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

Arrythmia Clinical Trial

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 Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00524602
• Other study ID #: STEREOTAXIS study
• Secondary ID: No funding
• Status: Recruiting
• Phase: N/A
• First received: August 31, 2007
• Last updated: August 10, 2011
• Start date: June 2007
• Est. completion date: June 2013

Study information

• Verified date: August 2007
• Source: Rigshospitalet, Denmark
• Contact: Xu Chen, MD
• Phone: (+45) 3545 2817
• Email: xu.chen[@]rh.hosp.dk
• Is FDA regulated: No
• Health authority: Denmark: The Danish National Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: June 2013
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arrythmia

Intervention

Procedure:
• Catheter ablation using the Stereotaxis equipment
Energy delivery through ablation catheter during an interventional catheterisation of the heart.

Locations

Country	Name	City	State
Denmark	Rigshospitalet	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical effect and safety of ablation	Stroke and death	3 month after procedure	Yes
Secondary	Feasibility of remote navigation	Succesrate	within 3 months	No