Skip to main content
OpenTrials
Completed

NCT Number: NCT00875914

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Atrioventricular Nodal Reentry Tachycardia Arrhythmias, Cardiac Cardiac Conduction System Disease Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Radiofrequency Ablation Tachycardia Tachycardia, Atrioventricular Nodal Reentry Tachycardia, Reciprocating

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University Hospital Bergen

Bergen, 5021, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

RF-ablation

Procedure

4mm-tip catheter manually guided vs magneticallly navigated

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

Sponsors and collaborators

Lead sponsor

Deutsches Herzzentrum Muenchen

Other

Collaborators

  • University of Bergen

Registry information

Official study title

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

Acronym: MAGMA-AVNRT

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Apr 6, 2009
Registry last updated
Jun 27, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.