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

Primary Purpose

Arrythmia

Status
Unknown status
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Catheter ablation using the Stereotaxis equipment
Sponsored by
Rigshospitalet, Denmark
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Arrythmia focused on measuring Stereotaxis, Arrythmia, Catheter ablation, Heart

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • RigshospitaletRecruiting

Outcomes

Primary Outcome Measures

Clinical effect and safety of ablation
Stroke and death

Secondary Outcome Measures

Feasibility of remote navigation
Succesrate

Full Information

First Posted
August 31, 2007
Last Updated
August 10, 2011
Sponsor
Rigshospitalet, Denmark
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1. Study Identification

Unique Protocol Identification Number
NCT00524602
Brief Title
The Use of Remote Magnetic Navigation in Catheter Ablation of Heart Arrythmia
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2007
Overall Recruitment Status
Unknown status
Study Start Date
June 2007 (undefined)
Primary Completion Date
June 2012 (Anticipated)
Study Completion Date
June 2013 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Rigshospitalet, Denmark

4. Oversight

Data Monitoring Committee
No

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arrythmia
Keywords
Stereotaxis, Arrythmia, Catheter ablation, Heart

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
2000 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Catheter ablation using the Stereotaxis equipment
Other Intervention Name(s)
Radiofrequency ablation
Intervention Description
Energy delivery through ablation catheter during an interventional catheterisation of the heart.
Primary Outcome Measure Information:
Title
Clinical effect and safety of ablation
Description
Stroke and death
Time Frame
3 month after procedure
Secondary Outcome Measure Information:
Title
Feasibility of remote navigation
Description
Succesrate
Time Frame
within 3 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xu Chen, MD
Phone
(+45) 3545 2817
Email
xu.chen@rh.hosp.dk
First Name & Middle Initial & Last Name or Official Title & Degree
Steen Pehrson, MD
Phone
(+45) 3545 2817
Email
steen.pehrson@rh.hosp.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xu Chen, MD
Organizational Affiliation
Rigshospitalet, Denmark
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rigshospitalet
City
Copenhagen
ZIP/Postal Code
DK-2100
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jesper H Svendsen, MD
Phone
(+45) 3545 2817
Email
hastrup@rh.dk

12. IPD Sharing Statement

Learn more about this trial

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

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