Ignite Creation Date:
2025-12-25 @ 4:02 AM
Ignite Modification Date:
2025-12-26 @ 2:56 AM
Study NCT ID:
NCT05477602
Status:
COMPLETED
Last Update Posted:
2025-02-24
First Post:
2022-07-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Automated Calculation of AF Cycle Length and Complexity Using a Novel EP Recording System
Sponsor:
CathVision ApS
Organization:
Study Overview
Official Title:
The Automated Calculation of AF Cycle Length and Complexity Using a Novel EP Recording System (The CathVision ECGenius System)
Status:
COMPLETED
Status Verified Date:
2025-02
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:
Collect electrophysiological data during atrial fibrillation (AF) ablation procedures to assess the performance of a Signal Complexity Visualization algorithm designed to be integrated into the CathVision ECGenius® System.
Detailed Description:
A prospective, single-center, feasibility study using the CathVision ECGenius® system and a Signal Complexity Visualization Algorithm during radiofrequency (RF) ablation procedures to treat persistent AF.
Subjects with persistent AF who are indicated to undergo a routine-practice RF ablation may be enrolled in the Study. Intracardiac signals will be passively recorded using the investigational CathVision ECGenius® System in parallel with a commercial (CE Approved) EP recording system. The investigational device will not be used for direct clinical care decisions or therapy.
The validation of the Signal Complexity Visualization Algorithm will be performed offline and retrospectively.
Subjects with persistent AF who are indicated to undergo a routine-practice RF ablation may be enrolled in the Study. Intracardiac signals will be passively recorded using the investigational CathVision ECGenius® System in parallel with a commercial (CE Approved) EP recording system. The investigational device will not be used for direct clinical care decisions or therapy.
The validation of the Signal Complexity Visualization Algorithm will be performed offline and retrospectively.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: