NCT05477602

The Automated Calculation of AF Cycle Length and Complexity Using a Novel EP Recording System

The Automated Calculation of AF Cycle Length and Complexity Using a Novel EP Recording System (The CathVision ECGenius System)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 21 (actual)
• Sponsor: CathVision ApS · Industry
• Sex: All
• Age: 21 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Atrial Fibrillation

Interventions

Type	Name	Description
PROCEDURE	Cardiac Ablation for the treatment of persistent Atrial Fibrillation	Patients undergoing cardiac ablation for the treatment of persistent atrial fibrillation

Timeline

• Start date: 2023-01-16
• Primary completion: 2024-12-31
• Completion: 2024-12-31
• First posted: 2022-07-28
• Last updated: 2026-01-30
• Results posted: 2026-01-30

Locations

1 site across 1 country: Belgium