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

Not Applicable

Completed

• Conditions: Cardiac Arrhythmia
• Interventions: Procedure: EP Procedure

• Registration Number: NCT05114382
• Lead Sponsor: CathVision ApS

Brief 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.

Study Timeline

• Study Start: 2020-10-02
• Primary Completion: 2021-07-09
• Study Completion: 2021-08-01
• Study First Submitted: 2021-08-16
• Status Verified: 2021-11
• Study First Submitted QC: 2021-11-05
• Study First Posted: 2021-11-10
• Last Update Submitted: 2022-01-18
• Last Update Posted: 2022-02-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
A prospective, multi-center, open-label, single arm study	EP Procedure	Patients undergoing assessment and ablation of cardiac arrhythmiast. who are scheduled for an electrophysiology (EP) procedure and 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 the commercial (CE marked) EP recording system for post procedure evaluation. 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.

Primary Outcome Measures

Name	Time	Method
Recording low-voltage electrograms	Duration of the EP procedure can take up to 6 hours	Recording low-voltage electrograms under 20uV amplitude
Freedom from major adverse events, evaluated at hospital discharge.	From EP procedure to hospital discharge is 1 day	Freedom from major adverse events, evaluated at hospital discharge
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	Duration of the EP procedure can take up to 6 hours	Logging time for arrhythmia termination / block
Compatibility of Cube System with commercially available 3D mapping system	Duration of the EP procedure can take up to 6 hours	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

Trial Locations

Locations (2)

IKEM, Institue of Clinical and Experimental Medicine; 🇨🇿 Prague, Czechia

Rigshospitalet; 🇩🇰 Copenhagen, Denmark