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NCT Number: NCT03103945

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

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.

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Catheter Ablation Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Erasmus MC

Rotterdam, South Holland, 3015CE, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Mapping quality

    Time frame: 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

  2. Pacing thresholds

    Time frame: 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

  3. Pacing capture

    Time frame: 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

  4. Electrocardiograms

    Time frame: 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

Secondary outcomes

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

    Time frame: 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

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

    Time frame: 30 days

    Minor adverse events: post procedural precordial pain, phrenic nerve injury, minor bleeding - type II

  3. Number of acute procedure succes

    Time frame: 1 day - during ablation procedure

    Number of procedures with successful electrical isolation of ablated area

Sponsors and collaborators

Lead sponsor

Erasmus Medical Center

Other

Registry information

Official study title

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

Acronym: STAR

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Apr 7, 2017
Registry last updated
Nov 27, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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