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

NCT05114382 | Completed

• 1 other identifier: CP-00003
• Study Type: interventional
• Target: 24
• Locations: 2 countries
• Sites: 2

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.

Conditions

Cardiac Arrhythmia

Keywords

atrial fibrillation; pulmonary vein isolation; radiofrequency; cryo balloon; ablation; software

Outcome Measures

Primary Outcomes (4)

• 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

• Recording low-voltage electrograms

  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

  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

  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

Study Arms (1)

A prospective, multi-center, open-label, single arm study

OTHER

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

Interventions

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

Also known as: electrophysiology procedure

A prospective, multi-center, open-label, single arm study

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• CathVision ApS: lead
• TRIQ GROUP Wherry & Klaffke GbR: collaborator

Study Sites (2)

IKEM, Institue of Clinical and Experimental Medicine

Prague, 14021 Praha 4, Czechia

Location

Rigshospitalet

Copenhagen, 2100, Denmark

Location

MeSH Terms

Conditions

Arrhythmias, Cardiac; Atrial Fibrillation

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Josef Kautzner, Prof.

  IKEM, Prague, Czech Republic

  PRINCIPAL INVESTIGATOR

• Peter K Jacobsen, MD, DMSc

  Righospitalet, Copenhagen, Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A prospective, single center, open-label, single arm study to evaluate the safety and technical performance of the CathVision Cube® system.

Study Record Dates

• First Submitted: August 16, 2021
• First Posted: November 10, 2021
• Study Start: October 2, 2020
• Primary Completion: July 9, 2021
• Study Completion: August 1, 2021
• Last Updated: February 1, 2022

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1); DK (1)