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Completed

NCT Number: NCT05114382

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

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.

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Key information

Conditions

Cardiac Arrhythmia Arrhythmias, Cardiac Atrial Fibrillation Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

IKEM, Institue of Clinical and Experimental Medicine, Prague, Czechia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

EP Procedure

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

Other names: electrophysiology procedure

Primary outcomes

  1. Freedom from major adverse events, evaluated at hospital discharge.

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

    Freedom from major adverse events, evaluated at hospital discharge

  2. Recording low-voltage electrograms

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

    Recording low-voltage electrograms under 20uV amplitude

  3. 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

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

    Logging time for arrhythmia termination / block

  4. Compatibility of Cube System with commercially available 3D mapping system

    Time frame: 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

Sponsors and collaborators

Lead sponsor

CathVision ApS

Industry

Collaborators

  • TRIQ GROUP Wherry & Klaffke GbR

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Nov 10, 2021
Registry last updated
Feb 1, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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