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

Not Applicable

• Conditions: Arrythmia

• Registration Number: NCT00524602
• Lead Sponsor: Rigshospitalet, Denmark

Brief Summary

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

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)

Study Timeline

• Study Start: 2007-06
• Status Verified: 2007-08
• Study First Submitted: 2007-08-31
• Study First Submitted QC: 2007-08-31
• Study First Posted: 2007-09-03
• Last Update Submitted: 2011-08-10
• Last Update Posted: 2011-08-11
• Primary Completion: 2012-06
• Study Completion: 2013-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 2000

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Clinical effect and safety of ablation	3 month after procedure	Stroke and death

Secondary Outcome Measures

Name	Time	Method
Feasibility of remote navigation	within 3 months	Succesrate

Trial Locations

Locations (1)

Rigshospitalet; 🇩🇰 Copenhagen, Denmark