The Use of Remote Magnetic Navigation in Catheter Ablation of Heart Arrythmia
A Nonrandomized Observertionel Study That Will Show the Utility and the Safety by Using the Remote Magnetic Navigation of Ablationcatheters and the Stereotaxis Equipment
2 other identifiers
interventional
2,000
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2007
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2007
CompletedFirst Submitted
Initial submission to the registry
August 31, 2007
CompletedFirst Posted
Study publicly available on registry
September 3, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2013
CompletedAugust 11, 2011
August 1, 2007
5 years
August 31, 2007
August 10, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Clinical effect and safety of ablation
Stroke and death
3 month after procedure
Secondary Outcomes (1)
Feasibility of remote navigation
within 3 months
Interventions
Energy delivery through ablation catheter during an interventional catheterisation of the heart.
Eligibility Criteria
You may qualify if:
- Patients with atrial fibrillation
- Patients with artial flutter
- Patients with other tachy arrythmia
- Patients with paceaker/ICD
You may not qualify if:
- Patients with anamnestic psycosis or other conditions where information is impossible or insure to give
- Contraindication to magnetic ablation therapy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Rigshospitalet
Copenhagen, DK-2100, Denmark
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Xu Chen, MD
Rigshospitalet, Denmark
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
August 31, 2007
First Posted
September 3, 2007
Study Start
June 1, 2007
Primary Completion
June 1, 2012
Study Completion
June 1, 2013
Last Updated
August 11, 2011
Record last verified: 2007-08