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

Primary Purpose

Cardiac Arrhythmia

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
EP Procedure
Sponsored by
CathVision ApS
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Cardiac Arrhythmia focused on measuring atrial fibrillation, pulmonary vein isolation, radiofrequency, cryo balloon, ablation, software

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • IKEM, Institue of Clinical and Experimental Medicine
  • Rigshospitalet

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

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

Arm Description

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.

Outcomes

Primary Outcome Measures

Freedom from major adverse events, evaluated at hospital discharge.
Freedom from major adverse events, evaluated at hospital discharge
Recording low-voltage electrograms
Recording low-voltage electrograms under 20uV amplitude
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
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

Secondary Outcome Measures

Full Information

First Posted
August 16, 2021
Last Updated
January 18, 2022
Sponsor
CathVision ApS
Collaborators
TRIQ GROUP Wherry & Klaffke GbR
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1. Study Identification

Unique Protocol Identification Number
NCT05114382
Brief Title
An Evaluation of the Safety and Performance of the CathVision Cube® System
Official Title
An Evaluation of the Safety and Performance of the CathVision Cube® System
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
October 2, 2020 (Actual)
Primary Completion Date
July 9, 2021 (Actual)
Study Completion Date
August 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CathVision ApS
Collaborators
TRIQ GROUP Wherry & Klaffke GbR

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Arrhythmia
Keywords
atrial fibrillation, pulmonary vein isolation, radiofrequency, cryo balloon, ablation, software

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
A prospective, single center, open-label, single arm study to evaluate the safety and technical performance of the CathVision Cube® system.
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A prospective, multi-center, open-label, single arm study
Arm Type
Other
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
EP Procedure
Other Intervention Name(s)
electrophysiology procedure
Intervention Description
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
Primary Outcome Measure Information:
Title
Freedom from major adverse events, evaluated at hospital discharge.
Description
Freedom from major adverse events, evaluated at hospital discharge
Time Frame
From EP procedure to hospital discharge is 1 day
Title
Recording low-voltage electrograms
Description
Recording low-voltage electrograms under 20uV amplitude
Time Frame
Duration of the EP procedure can take up to 6 hours
Title
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
Description
Logging time for arrhythmia termination / block
Time Frame
Duration of the EP procedure can take up to 6 hours
Title
Compatibility of Cube System with commercially available 3D mapping system
Description
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
Time Frame
Duration of the EP procedure can take up to 6 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Josef Kautzner, Prof.
Organizational Affiliation
IKEM, Prague, Czech Republic
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Peter K Jacobsen, MD, DMSc
Organizational Affiliation
Righospitalet, Copenhagen, Denmark
Official's Role
Principal Investigator
Facility Information:
Facility Name
IKEM, Institue of Clinical and Experimental Medicine
City
Prague
ZIP/Postal Code
14021 Praha 4
Country
Czechia
Facility Name
Rigshospitalet
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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