A Further Study of the Clinical Performance of AFGen1
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- TriVirum, Inc.
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Qualitative Evaluation
Study Overview
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 identify episodes of Afib. The purpose of this study is to establish further evidence for the clinical performance of AFGen1 on human participants.
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 be evaluated by comparing the ECG data acquired by AFGen1 to that acquired by an FDA cleared 12-lead ECG device using a Bland-Altman analysis of the R-R intervals and R amplitude measurements and Eigenvector magnitudes derived from principal component analyses of simultaneously captured waveforms measured by both devices by both devices. The ECG waveforms from both devices will also be adjudicated by 2 independent cardiologists. The study will also seek to demonstrate that there is no degradation in the quality of the ECG signal it acquires when the device is placed in an anticipated misplacement position to that directed by the instructions for use of the device. Finally the study will seek to confirm the adhesive performance of the device is appropriate to support its intended use per the requirements of sections 4.4 and 5.4 of ANSI AAMI EC12-1 . Another purpose of the study is to collect extended 5 minute ECG recordings by the subject periodically triggering the device while wearing the device for 7 (+3) days. This data will be used for product development purposes.
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 90 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •18+ willing to sign the consent form
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Qualitative Evaluation
Time Frame: 1 day
For the qualitative equivalence evaluation according to the two cardiologists confirmation of equivalence must be greater than 95%.
Adhesive performance
Time Frame: 7 to 10 days
The overall average wear time for the device must be greater than 7-days.
Bland-Altman Comparison
Time Frame: 1 day
The waveform characteristics for both the 7- day wear and misplacement elements of this study, the limits of agreement (LoA) from the Bland-Altman analyses shall not exceed the the maximum allowed clinically significant difference between methods i.e. 80ms for R-R. 0.2 mV for R-peak amplitude) for 95% of the subjects on a per-subject basis.
Secondary Outcomes
No secondary outcomes reported