Randomized Comparison Between Magnetically Navigated vs Manually Guided Radiofrequency in AV-node-reentry-tachycardia
| Registry | NCT00875914, acronym MAGMA-AVNRT |
|---|---|
| Status | Completed |
| Phase | Phase 4 |
| Study type | Interventional; randomized, parallel, masking: none, treatment |
| Enrollment | 300 (Estimated) |
| Sponsor | Deutsches Herzzentrum Muenchen (Other); collaborators: University of Bergen |
| Conditions | Atrioventricular Nodal Reentry Tachycardia, Radiofrequency Ablation |
| Interventions | RF-ablation (Procedure) |
| Dates | start 2009-04-01, primary completion 2012-03-01, completion 2012-10-01, first posted 2009-04-06, last updated 2016-06-27 |
| Locations | 1 site in Norway |
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All trials for Atrioventricular Nodal Reentry Tachycardia All trials for Radiofrequency Ablation All trials of RF-ablation
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.
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Manually guided | Experimental | Procedure: RF-ablation | Treatment with manually guided RF-catheter |
| Magnetically navigated | Experimental | Procedure: RF-ablation | Treatment with magnetically navigated RF-catheter. |
Sex: All, ages: 18 Years to 70 Years
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
| Facility | City | Country | Status |
|---|---|---|---|
| University Hospital Bergen | Bergen | Norway |