: 1808 49Th St Ct NW
state: Washington
Study officials:
affiliation: Unafilliated
name: Allison Willis, BSN RN
role: PRINCIPAL_INVESTIGATOR
References: