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

CathVision ApS24 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Cardiac Arrhythmia

Interventions

EP ProcedurePROCEDURE

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patient indicated by investigator for catheter ablation or diagnostic electrophysiology procedure. * Male or non-pregnant female aged ≥18 years. Female patients of childbearing potential must have a negative pregnancy test (per site standard test) within 7 days prior to index procedure. * Able and willing to directly provide informed consent. Exclusion Criteria: * Patient inability to understand or refusal to sign informed consent. * Pregnant or nursing patients and those who plan pregnancy in the period up to 1 month following the index procedure. * Current participation in another investigational drug or device study that interferes with this study. * Patient is a prisoner. * Patients who in the opinion of the physician are not candidates for this study. Prior atrial septal defect (ASD) or patent foramen ovale (PFO) closure with a device using a transcatheter percutaneous approach.

Locations (2)

IKEM, Institue of Clinical and Experimental Medicine

Prague, Czechia

Rigshospitalet

Copenhagen, Denmark

Outcomes

Primary Outcomes

Freedom from major adverse events, evaluated at hospital discharge.

Freedom from major adverse events, evaluated at hospital discharge

Time frame: From EP procedure to hospital discharge is 1 day

Recording low-voltage electrograms

Recording low-voltage electrograms under 20uV amplitude

Time frame: Duration of the EP procedure can take up to 6 hours

The Primary Performance endpoint of study will be evaluated as technical success of CathVision Cube® system to collect and record intracardiac signals during EP procedures

Logging time for arrhythmia termination / block

Time frame: Duration of the EP procedure can take up to 6 hours

Compatibility of Cube System with commercially available 3D mapping system

Assessing compatibility of Cube System with commercially available 3D mapping system with available intracardiac catheters. Compatibility is assessed by that the Cube System does not introduce a visual detectable distortion on the commercial available 3D mapping systems

Time frame: Duration of the EP procedure can take up to 6 hours

Data from ClinicalTrials.gov

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