Prospective Physician-Initiated Observational Study of The Contact Detection System (CDS) in Patients Undergoing Radiofrequency Ablation Using the Niobe™ Remote Magnetic Navigation System
NCT ID: NCT03103945
Last Updated: 2017-11-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
30 participants
OBSERVATIONAL
2017-04-01
2017-11-23
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Patients with cardiac arrhythmias undergoing RF ablation
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.
CDS 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.
Interventions
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CDS 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.
Eligibility Criteria
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Inclusion Criteria
* patients referred to one of the participating ablation centers
* written informed consent
Exclusion Criteria
* contra-indication for general anesthesia
* age below 18 years
18 Years
ALL
No
Sponsors
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Erasmus Medical Center
OTHER
Responsible Party
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Anne-Marie Noten
MD
Locations
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Erasmus MC
Rotterdam, South Holland, Netherlands
Countries
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Other Identifiers
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CLIN-022
Identifier Type: -
Identifier Source: org_study_id