Further Study of AFGen1 Clinical Performance (CS3)

TriVirum

Status: Completed

Conditions: ECG; Afib; Atrial Fibrillation

Treatments: Device: Periodic ECG triggered measurement; Device: ECG co-measurement

Study type: Observational

Funder types: Industry

Identifiers

NCT06335498

130-0008P

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

20 participants in 2 patient groups

Wear AFGen1 for at least 7 days

Description:

Wear AFGen1 for 7 to 10 days. ECG co-measurement with 12 lead device at start and periodic measurements of ECG with AFGen1 during wear period

Treatment:

Device: ECG co-measurement

Device: Periodic ECG triggered measurement

Misplacement Study Group

Description:

Wear AFGen1 device in misplaced position compared to wearing device in standard position as directed by instructions for use

Treatment:

Device: ECG co-measurement