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

Cardiac Arrhythmia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05114382
• Other study ID #: CP-00003
• Status: Completed
• Phase: N/A
• Start date: October 2, 2020
• Est. completion date: August 1, 2021

Study information

• Verified date: November 2021
• Source: CathVision ApS
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: August 1, 2021
• Est. primary completion date: July 9, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Arrhythmias, Cardiac
• Cardiac Arrhythmia

Intervention

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

Locations

Country	Name	City	State
Czechia	IKEM, Institue of Clinical and Experimental Medicine	Prague
Denmark	Rigshospitalet	Copenhagen

Sponsors (2)

Lead Sponsor	Collaborator
CathVision ApS	TRIQ GROUP Wherry & Klaffke GbR

Countries where clinical trial is conducted

Czechia,  Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Freedom from major adverse events, evaluated at hospital discharge.	Freedom from major adverse events, evaluated at hospital discharge	From EP procedure to hospital discharge is 1 day
Primary	Recording low-voltage electrograms	Recording low-voltage electrograms under 20uV amplitude	Duration of the EP procedure can take up to 6 hours
Primary	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	Duration of the EP procedure can take up to 6 hours
Primary	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	Duration of the EP procedure can take up to 6 hours