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Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05477602
Study type Observational
Source CathVision ApS
Contact Tom De Potter, MD
Phone +32 53 724439
Email tomdepotter@gmail.com
Status Recruiting
Phase
Start date January 16, 2023
Completion date December 31, 2024

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