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

June 24, 2016 updated by: Deutsches Herzzentrum Muenchen

Randomized Comparison Between Magnetically Navigated vs Manually Guided Radiofrequency in AV-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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

300

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Bergen, Norway, 5021
        • University Hospital Bergen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Total x-ray time and dose for patient
Time Frame: electrophysiological examination
electrophysiological examination

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Deutsches Herzzentrum Muenchen

Collaborators

University of Bergen

Investigators

  • Study Chair: Gabi Hessling, MD, Deutsches Herzzentrum München
  • Study Chair: Peter Schuster, MD, University of Bergen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2009

Primary Completion (Actual)

March 1, 2012

Study Completion (Actual)

October 1, 2012

Study Registration Dates

First Submitted

April 3, 2009

First Submitted That Met QC Criteria

April 3, 2009

First Posted (Estimate)

April 6, 2009

Study Record Updates

Last Update Posted (Estimate)

June 27, 2016

Last Update Submitted That Met QC Criteria

June 24, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GE IDE No. C00909

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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