Clinical trial NCT05114382: 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
Overall status: COMPLETED
Phase: NA
Conditions: Cardiac Arrhythmia
Keywords: atrial fibrillation
pulmonary vein isolation
radiofrequency
cryo balloon
ablation
software
Lead sponsor: CathVision ApS
Sponsor class: INDUSTRY
Collaborators: name: TRIQ GROUP Wherry & Klaffke GbR
First posted: 2021-11-10
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: A prospective, single center, open-label, single arm study to evaluate the safety and technical performance of the CathVision Cube® system.
Primary purpose: DIAGNOSTIC

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.

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.

Primary outcomes:
measure: Freedom from major adverse events, evaluated at hospital discharge.
timeFrame: From EP procedure to hospital discharge is 1 day
measure: Recording low-voltage electrograms
timeFrame: Duration of the EP procedure can take up to 6 hours
measure: 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
timeFrame: Duration of the EP procedure can take up to 6 hours
measure: Compatibility of Cube System with commercially available 3D mapping system
timeFrame: Duration of the EP procedure can take up to 6 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Prague
country: Czechia
facility: IKEM, Institue of Clinical and Experimental Medicine
city: Copenhagen
country: Denmark
facility: Rigshospitalet
Study officials:
affiliation: IKEM, Prague, Czech Republic
name: Josef Kautzner, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Righospitalet, Copenhagen, Denmark
name: Peter K Jacobsen, MD, DMSc
role: PRINCIPAL_INVESTIGATOR
References: