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

German Heart Center Munich

Status and phase: Completed; Phase 4

Conditions: Radiofrequency Ablation; Atrioventricular Nodal Reentry Tachycardia

Treatments: Procedure: RF-ablation

Study type: Interventional

Funder types: Other

Identifiers

NCT00875914

GE IDE No. C00909

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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300 participants in 2 patient groups

Manually guided

Experimental group

Description:

Treatment with manually guided RF-catheter

Treatment:

Procedure: RF-ablation

Magnetically navigated

Experimental group

Description:

Treatment with magnetically navigated RF-catheter.

Treatment:

Procedure: RF-ablation