NCT05114382

An Evaluation of the Safety and Performance of the CathVision Cube® System

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: CathVision ApS · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objective is to evaluate the safety and technical performance of the CathVision Cube® System. The secondary objective is to benchmark the intracardiac electrogram signal quality compared to commercially available systems in patients undergoing assessment and ablation of cardiac arrhythmias.

Detailed description

A prospective, single center, open-label, single arm study to evaluate the safety and technical performance of the CathVision Cube® system. Patients undergoing assessment and ablation of cardiac arrhythmias, by Electro Physiology (EP) procedure, and who meet all inclusion criteria will be enrolled in the study and undergo the EP procedure. Intracardiac signals will be passively recorded using the CathVision Cube® System in parallel with a commercial (CE marked) EP recording system and later compared and evaluated. The investigational device will not be used for direct clinical care decisions or therapy. The EP procedure will be guided by the study site Standards Of Care.

Conditions

• Cardiac Arrhythmia

Interventions

Type	Name	Description
PROCEDURE	EP Procedure	Intracardiac signals will be passively recorded using CathVision Cube® System in parallel with the commercial (CE marked) EP recording system during a scheduled electrophysiology procedure

Timeline

• Start date: 2020-10-02
• Primary completion: 2021-07-09
• Completion: 2021-08-01
• First posted: 2021-11-10
• Last updated: 2022-02-01

Locations

2 sites across 2 countries: Czechia, Denmark