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

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

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.

Study Overview

• Status: Completed
• Conditions: Atrial Fibrillation; Catheter Ablation
• Intervention / Treatment: Device: CDS box connection of the Niobe™ Remote Magnetic Navigation System

• Study Type: Observational
• Enrollment (Actual): 30

Contacts and Locations

Study Locations

• Netherlands
  • Zuid Holland
    • Rotterdam, Zuid Holland, Netherlands, 3015CE
      • Erasmus MC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Consecutive participant sampling of patients who will receive RF ablation of cardiac arrhythmias with the Niobe Remote Magnetic Navigation system.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mapping quality	Physician's and technician's subjective score of the quality of mapping the right atrium without CDS box connected and with CDS box connected	One day - during ablation procedure
Pacing thresholds	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	One day - during ablation procedure
Pacing capture	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	One day - during ablation procedure
Electrocardiograms	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	10 months - ECGs will be evaluated after inclusion is completed

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of procedure related major adverse events, attributed to the CDS system	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	30 days
Number of procedure related minor adverse events, attributed to the CDS system	Minor adverse events: post procedural precordial pain, phrenic nerve injury, minor bleeding - type II	30 days
Number of acute procedure succes	Number of procedures with successful electrical isolation of ablated area	1 day - during ablation procedure

Collaborators and Investigators

• Sponsor: Erasmus Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2017
• Primary Completion (Actual): November 8, 2017
• Study Completion (Actual): November 23, 2017

Study Registration Dates

• First Submitted: March 26, 2017
• First Submitted That Met QC Criteria: March 31, 2017
• First Posted (Actual): April 7, 2017

Study Record Updates

• Last Update Posted (Actual): November 27, 2017
• Last Update Submitted That Met QC Criteria: November 23, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Keywords: Atrial Fibrillation; Electrophysiology; Arrhythmias, Cardiac; Atrial Arrhythmia; Cardiac Diseases; Electrophysiologic Techniques, Cardiac; Remote Magnetic Navigation; Contact Detection System
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: CLIN-022

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No