Status:
COMPLETED
Clinical Performance of the AFGen1 Device Over a 7-day Period
Lead Sponsor:
TriVirum, Inc.
Conditions:
Atrial Fibrillation
Afib
Eligibility:
All Genders
65-90 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 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.
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 instruc-tions 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
Key Trial Info
Start Date :
May 12 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 25 2023
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT05295056
Start Date
May 12 2022
End Date
August 25 2023
Last Update
September 28 2023
Active Locations (1)
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1
Clayton Sleep Institute
St Louis, Missouri, United States, 63123