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

Radiofrequency Ablation Clinical Trial

— MAGMA-AVNRT  

Official title:

Randomized Comparison Between Magnetically Navigated vs Manually Guided Radiofrequency in AV-node-reentry-tachycardia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00875914
• Other study ID #: GE IDE No. C00909
• Status: Completed
• Phase: Phase 4
• First received: April 3, 2009
• Last updated: June 24, 2016
• Start date: April 2009
• Est. completion date: October 2012

Study information

• Verified date: June 2016
• Source: Deutsches Herzzentrum Muenchen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: October 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atrioventricular Nodal Reentry Tachycardia
• Radiofrequency Ablation
• Tachycardia
• Tachycardia, Atrioventricular Nodal Reentry

Intervention

Procedure:
• RF-ablation
4mm-tip catheter manually guided vs magneticallly navigated

Locations

Country	Name	City	State
Norway	University Hospital Bergen	Bergen

Sponsors (2)

Lead Sponsor	Collaborator
Deutsches Herzzentrum Muenchen	University of Bergen

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total x-ray time and dose for patient		electrophysiological examination	No
Secondary	X-ray time and dose for physician		electrophysiological study	Yes
Secondary	Safety of ablation (AV-Block, perforation)		end of electrophysiological study	Yes
Secondary	short-term and long-term-success		end of procedure and 6 months after procedure	No
Secondary	number of RF-application		procedure	No
Secondary	Duration of electrophysiological study (ablation included)		procedure	No