The Use of Remote Magnetic Navigation in Catheter Ablation of Heart Arrythmia - Full Text View

Sponsored by:	Rigshospitalet, Denmark
Information provided by:	Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:	NCT00524602

Purpose

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	Intervention
Arrythmia	Procedure: Catheter ablation using the Stereotaxis equipment

Genetics Home Reference related topics: Brugada syndrome short QT syndrome

MedlinePlus related topics: Arrhythmia

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
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

Further study details as provided by Rigshospitalet, Denmark:

Primary Outcome Measures:

Clinical effect and safety of ablation [ Time Frame: 3 month after procedure ]

Secondary Outcome Measures:

Feasibility of remote navigation [ Time Frame: within 3 months ]

Estimated Enrollment:	2000
Study Start Date:	June 2007
Estimated Study Completion Date:	June 2012

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)

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00524602

Contacts

Contact: Xu Chen, MD	(+45) 3545 2817 ext -	xu.chen@rh.hosp.dk
Contact: Steen Pehrson, MD	(+45) 3545 2817	steen.pehrson@rh.hosp.dk

Locations

Denmark
Rigshospitalet	Recruiting
Copenhagen, Denmark, DK-2100
Contact: Jesper H Svendsen, MD (+45) 3545 2817 hastrup@rh.dk

Sponsors and Collaborators

Rigshospitalet, Denmark

Investigators

Principal Investigator:

Xu Chen, MD

Rigshospitalet, Denmark

More Information

Study ID Numbers:	STEREOTAXIS study
Study First Received:	August 31, 2007
Last Updated:	August 31, 2007
ClinicalTrials.gov Identifier:	NCT00524602
Health Authority:	Denmark: The Danish National Committee on Biomedical Research Ethics

Keywords provided by Rigshospitalet, Denmark:

Stereotaxis
Arrythmia
Catheter ablation
Heart

Study placed in the following topic categories:

Heart Diseases
Arrhythmias, Cardiac

Additional relevant MeSH terms:

Pathologic Processes
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 14, 2009