An observational study in Atrial Fibrillation, Afib and ECG, sponsored by TriVirum, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-06-20.
Sponsored by TriVirum, Inc. · Observational
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.
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.
3,957 studies on the registry are indexed under Atrial Fibrillation; 933 are open to participants now.
This study's enrollment of 20 is below the median of 300 across 1,390 observational studies indexed under Atrial Fibrillation.
Browse Atrial Fibrillation studies →TriVirum, Inc. is the lead sponsor of 3 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
The study shall involve up to twenty (20) participants divided into 2 cohorts. The first study cohort will comprise up to fifteen (15) participants (at least 5 male and 5 female) who will wear the device for 7 days. The second cohort of five (5) participants will participate in the misplacement part of the study
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
1. 18+ willing to sign the consent form
Exclusion Criteria:
Wear AFGen1 for 7 to 10 days. ECG co-measurement with 12 lead device at start and periodic measurements of ECG with AFGen1 during wear period
Device: ECG co-measurement · Device: Periodic ECG triggered measurement
Wear AFGen1 device in misplaced position compared to wearing device in standard position as directed by instructions for use
Device: ECG co-measurement
Measure ECG with 12 lead device at same time that AFGen1 is monitoring ECG
Subject triggers AFGen1 to perform an extended measurement during wear period
Bland-Altman Comparison
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.
Time frame: 1 day
Qualitative Evaluation
For the qualitative equivalence evaluation according to the two cardiologists confirmation of equivalence must be greater than 95%.
Time frame: 1 day
Adhesive performance
The overall average wear time for the device must be greater than 7-days.
Time frame: 7 to 10 days
Plan to share: No
No publications or documents are linked to this record.
Ran from Apr 2024 to primary completion in Apr 2024, 0 months.
Of 149 industry-sponsored observational studies under Atrial Fibrillation, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 44. This study's 0 months is below that.
Counting every sponsor, half of 685 studies reached it within 38 months; a quarter within 22 and three quarters within 75.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.
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TriVirum, Inc.