The Use of Remote Magnetic Navigation in Catheter Ablation of Heart Arrythmia
|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.|
|ClinicalTrials.gov Identifier: NCT00524602|
Recruitment Status : Unknown
Verified August 2007 by Rigshospitalet, Denmark.
Recruitment status was: Recruiting
First Posted : September 3, 2007
Last Update Posted : August 11, 2011
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 or disease||Intervention/treatment|
|Arrythmia||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)
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||2000 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||June 2007|
|Estimated Primary Completion Date :||June 2012|
|Estimated Study Completion Date :||June 2013|
Procedure: Catheter ablation using the Stereotaxis equipment
- Clinical effect and safety of ablation [ Time Frame: 3 month after procedure ]Stroke and death
- Feasibility of remote navigation [ Time Frame: within 3 months ]Succesrate
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 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|