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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 22, 2014