Status:
COMPLETED
Clinical Performance of AFGen1
Lead Sponsor:
TriVirum, Inc.
Conditions:
Atrial Fibrillation
Afib
Eligibility:
All Genders
18-90 years
Brief 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 ident...
Detailed 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...
Eligibility Criteria
Inclusion
- 1\. 18+ willing to sign the consent form
Exclusion
- Implanted pacemakers
- Implanted cardioverter defibrillators
- Implanted cardiac resynchronization devices
- Potential life-threatening arrythmias
- Physical or mental health conditions that would prevent the person from being able to follow instructions regarding participation in the study
- 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
Key Trial Info
Start Date :
October 5 2023
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 24 2023
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT06076798
Start Date
October 5 2023
End Date
November 24 2023
Last Update
April 11 2024
Active Locations (1)
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1
4927 Lillian Street
San Diego, California, United States, 92110