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

CathVision

Status: Completed

Conditions: Cardiac Arrhythmia

Treatments: Procedure: EP Procedure

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT05114382

CP-00003

Details and patient eligibility

About

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.

Full 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.

Enrollment: 24 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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24 participants in 1 patient group

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

Other group

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.

Treatment:

Procedure: EP Procedure