The Use of Remote Magnetic Navigation in Catheter Ablation of Heart Arrythmia
Recruitment status was Recruiting
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 Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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|
- Clinical effect and safety of ablation [ Time Frame: 3 month after procedure ] [ Designated as safety issue: Yes ]Stroke and death
- Feasibility of remote navigation [ Time Frame: within 3 months ] [ Designated as safety issue: No ]Succesrate
|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)|
Procedure: Catheter ablation using the Stereotaxis equipment
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)
Please refer to this study by its ClinicalTrials.gov identifier: NCT00524602
|Contact: Xu Chen, MD||(+45) 3545 firstname.lastname@example.org|
|Contact: Steen Pehrson, MD||(+45) 3545 email@example.com|
|Copenhagen, Denmark, DK-2100|
|Contact: Jesper H Svendsen, MD (+45) 3545 2817 firstname.lastname@example.org|
|Principal Investigator:||Xu Chen, MD||Rigshospitalet, Denmark|