Atrial Fibrillation, Catheter Ablation
Conditions
Keywords
Atrial Fibrillation, Atrial Arrhythmia, Arrhythmias, Cardiac, Cardiac Diseases, Electrophysiologic Techniques, Cardiac, Electrophysiology, Remote Magnetic Navigation, Contact Detection System
Brief summary
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.
Interventions
DEVICECDS box connection of the Niobe™ Remote Magnetic Navigation System
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.
Sponsors
Erasmus Medical Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mapping quality | One day - during ablation procedure | Physician's and technician's subjective score of the quality of mapping the right atrium without CDS box connected and with CDS box connected |
| Pacing thresholds | One day - during ablation procedure | 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 |
| Pacing capture | One day - during ablation procedure | 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 |
| Electrocardiograms | 10 months - ECGs will be evaluated after inclusion is completed | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of procedure related minor adverse events, attributed to the CDS system | 30 days | Minor adverse events: post procedural precordial pain, phrenic nerve injury, minor bleeding - type II |
| Number of acute procedure succes | 1 day - during ablation procedure | Number of procedures with successful electrical isolation of ablated area |
| Number of procedure related major adverse events, attributed to the CDS system | 30 days | 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 |
Countries
Netherlands
Outcome results
None listed