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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


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
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