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

January 18, 2022 updated by: CathVision ApS
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czechia
      • Prague, Czechia, 14021 Praha 4
        • IKEM, Institue of Clinical and Experimental Medicine
  • Denmark
      • Copenhagen, Denmark, 2100
        • Rigshospitalet

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: A prospective, multi-center, open-label, single arm study
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.
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
Other Names:
  • electrophysiology procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
From EP procedure to hospital discharge is 1 day
Recording low-voltage electrograms
Time Frame: Duration of the EP procedure can take up to 6 hours
Recording low-voltage electrograms under 20uV amplitude
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
Time Frame: Duration of the EP procedure can take up to 6 hours
Logging time for arrhythmia termination / block
Duration of the EP procedure can take up to 6 hours
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
Duration of the EP procedure can take up to 6 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CathVision ApS

Collaborators

TRIQ GROUP Wherry & Klaffke GbR

Investigators

  • Principal Investigator: Josef Kautzner, Prof., IKEM, Prague, Czech Republic
  • Principal Investigator: Peter K Jacobsen, MD, DMSc, Righospitalet, Copenhagen, Denmark

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 2, 2020

Primary Completion (Actual)

July 9, 2021

Study Completion (Actual)

August 1, 2021

Study Registration Dates

First Submitted

August 16, 2021

First Submitted That Met QC Criteria

November 5, 2021

First Posted (Actual)

November 10, 2021

Study Record Updates

Last Update Posted (Actual)

February 1, 2022

Last Update Submitted That Met QC Criteria

January 18, 2022

Last Verified

November 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CP-00003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cardiac Arrhythmia

Clinical Trials on EP Procedure

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Russia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe