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

CathVision ApS27 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Cardiac Arrhythmia

Interventions

Electrophysiology procedureDEVICE

Electrophysiology testing and cardiac ablation of arrhythmia

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

The University of vermont

Burlington, Vermont, United States

Outcomes

Primary Outcomes

Baseline Noise Comparison

Measure the peak to peak baseline noise in two EP recording systems for both bipolar and unipolar electrograms in μV

Time frame: EP and ablation procedures can take up to six hours

Freedom From Major Adverse Events, Evaluated at Hospital Discharge

Freedom from major adverse events, evaluated at hospital discharge Adverse events were categorized as one of: An adverse event (AE) A serious adverse event (SAE) An Adverse device effect (ADE) is an AE related to the use of an investigational medical device. A Serious adverse device effect (SADE) is an ADE that that has resulted in any of the consequences characteristic of an SAE. An unanticipated adverse device effect (UADE) is defined as any serious adverse effect on health, safety, any life-threatening problem, death caused by or associated with, a device, if that effect, problem, or death was not previously identified in nature, severity, or degree of incidence in predicate devices, or any other unanticipated serious problem associated with a device that relates to the rights, safety, or welfare of subjects.

Time frame: From EP procedure to discharge is usually one day.

Data from ClinicalTrials.gov

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