- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00875914
Magnetically Navigated vs. Manually Guided Radiofrequency in Atrioventricular-node-reentry-tachycardia (MAGMA-AVNRT)
Randomized Comparison Between Magnetically Navigated vs Manually Guided Radiofrequency in AV-node-reentry-tachycardia
Study Overview
Status
Intervention / Treatment
Detailed Description
AV-node reentry tachycardia can be treated by radiofrequency ablation or modulation of the slow pathway of the av node. The success rate is 90 to 95%.
There are different options to navigate the ablation catheter: manually guided vs magnetically guided.
For magnetic guidance two magnets are positioned beneath the patient. A mangetic field is induced and a catheter with a ferromagnetic tip can be navigated from outside with a joystick by modifying the vectors of the magnetic field.
We hypothesized that a magnetic guidance of the RF-ablation catheter results in lower x-ray time and dose for the patient and the physician with comparable safety und success rates.
Study Type
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
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Bergen, Norway, 5021
- University Hospital Bergen
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 18 to 70 years old
- suspected AV-node-reentry-tachycardia
- written informed consent
Exclusion Criteria:
- pregnancy
- contraindication against electrophysiological study or ablation
- congenital heart disease or other anatomical abnormalities
- previous surgical procedure involving atrium except aorto-coronary bypass grafts
- psychiatric disease that makes a completion of study improbable
- severe comorbidities with a life expectancy less than 6 months
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Manually guided
Treatment with manually guided RF-catheter
|
4mm-tip catheter manually guided vs magneticallly navigated
|
Experimental: Magnetically navigated
Treatment with magnetically navigated RF-catheter.
|
4mm-tip catheter manually guided vs magneticallly navigated
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Total x-ray time and dose for patient
Time Frame: electrophysiological examination
|
electrophysiological examination
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
X-ray time and dose for physician
Time Frame: electrophysiological study
|
electrophysiological study
|
Safety of ablation (AV-Block, perforation)
Time Frame: end of electrophysiological study
|
end of electrophysiological study
|
short-term and long-term-success
Time Frame: end of procedure and 6 months after procedure
|
end of procedure and 6 months after procedure
|
number of RF-application
Time Frame: procedure
|
procedure
|
Duration of electrophysiological study (ablation included)
Time Frame: procedure
|
procedure
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Gabi Hessling, MD, Deutsches Herzzentrum München
- Study Chair: Peter Schuster, MD, University of Bergen
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GE IDE No. C00909
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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