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The Use of Remote Magnetic Navigation in Catheter Ablation of Heart Arrythmia

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2007 by Rigshospitalet, Denmark.
Recruitment status was:  Recruiting
ClinicalTrials.gov Identifier:
First Posted: September 3, 2007
Last Update Posted: August 11, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Rigshospitalet, Denmark

Patients with several heart arrythmia can potentially be cured by catheterablation. For some arrythmias 95% of the patients are cured. Also patients with atrial fibrillation are cured by catherablation even though the effect is not as impressive as for other cardiac arrythmias. About 70% of patients with paroxystic and persistant atrial fibrillation are cured. Most of the remaining obtain a reduction of their symptoms.

At conventional ablation of atrial fibrillation the catheters are manually navigated to the ideal anatomic position where to isolate the pulmonary veins from the left atrium.

Lately it has been possible to navigate the ablationcatheters using 'remote magnetic navigation' using a magnetic based navigation equipment, Stereotaxis.

The Heartcentre of Rigshospitalet had this Stereotaxis equipment installed in the autumn of 2006.

We will investigate the utility and safety of using this remote magnetic navigation/Stereotaxis.

Condition Intervention
Arrythmia Procedure: Catheter ablation using the Stereotaxis equipment

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Nonrandomized Observertionel Study That Will Show the Utility and the Safety by Using the Remote Magnetic Navigation of Ablationcatheters and the Stereotaxis Equipment

Further study details as provided by Rigshospitalet, Denmark:

Primary Outcome Measures:
  • Clinical effect and safety of ablation [ Time Frame: 3 month after procedure ]
    Stroke and death

Secondary Outcome Measures:
  • Feasibility of remote navigation [ Time Frame: within 3 months ]

Estimated Enrollment: 2000
Study Start Date: June 2007
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: Catheter ablation using the Stereotaxis equipment
    Energy delivery through ablation catheter during an interventional catheterisation of the heart.
    Other Name: Radiofrequency ablation
Detailed Description:

The purpose on this study is to show the utility and the safety by using the remote magnetic navigation of ablation catheters with the Stereotaxis equipment at ablations of

  • atrial fibrillation, atrial flutter and other arrythmias
  • childrens arrythmias
  • arrythmias of patients with pacemaker or ICD (Implantable Cardiac Defibrillator)

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:following patients that need catheter ablation:

  • Patients with atrial fibrillation
  • Patients with artial flutter
  • Patients with other tachy arrythmia
  • Patients with paceaker/ICD

Exclusion Criteria:

  • Patients with anamnestic psycosis or other conditions where information is impossible or insure to give
  • Contraindication to magnetic ablation therapy
  Contacts and Locations
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): NCT00524602

Contact: Xu Chen, MD (+45) 3545 2817 xu.chen@rh.hosp.dk
Contact: Steen Pehrson, MD (+45) 3545 2817 steen.pehrson@rh.hosp.dk

Rigshospitalet Recruiting
Copenhagen, Denmark, DK-2100
Contact: Jesper H Svendsen, MD    (+45) 3545 2817    hastrup@rh.dk   
Sponsors and Collaborators
Rigshospitalet, Denmark
Principal Investigator: Xu Chen, MD Rigshospitalet, Denmark
  More Information

Responsible Party: Jesper Hastrup Svendsen, Rigshospitalet
ClinicalTrials.gov Identifier: NCT00524602     History of Changes
Other Study ID Numbers: STEREOTAXIS study
No funding
First Submitted: August 31, 2007
First Posted: September 3, 2007
Last Update Posted: August 11, 2011
Last Verified: August 2007

Keywords provided by Rigshospitalet, Denmark:
Catheter ablation