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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2007 by Rigshospitalet, Denmark.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT00524602
First received: August 31, 2007
Last updated: August 10, 2011
Last verified: August 2007
  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

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

Resource links provided by NLM:


Further study details as provided by Rigshospitalet, Denmark:

Primary Outcome Measures:
  • Clinical effect and safety of ablation [ Time Frame: 3 month after procedure ] [ Designated as safety issue: Yes ]
    Stroke and death


Secondary Outcome Measures:
  • Feasibility of remote navigation [ Time Frame: within 3 months ] [ Designated as safety issue: No ]
    Succesrate


Estimated Enrollment: 2000
Study Start Date: June 2007
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: Catheter ablation using the Stereotaxis equipment
    Energy delivery through ablation catheter during an interventional catheterisation of the heart.
    Other Name: Radiofrequency ablation
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

Responsible Party: Jesper Hastrup Svendsen, Rigshospitalet
ClinicalTrials.gov Identifier: NCT00524602     History of Changes
Other Study ID Numbers: STEREOTAXIS study, No funding
Study First Received: August 31, 2007
Last Updated: August 10, 2011
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics

Keywords provided by Rigshospitalet, Denmark:
Stereotaxis
Arrythmia
Catheter ablation
Heart

Additional relevant MeSH terms:
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on August 26, 2014