Clinical Performance of AFGen1

TriVirum

Status: Completed

Conditions: ECG; Afib; Atrial Fibrillation

Treatments: Device: ECG co-measurement

Study type: Observational

Funder types: Industry

Identifiers

NCT06076798

130-0006P

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 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. 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 .

Enrollment: 15 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

15 participants in 1 patient group

Wear AFGen1

Description:

Wear AFGen1 for 7 days. ECG co-measurement with 12 lead device at start and end of wear period

Treatment:

Device: ECG co-measurement