Ignite Creation Date:
2024-05-06 @ 8:18 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06335498
Status:
COMPLETED
Last Update Posted:
2024-06-20
First Post:
2024-03-21
Brief Title:
Further Study of AFGen1 Clinical Performance
Sponsor:
TriVirum Inc
Organization:
TriVirum Inc
Study Overview
Official Title:
A Further Study of the Clinical Performance of AFGen1
Status:
COMPLETED
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CS3
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 44 and 54 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None