The Use of Remote Magnetic Navigation in Catheter Ablation of Heart Arrythmia

NCT ID: NCT00524602

Last Updated: 2011-08-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 2000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-06-30
• Study Completion Date: 2013-06-30

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 navigation/Stereotaxis.

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)

Conditions

Arrythmia

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Catheter ablation using the Stereotaxis equipment

Energy delivery through ablation catheter during an interventional catheterisation of the heart.

Intervention Type: PROCEDURE

Other Intervention Names

Radiofrequency ablation

Eligibility Criteria

Inclusion Criteria

• 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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rigshospitalet, Denmark

OTHER

Sponsor Role: lead

Responsible Party

Rigshospitalet

Principal Investigators

Xu Chen, MD

Role: PRINCIPAL_INVESTIGATOR

Rigshospitalet, Denmark

Locations

Rigshospitalet

Copenhagen, , Denmark

Site Status: RECRUITING

Countries

Denmark

Central Contacts

Xu Chen, MD

Role: CONTACT

xu.chen@rh.hosp.dk

(+45) 3545 2817

Steen Pehrson, MD

Role: CONTACT

steen.pehrson@rh.hosp.dk

(+45) 3545 2817

Facility Contacts

Jesper H Svendsen, MD

Role: primary

hastrup@rh.dk

(+45) 3545 2817

Other Identifiers

No funding

Identifier Type: -

Identifier Source: secondary_id

STEREOTAXIS study

Identifier Type: -

Identifier Source: org_study_id