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

Completed

• Conditions: Atrial Fibrillation; Catheter Ablation
• Interventions: Device: CDS box connection of the Niobe™ Remote Magnetic Navigation System

• Registration Number: NCT03103945
• Lead Sponsor: Erasmus Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-03-26
• Study First Submitted QC: 2017-03-31
• Study Start: 2017-04-01
• Study First Posted: 2017-04-07
• Status Verified: 2017-11
• Primary Completion: 2017-11-08
• Study Completion: 2017-11-23
• Last Update Submitted: 2017-11-23
• Last Update Posted: 2017-11-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with cardiac arrhythmias undergoing RF ablation	CDS box connection of the Niobe™ Remote Magnetic Navigation System	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.

Primary Outcome Measures

Name	Time	Method
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
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

Secondary Outcome Measures

Name	Time	Method
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
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

Trial Locations

Locations (1)

Erasmus MC; 🇳🇱 Rotterdam, Zuid Holland, Netherlands