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CompletedNCT00875914MAGMA-AVNRTUpdated Jun 27, 2016

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

A Phase 4 interventional study of RF-ablation in Atrioventricular Nodal Reentry Tachycardia and Radiofrequency Ablation, sponsored by Deutsches Herzzentrum Muenchen. Completed at 1 site in Norway. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2016-06-27.

Sponsored by Deutsches Herzzentrum Muenchen · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
300
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Atrioventricular Nodal Reentry Tachycardia
  • Radiofrequency Ablation

Keywords

  • AV-node reentry tachycardia
  • radiofrequency ablation
  • magnetic navigation system
03

In context

Tachycardia

623 studies on the registry are indexed under Tachycardia; 81 are open to participants now.

This study's planned enrollment of 300 is above the median of 64 across 379 interventional studies indexed under Tachycardia.

Browse Tachycardia studies →

Lead sponsor

Deutsches Herzzentrum Muenchen is the lead sponsor of 112 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 18 to 70 years old
  • suspected AV-node-reentry-tachycardia
  • written informed consent

Exclusion criteria

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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
300 participants (estimated)

Study arms

  • Experimental
    Manually guided

    Treatment with manually guided RF-catheter

    Procedure: RF-ablation

  • Experimental
    Magnetically navigated

    Treatment with magnetically navigated RF-catheter.

    Procedure: RF-ablation

Interventions

  • ProcedureRF-ablation

    4mm-tip catheter manually guided vs magneticallly navigated

06

What researchers measure

Primary outcomes

  1. Total x-ray time and dose for patient

    Time frame: electrophysiological examination

Secondary outcomes

  1. X-ray time and dose for physician

    Time frame: electrophysiological study

  2. Safety of ablation (AV-Block, perforation)

    Time frame: end of electrophysiological study

  3. short-term and long-term-success

    Time frame: end of procedure and 6 months after procedure

  4. number of RF-application

    Time frame: procedure

  5. Duration of electrophysiological study (ablation included)

    Time frame: procedure

07

Study locations

1 site
  • University Hospital Bergen
    Bergen, 5021, Norway
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 27, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00875914
Lead sponsor
Deutsches Herzzentrum Muenchen
Collaborators
University of Bergen
First posted
Apr 6, 2009
Start date
Apr 2009
Primary completion
Mar 2012
Completion
Oct 2012
Last update
Jun 27, 2016

Study contacts

Gabi Hessling, MD
study chair · Deutsches Herzzentrum München
Peter Schuster, MD
study chair · University of Bergen
Isabel Deisenhofer, MD
study chair · Deutsches Herzzentrum München

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2016. You cannot join it, but the record below documents what was studied.

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