The Use of Remote Magnetic Navigation in Catheter Ablation of Heart Arrythmia
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...
Brief Summary
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”
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.
- Study Type: Interventional
- Study Design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
- Study Primary Completion Date: June 2012
Detailed Clinical Trial 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)
Intervention(s) in this Clinical Trial
- Procedure: Catheter ablation using the Stereotaxis equipment
- Energy delivery through ablation catheter during an interventional catheterisation of the heart.
Outcome Measures for this Clinical Trial
Primary Measures
- Clinical effect and safety of ablation
- Time Frame: 3 month after procedure
Safety Issue?: Yes
- Time Frame: 3 month after procedure
Secondary Measures
- Feasibility of remote navigation
- Time Frame: within 3 months
Safety Issue?: No
- Time Frame: within 3 months
Criteria for Participation in this Clinical Trial
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
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: N/A
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Investigator Information
Lead Investigator: Rigshospitalet, Denmark Other
Overall Clinical Trial Officials and Contacts
Xu Chen, MD Principal Investigator Rigshospitalet, Denmark
Overall Contact: Xu Chen, MD (+45) 3545 2817 xu.chen@rh.hosp.dk
Additional Information
Information obtained from ClinicalTrials.gov on February 12, 2012
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00524602
Study ID Number: STEREOTAXIS study
ClinicalTrials.gov Identifier: NCT00524602
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00524602
