Clinical Performance of the AFGen1 Device Over a 7-day Period

TriVirum

Status: Completed

Conditions: Paroxysmal Atrial Fibrillation; Afib; Atrial Fibrillation; Arrhythmias Paroxysmal; Irregular Heart Beat; Arrhythmias, Cardiac; Arrhythmia Atrial

Treatments: Device: AFGen 1 Device Single Use; Device: AFGen1 Device Wear Test

Study type: Observational

Funder types: Industry

Identifiers

NCT05295056

AFib-Chek-001

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 the AFib-Chek device (a.k.a. Device) on human participants.

Full description

The primary purpose of this study is to demonstrate that the ECD signal acquired by the AFGen1 device is as of adequate quality and is suitable to support its intended use for the detection of AFib.

Enrollment: 38 patients

Sex: All

Ages: 65 to 90 years old

Volunteers: No 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 instruc-tions 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

Trial design

38 participants in 2 patient groups

Permanent atrial fibrillation

Description:

Known to have permanent atrial fibrillation

Treatment:

Device: AFGen1 Device Wear Test

Healthy control

Description:

Healthy controls

Treatment:

Device: AFGen 1 Device Single Use

Device: AFGen1 Device Wear Test