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

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ClinicalTrials.gov Identifier: NCT03103945
Recruitment Status : Completed
First Posted : April 7, 2017
Last Update Posted : November 27, 2017
Sponsor:
Information provided by (Responsible Party):
Anne-Marie Noten, 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.


Condition or disease Intervention/treatment
Atrial Fibrillation Catheter Ablation Device: CDS box connection of the Niobe™ Remote Magnetic Navigation System

Study Type : Observational
Actual Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Official 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)
Actual Study Start Date : April 1, 2017
Actual Primary Completion Date : November 8, 2017
Actual Study Completion Date : November 23, 2017

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03103945


Locations
Netherlands
Erasmus MC
Rotterdam, Zuid Holland, Netherlands, 3015CE
Sponsors and Collaborators
Erasmus Medical Center

Responsible Party: Anne-Marie Noten, MD, Erasmus Medical Center
ClinicalTrials.gov Identifier: NCT03103945     History of Changes
Other Study ID Numbers: CLIN-022
First Posted: April 7, 2017    Key Record Dates
Last Update Posted: November 27, 2017
Last Verified: November 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Anne-Marie Noten, Erasmus Medical Center:
Atrial Fibrillation
Atrial Arrhythmia
Arrhythmias, Cardiac
Cardiac Diseases
Electrophysiologic Techniques, Cardiac
Electrophysiology
Remote Magnetic Navigation
Contact Detection System

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes