Cardiac ArrhythmiaNCT05114382
An Evaluation of the Safety and Performance of the CathVision Cube® System
A study testing EP Procedure in people with Cardiac Arrhythmia, run by CathVision ApS at 2 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Arrhythmia
- What is being tested?
- EP Procedure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 2 Oct 2020to 1 Aug 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Czechia1 site
IKEM, Institue of Clinical and Experimental Medicine
Prague, 14021 Praha 4
About this study
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.
Read the 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.
- Conditions
- Cardiac Arrhythmia
- Being tested
- EP Procedure
- Keywords
- atrial fibrillation, pulmonary vein isolation, radiofrequency, cryo balloon, ablation, software
- Medical subject headings
- Arrhythmias, Cardiac, Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EP ProcedureProcedure or surgery
Also called electrophysiology 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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: EP Procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Freedom from major adverse events, evaluated at hospital discharge.
Freedom from major adverse events, evaluated at hospital discharge
Measured: From EP procedure to hospital discharge is 1 day
Recording low-voltage electrograms
Recording low-voltage electrograms under 20uV amplitude
Measured: 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
Measured: 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
Measured: Duration of the EP procedure can take up to 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2021
- Study start2 Oct 2020
- Primary completion9 Jul 2021
- Study completion1 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac ArrhythmiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- CathVision ApS
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- TRIQ GROUP Wherry & Klaffke GbR
- Responsible party
- Sponsor
- Investigators
- Josef Kautzner, Prof., Principal investigator, IKEM, Prague, Czech RepublicPeter K Jacobsen, MD, DMSc, Principal investigator, Righospitalet, Copenhagen, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05114382
- Sponsor's protocol ID
- CP-00003
- Status last verified
- Nov 2021
- First submitted
- 16 Aug 2021
- Last updated
- 1 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Evaluation of the Safety and Performance of the CathVision Cube® System
- ClinicalTrials.gov ID
- NCT05114382
- Acronym / sponsor ID
- CP-00003
- Conditions
- Cardiac Arrhythmia
- Keywords
- atrial fibrillation, pulmonary vein isolation, radiofrequency, cryo balloon, ablation, software
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- CathVision ApSIndustry (pharma, biotech, devices)
- Collaborators
- TRIQ GROUP Wherry & Klaffke GbR
- Study start
- 2 Oct 2020 (actual)
- Primary completion
- 9 Jul 2021 (actual)
- Study completion
- 1 Aug 2021 (actual)
- First posted
- 10 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A prospective, single center, open-label, single arm study to evaluate the safety and technical performance of the CathVision Cube® system.
| Arm | Type | Receives |
|---|---|---|
| A prospective, multi-center, open-label, single arm study | Other | Procedure: EP ProcedurePatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EP ProcedureAlso: electrophysiology procedureIntracardiac signals will be passively recorded using CathVision Cube® System in parallel with the commercial (CE marked) EP recording system during a scheduled electrophysiology procedure | Procedure or surgery | A prospective, multi-center, open-label, single arm study |
Primary outcome
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
Recording low-voltage electrograms
Time frame: Duration of the EP procedure can take up to 6 hours
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
Time frame: Duration of the EP procedure can take up to 6 hours
Logging time for arrhythmia termination / block
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2022.
- Individual participant dataSharing planned: No
Related trials for Cardiac Arrhythmia
RecruitingObservational study
AI-powered ECG Analysis Using Willem™ Software in High-risk Cardiac Patients (WILLEM)
Cardiomyopathies, Cardiac Arrest
Not yet recruiting
nCPAP-NAVA-Backup Versus Standard nCPAP for Severe Apnea in Preterm Infants ≤28 Weeks
Apnea of Prematurity
Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Enrolling by invitation
VINTAGE (Ventricular Intramyocardial Navigation for Tachycardia Ablation Guided by Electrograms) Using Commercial Off-The-Shelf (COTS) Catheters
Ventricular Arrhythmia
Enrolling by invitation
EDEN Intracardiac Electrogram Recording and Classifying System
Ventricular Arrhythmia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Josef Kautzner, Prof. principal investigator
IKEM, Prague, Czech Republic
Peter K Jacobsen, MD, DMSc principal investigator
Righospitalet, Copenhagen, Denmark
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EP Procedure in people with Cardiac Arrhythmia, run by CathVision ApS at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Czechia, Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Freedom from major adverse events, evaluated at hospital discharge. (time frame: From EP procedure to hospital discharge is 1 day). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2022.