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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Prospective, Single-Center, Open-Label, Single-Arm Study to Evaluate the Safety and Technical Performance of the CathVision ECGenius® System.

Conditions
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Cardiac Arrhythmia

Intervention / Treatment
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* Device: Electrophysiology procedure


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Electrophysiology procedure|Electrophysiology testing and cardiac ablation of arrhythmia|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intracardiac signal collection | Technical success of CathVision ECGenius® system to collect and record intracardiac signals during EP procedures | EP and ablation procedures can take up to six hours | 
| Low voltage electrogram | Ability of CathVision ECGenius to collect low voltage electrograms of less than 20uV in different cardiac rhythms | 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 | From EP procedure to discharge is usually one day. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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electrophysiology, atrial fibrillation, cardiac ablation