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Magnetically Navigated vs. Manually Guided Radiofrequency in Atrioventricular-node-reentry-tachycardia (MAGMA-AVNRT)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00875914
First Posted: April 6, 2009
Last Update Posted: June 27, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
University of Bergen
Information provided by:
Deutsches Herzzentrum Muenchen
  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
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Comparison Between Magnetically Navigated vs Manually Guided Radiofrequency in AV-node-reentry-tachycardia

Further study details as provided by Deutsches Herzzentrum Muenchen:

Primary Outcome Measures:
  • Total x-ray time and dose for patient [ Time Frame: electrophysiological examination ]

Secondary Outcome Measures:
  • X-ray time and dose for physician [ Time Frame: electrophysiological study ]
  • Safety of ablation (AV-Block, perforation) [ Time Frame: end of electrophysiological study ]
  • short-term and long-term-success [ Time Frame: end of procedure and 6 months after procedure ]
  • number of RF-application [ Time Frame: procedure ]
  • Duration of electrophysiological study (ablation included) [ Time Frame: procedure ]

Estimated Enrollment: 300
Study Start Date: April 2009
Study Completion Date: October 2012
Primary Completion Date: March 2012 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00875914


Locations
Norway
University Hospital Bergen
Bergen, Norway, 5021
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

Responsible Party: Gabi Hessling MD, Deutsches Herzzentrum Muenchen
ClinicalTrials.gov Identifier: NCT00875914     History of Changes
Other Study ID Numbers: GE IDE No. C00909
First Submitted: April 3, 2009
First Posted: April 6, 2009
Last Update Posted: June 27, 2016
Last Verified: June 2016

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