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

Erasmus University

Status: Completed

Conditions: Atrial Fibrillation; Catheter Ablation

Treatments: Device: CDS box connection of the Niobe™ Remote Magnetic Navigation System

Study type: Observational

Funder types: Other

Identifiers

NCT03103945

CLIN-022

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

30 participants in 1 patient group

Patients with cardiac arrhythmias undergoing RF ablation

Description:

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.

Treatment:

Device: CDS box connection of the Niobe™ Remote Magnetic Navigation System