An Evaluation of the Safety and Performance of the CathVision ECGenius® System.

CathVision

Status: Completed

Conditions: Cardiac Arrhythmia

Treatments: Device: Electrophysiology procedure

Study type: Observational

Funder types: Industry; Other

Identifiers

NCT05301803

CP-00003-A

Details and patient eligibility

About

The primary objective is to evaluate the safety and technical performance of the CathVision ECGenius® 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 ECGenius® system.

Patients undergoing assessment and ablation of cardiac arrhythmias during an electrophysiology (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 ECGenius® System in parallel with a commercial 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: 27 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient is scheduled for catheter ablation or diagnostic electrophysiology procedure.
• At least 18 years of age.
• Able and willing to provide informed consent or obtain consent from a legally authorized representative (LAR).

Exclusion criteria

• Patient inability to understand or refusal to sign informed consent.
• Patient is a prisoner or under incarceration
• Patients who in the opinion of the physician are not candidates for this study.

Trial design