NCT06076798Completed
Clinical Performance of AFGen1
Clinical Performance of the AFGen1 Device Over a 7-day Period
Source: ClinicalTrials.gov · Last updated 11 Apr 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 15 (actual)
- First submitted
- 4 Oct 2023
- Start date
- 5 Oct 2023
- Primary completion date
- 5 Nov 2023
- Lead sponsor
- TriVirum, Inc.
- Diseases
- Atrial fibrillation
- NCT number
- NCT06076798
What you commit to
- Study type: Observational
- Participants enrolled: 15
- From 5 Oct 2023 to the primary completion date, 5 Nov 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Implanted cardiac resynchronization devices
- Physical or mental health conditions that would prevent the person from being able to follow instructions regarding participation in the study
Other
- Implanted pacemakers
- Implanted cardioverter defibrillators
- Potential life-threatening arrythmias
- Open wounds, abraded or irritated skin at the application site
- Planned to undergo a MRI during the course of the study duration
- Known or suspected to be pregnant
- Student or employee of TriVirum
Who the study is looking for
- 1\. 18+ willing to sign the consent form
Age in the registry: 18 years to 90 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| 4927 Lillian Street Coordinator of this site? Confirm its status | San Diego | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.