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.
Study Type
OBSERVATIONAL
Enrollment
30
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.
Erasmus MC
Rotterdam, South Holland, Netherlands
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 10 months - ECGs will be evaluated after inclusion is completed
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
Time frame: 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
Time frame: 30 days
Number of acute procedure succes
Number of procedures with successful electrical isolation of ablated area
Time frame: 1 day - during ablation procedure
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