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

NCT03103945 | Completed

• 1 other identifier: CLIN-022
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation; Catheter Ablation

Keywords

Atrial Fibrillation; Atrial Arrhythmia; Arrhythmias, Cardiac; Cardiac Diseases; Electrophysiologic Techniques, Cardiac; Electrophysiology; Remote Magnetic Navigation; Contact Detection System

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (3)

• Number of procedure related major adverse events, attributed to the CDS system

  30 days

• Number of procedure related minor adverse events, attributed to the CDS system

  30 days

• Number of acute procedure succes

  1 day - during ablation procedure

Study Arms (1)

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

Interventions

CDS box connection of the Niobe™ Remote Magnetic Navigation System DEVICE

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.

Patients with cardiac arrhythmias undergoing RF ablation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Erasmus Medical Center: lead

Study Sites (1)

Erasmus MC

Rotterdam, South Holland, 3015CE, Netherlands

Location

MeSH Terms

Conditions

Atrial Fibrillation; Arrhythmias, Cardiac; Heart Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: March 26, 2017
• First Posted: April 7, 2017
• Study Start: April 1, 2017
• Primary Completion: November 8, 2017
• Study Completion: November 23, 2017
• Last Updated: November 27, 2017

Record last verified: 2017-11

Locations

NL (1)