Prospective Physician-Initiated Observational Study of The Contact Detection System (CDS) in Patients Undergoing Radiofrequency Ablation Using the Niobe™ Remote Magnetic Navigation System

Study Overview
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Brief Summary
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This observational study evaluates peri-procedural results of the Niobe™ Remote Magnetic Navigation (RMN) ES system using the contact detection system (CDS) in patients undergoing standard of care radiofrequency ablation of cardiac arrhythmias. The objective of this observational study is to confirm system performance of the CDS and that it does not alter pacing, electrocardiograms, or mapping during RF ablation procedures.

Official Title
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Prospective Physician-Initiated Observational Study of The Contact Detection System (CDS) in Patients Undergoing Radiofrequency Ablation Using the Niobe™ Remote Magnetic Navigation System (STAR)

Conditions
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Atrial Fibrillation, Catheter Ablation

Intervention / Treatment
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* Device: CDS box connection of the Niobe™ Remote Magnetic Navigation System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients with a clinical indication for RF ablation of cardiac arrhythmias with the Niobe Remote Magnetic Navigation system patients referred to one of the participating ablation centers written informed consent Exclusion Criteria: presence of a atrial thrombus or left atrial appendage (LAA) thrombus seen on (contrast) echocardiography or MRI contra-indication for general anesthesia age below 18 years

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with cardiac arrhythmias undergoing RF ablation<br>Patients with cardiac arrhythmias will be undergoing RF ablation using the Niobe Remote Magnetic Navigation System with CDS as their standard of care. System performance data will only be collected during the RF ablation procedure. Outcome measures will be evaluated with the CDS connected and without the CDS connected within all patients. | Device: CDS box connection of the Niobe™ Remote Magnetic Navigation System<br>* For all subjects included in the study, the ablation procedure will be started per standard of care. First mapping, pacing and electrocardiograms of the right atrium will be evaluated without the CDS box connected. Second the CDS box will be connected to the catheter and mapping, pacing and electrocardiograms will be recorded again. Next, ablation will be conducted per standard of care.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mapping quality | Physician's and technician's subjective score of the quality of mapping the right atrium without CDS box connected and with CDS box connected | One day - during ablation procedure | 
| Pacing thresholds | Pacing thresholds of three separate areas of the right atrium without CDS box connected and pacing thresholds of the same three areas with CDS box connected | One day - during ablation procedure | 
| Pacing capture | Pacing capture of three separate areas of the right atrium without CDS box connected and pacing capture of the same three areas with CDS box connected | One day - during ablation procedure | 
| Electrocardiograms | Difference between and disturbance of the intracardiac electrocardiograms without the CDS box connected versus with the CDS box connected, evaluated by two independent and blinded electrophysiologists | 10 months - ECGs will be evaluated after inclusion is completed | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of procedure related major adverse events, attributed to the CDS system | Major adverse events: death, acute myocardial infarction (AMI) or coronary artery damage, major bleeding - type III and V, abdominal bleeding, tamponade > 80cm3, late tamponade, ischemic cerebral event | 30 days | 
| Number of procedure related minor adverse events, attributed to the CDS system | Minor adverse events: post procedural precordial pain, phrenic nerve injury, minor bleeding - type II | 30 days | 
| Number of acute procedure succes | Number of procedures with successful electrical isolation of ablated area | 1 day - during ablation procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Electrophysiology, Remote Magnetic Navigation, Contact Detection System, Atrial Fibrillation, Atrial Arrhythmia, Arrhythmias, Cardiac, Cardiac Diseases, Electrophysiologic Techniques, Cardiac