Cardiac Arrhythmia
Conditions
Keywords
atrial fibrillation, pulmonary vein isolation, radiofrequency, cryo balloon, ablation, software
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.
Interventions
PROCEDUREEP 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
Sponsors
TRIQ GROUP Wherry & Klaffke GbR
CathVision ApS
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
A prospective, single center, open-label, single arm study to evaluate the safety and technical performance of the CathVision Cube® system.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Freedom from major adverse events, evaluated at hospital discharge. | From EP procedure to hospital discharge is 1 day | Freedom from major adverse events, evaluated at hospital discharge |
| Recording low-voltage electrograms | 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 | 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 | 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 |
Countries
Czechia, Denmark
Outcome results
None listed