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

Primary Purpose

Atrioventricular Nodal Reentry Tachycardia, Radiofrequency Ablation

Status
Completed
Phase
Phase 4
Locations
Norway
Study Type
Interventional
Intervention
RF-ablation
Sponsored by
Deutsches Herzzentrum Muenchen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrioventricular Nodal Reentry Tachycardia focused on measuring AV-node reentry tachycardia, radiofrequency ablation, magnetic navigation system

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital Bergen

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Manually guided

Magnetically navigated

Arm Description

Treatment with manually guided RF-catheter

Treatment with magnetically navigated RF-catheter.

Outcomes

Primary Outcome Measures

Total x-ray time and dose for patient

Secondary Outcome Measures

X-ray time and dose for physician
Safety of ablation (AV-Block, perforation)
short-term and long-term-success
number of RF-application
Duration of electrophysiological study (ablation included)

Full Information

First Posted
April 3, 2009
Last Updated
June 24, 2016
Sponsor
Deutsches Herzzentrum Muenchen
Collaborators
University of Bergen
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1. Study Identification

Unique Protocol Identification Number
NCT00875914
Brief Title
Magnetically Navigated vs. Manually Guided Radiofrequency in Atrioventricular-node-reentry-tachycardia
Acronym
MAGMA-AVNRT
Official Title
Randomized Comparison Between Magnetically Navigated vs Manually Guided Radiofrequency in AV-node-reentry-tachycardia
Study Type
Interventional

2. Study Status

Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
April 2009 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
October 2012 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Deutsches Herzzentrum Muenchen
Collaborators
University of Bergen

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrioventricular Nodal Reentry Tachycardia, Radiofrequency Ablation
Keywords
AV-node reentry tachycardia, radiofrequency ablation, magnetic navigation system

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Manually guided
Arm Type
Experimental
Arm Description
Treatment with manually guided RF-catheter
Arm Title
Magnetically navigated
Arm Type
Experimental
Arm Description
Treatment with magnetically navigated RF-catheter.
Intervention Type
Procedure
Intervention Name(s)
RF-ablation
Intervention Description
4mm-tip catheter manually guided vs magneticallly navigated
Primary Outcome Measure Information:
Title
Total x-ray time and dose for patient
Time Frame
electrophysiological examination
Secondary Outcome Measure Information:
Title
X-ray time and dose for physician
Time Frame
electrophysiological study
Title
Safety of ablation (AV-Block, perforation)
Time Frame
end of electrophysiological study
Title
short-term and long-term-success
Time Frame
end of procedure and 6 months after procedure
Title
number of RF-application
Time Frame
procedure
Title
Duration of electrophysiological study (ablation included)
Time Frame
procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gabi Hessling, MD
Organizational Affiliation
Deutsches Herzzentrum München
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Peter Schuster, MD
Organizational Affiliation
University of Bergen
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Isabel Deisenhofer, MD
Organizational Affiliation
Deutsches Herzzentrum München
Official's Role
Study Chair
Facility Information:
Facility Name
University Hospital Bergen
City
Bergen
ZIP/Postal Code
5021
Country
Norway

12. IPD Sharing Statement

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Magnetically Navigated vs. Manually Guided Radiofrequency in Atrioventricular-node-reentry-tachycardia

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