Magnetically Navigated vs. Manually Guided Radiofrequency in Atrioventricular-node-reentry-tachycardia

Study Overview
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Brief Summary
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The MAGMA-AVNRT study compares two different methods of handling the ablation catheters for av-node-reentry-tachycardia with regard to x-ray dose, safety and success: manually guided vs magnetically navigated RF-catheter.

Detailed Description
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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.

Official Title
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Randomized Comparison Between Magnetically Navigated vs Manually Guided Radiofrequency in AV-node-reentry-tachycardia

Conditions
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Atrioventricular Nodal Reentry Tachycardia, Radiofrequency Ablation

Intervention / Treatment
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* Procedure: RF-ablation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Manually guided<br>Treatment with manually guided RF-catheter | Procedure: RF-ablation<br>* 4mm-tip catheter manually guided vs magneticallly navigated<br>|
| Experimental: Magnetically navigated<br>Treatment with magnetically navigated RF-catheter. | Procedure: RF-ablation<br>* 4mm-tip catheter manually guided vs magneticallly navigated<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total x-ray time and dose for patient |  | electrophysiological examination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| X-ray time and dose for physician |  | electrophysiological study | 
| Safety of ablation (AV-Block, perforation) |  | end of electrophysiological study | 
| short-term and long-term-success |  | end of procedure and 6 months after procedure | 
| number of RF-application |  | procedure | 
| Duration of electrophysiological study (ablation included) |  | procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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AV-node reentry tachycardia, radiofrequency ablation, magnetic navigation system