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

NCT00875914 — Phase 4, Completed, 300 participants, Deutsches Herzzentrum Muenchen

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

RegistryNCT00875914, acronym MAGMA-AVNRT
StatusCompleted
PhasePhase 4
Study typeInterventional; randomized, parallel, masking: none, treatment
Enrollment300 (Estimated)
SponsorDeutsches Herzzentrum Muenchen (Other); collaborators: University of Bergen
ConditionsAtrioventricular Nodal Reentry Tachycardia, Radiofrequency Ablation
InterventionsRF-ablation (Procedure)
Datesstart 2009-04-01, primary completion 2012-03-01, completion 2012-10-01, first posted 2009-04-06, last updated 2016-06-27
Locations1 site in Norway

Related Papers Related Patents Related Grants Related Experts
All trials for Atrioventricular Nodal Reentry Tachycardia All trials for Radiofrequency Ablation All trials of RF-ablation

-Summary

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.

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+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.

+Arms and interventions

ArmTypeInterventionsDescription
Manually guidedExperimentalProcedure: RF-ablationTreatment with manually guided RF-catheter
Magnetically navigatedExperimentalProcedure: RF-ablationTreatment with magnetically navigated RF-catheter.
  • RF-ablation (Procedure): 4mm-tip catheter manually guided vs magneticallly navigated

+Outcome measures

Primary outcomes

  • Total x-ray time and dose for patient [electrophysiological examination]

Secondary outcomes

  • 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]

+Eligibility

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

+Locations (1)

FacilityCityCountryStatus
University Hospital BergenBergenNorway

+Investigators