Ignite Creation Date:
2025-12-24 @ 11:36 PM
Ignite Modification Date:
2026-03-06 @ 10:57 AM
Study NCT ID:
NCT05295056
Status:
COMPLETED
Last Update Posted:
2023-09-28
First Post:
2022-03-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Performance of the AFGen1 Device Over a 7-day Period
Sponsor:
TriVirum, Inc.
Organization:
Study Overview
Official Title:
Clinical Performance of the AFGen1 Device Over a 7-day Period
Status:
COMPLETED
Status Verified Date:
2023-09
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:
None
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 the clinical performance of the AFib-Chek device (a.k.a. Device) on human participants.
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.
Study Oversight
Has Oversight DMC:
False
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?: