NCT03103945

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 30 (actual)
• Sponsor: Erasmus Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Atrial Fibrillation
• Catheter Ablation

Interventions

Type	Name	Description
DEVICE	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.

Timeline

• Start date: 2017-04-01
• Primary completion: 2017-11-08
• Completion: 2017-11-23
• First posted: 2017-04-07
• Last updated: 2017-11-27

Locations

1 site across 1 country: Netherlands