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

Phase 4

Completed

• Conditions: Atrioventricular Nodal Reentry Tachycardia; Radiofrequency Ablation
• Interventions: Procedure: RF-ablation

• Registration Number: NCT00875914
• Lead Sponsor: Deutsches Herzzentrum Muenchen

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.

Study Timeline

• Study Start: 2009-04
• Study First Submitted: 2009-04-03
• Study First Submitted QC: 2009-04-03
• Study First Posted: 2009-04-06
• Primary Completion: 2012-03
• Study Completion: 2012-10
• Status Verified: 2016-06
• Last Update Submitted: 2016-06-24
• Last Update Posted: 2016-06-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Manually guided	RF-ablation	Treatment with manually guided RF-catheter
Magnetically navigated	RF-ablation	Treatment with magnetically navigated RF-catheter.

Primary Outcome Measures

Name	Time	Method
Total x-ray time and dose for patient	electrophysiological examination

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University Hospital Bergen; 🇳🇴 Bergen, Norway