Trials / Completed
CompletedNCT05295056
Clinical Performance of the AFGen1 Device Over a 7-day Period
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 38 (actual)
- Sponsor
- TriVirum, Inc. · Industry
- Sex
- All
- Age
- 65 Years – 90 Years
- Healthy volunteers
- —
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 the AFib-Chek device (a.k.a. Device) on human participants.
Detailed 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.
Conditions
- Atrial Fibrillation
- Afib
- Irregular Heart Beat
- Arrhythmias, Cardiac
- Arrhythmia Atrial
- Arrhythmias Paroxysmal
- Paroxysmal Atrial Fibrillation
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | AFGen1 Device Wear Test | Participant wears the device for 7 days |
| DEVICE | AFGen 1 Device Single Use | Participant wears the device in conjunction with a standard ECG |
Timeline
- Start date
- 2022-05-12
- Primary completion
- 2023-08-25
- Completion
- 2023-08-25
- First posted
- 2022-03-24
- Last updated
- 2023-09-28
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT05295056. Inclusion in this directory is not an endorsement.