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

Study Overview
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Brief Summary
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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.

Detailed Description
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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)

Official Title
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A Nonrandomized Observertionel Study That Will Show the Utility and the Safety by Using the Remote Magnetic Navigation of Ablationcatheters and the Stereotaxis Equipment

Conditions
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Arrythmia

Intervention / Treatment
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* Procedure: Catheter ablation using the Stereotaxis equipment


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Catheter ablation using the Stereotaxis equipment|Energy delivery through ablation catheter during an interventional catheterisation of the heart.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical effect and safety of ablation | Stroke and death | 3 month after procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of remote navigation | Succesrate | within 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stereotaxis, Arrythmia, Catheter ablation, Heart