Magnetically Navigated vs. Manually Guided Radiofrequency in Atrioventricular-Node-Reentry-Tachycardia (MAGMA-AVNRT)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2009 by Deutsches Herzzentrum Muenchen.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
University of Bergen
Information provided by:
Deutsches Herzzentrum Muenchen
ClinicalTrials.gov Identifier:
NCT00875914
First received: April 3, 2009
Last updated: May 18, 2009
Last verified: May 2009
  Purpose

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.


Condition Intervention Phase
Atrioventricular Nodal Reentry Tachycardia
Radiofrequency Ablation
Procedure: RF-ablation
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Comparison Between Magnetically Navigated vs Manually Guided Radiofrequency in AV-Node-Reentry-Tachycardia

Resource links provided by NLM:


Further study details as provided by Deutsches Herzzentrum Muenchen:

Primary Outcome Measures:
  • Total x-ray time and dose for patient [ Time Frame: electrophysiological examination ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • X-ray time and dose for physician [ Time Frame: electrophysiological study ] [ Designated as safety issue: Yes ]
  • Safety of ablation (AV-Block, perforation) [ Time Frame: end of electrophysiological study ] [ Designated as safety issue: Yes ]
  • short-term and long-term-success [ Time Frame: end of procedure and 6 months after procedure ] [ Designated as safety issue: No ]
  • number of RF-application [ Time Frame: procedure ] [ Designated as safety issue: No ]
  • Duration of electrophysiological study (ablation included) [ Time Frame: procedure ] [ Designated as safety issue: No ]

Estimated Enrollment: 300
Study Start Date: April 2009
Estimated Study Completion Date: February 2011
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Manually guided
Treatment with manually guided RF-catheter
Procedure: RF-ablation
4mm-tip catheter manually guided vs magneticallly navigated
Experimental: Magnetically navigated
Treatment with magnetically navigated RF-catheter.
Procedure: RF-ablation
4mm-tip catheter manually guided vs magneticallly navigated

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00875914

Contacts
Contact: Clemens Jilek, MD +49 89 1218 ext 2020 jilek@dhm.mhn.de

Locations
Norway
University Hospital Bergen Recruiting
Bergen, Norway, 5021
Contact: Peter Schuster, MD       Peter.Schuster@med.uib.no   
Principal Investigator: Peter Schuster, MD         
Sponsors and Collaborators
Deutsches Herzzentrum Muenchen
University of Bergen
Investigators
Study Chair: Gabi Hessling, MD Deutsches Herzzentrum München
Study Chair: Peter Schuster, MD University of Bergen
Study Chair: Isabel Deisenhofer, MD Deutsches Herzzentrum München
  More Information

No publications provided

Responsible Party: Gabi Hessling MD, Deutsches Herzzentrum Muenchen
ClinicalTrials.gov Identifier: NCT00875914     History of Changes
Other Study ID Numbers: GE IDE No. C00909
Study First Received: April 3, 2009
Last Updated: May 18, 2009
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Deutsches Herzzentrum Muenchen:
AV-node reentry tachycardia
radiofrequency ablation
magnetic navigation system

Additional relevant MeSH terms:
Tachycardia
Tachycardia, Atrioventricular Nodal Reentry
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Tachycardia, Reciprocating

ClinicalTrials.gov processed this record on April 23, 2014