Magnetically Navigated vs. Manually Guided Radiofrequency in Atrioventricular-Node-Reentry-Tachycardia - Full Text View

Sponsor:	Deutsches Herzzentrum Muenchen
Collaborator:	University of Bergen
Information provided by:	Deutsches Herzzentrum Muenchen
ClinicalTrials.gov Identifier:	NCT00875914

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 IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Official Title:	Randomized Comparison Between Magnetically Navigated vs Manually Guided Radiofrequency in AV-Node-Reentry-Tachycardia

Resource links provided by NLM:

Genetics Home Reference related topics: Brugada syndrome short QT syndrome

MedlinePlus related topics: X-Rays

U.S. FDA Resources

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
Manually guided: Experimental Treatment with manually guided RF-catheter	Procedure: RF-ablation 4mm-tip catheter manually guided vs magneticallly navigated
Magnetically navigated: Experimental 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:	Deutsches Herzzentrum Muenchen ( Gabi Hessling MD )
Study ID Numbers:	GE IDE No. C00909
Study First Received:	April 3, 2009
Last Updated:	May 18, 2009
ClinicalTrials.gov Identifier:	NCT00875914 History of Changes
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:

Pathologic Processes
Heart Diseases
Tachycardia
Cardiovascular Diseases

Tachycardia, Reciprocating
Tachycardia, Atrioventricular Nodal Reentry
Arrhythmias, Cardiac

ClinicalTrials.gov processed this record on February 09, 2010