Viewing Study NCT00524602



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Study NCT ID: NCT00524602
Status: UNKNOWN
Last Update Posted: 2011-08-11
First Post: 2007-08-31

Brief Title: The Use of Remote Magnetic Navigation in Catheter Ablation of Heart Arrythmia
Sponsor: Rigshospitalet Denmark
Organization: Rigshospitalet Denmark

Study Overview

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
Status: UNKNOWN
Status Verified Date: 2007-08
Last Known Status: RECRUITING
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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 navigationStereotaxis
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 Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
No funding None None None