Clinical trial NCT00875914: Magnetically Navigated vs. Manually Guided Radiofrequency in Atrioventricular-node-reentry-tachycardia
Official title: Randomized Comparison Between Magnetically Navigated vs Manually Guided Radiofrequency in AV-node-reentry-tachycardia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Atrioventricular Nodal Reentry Tachycardia
Radiofrequency Ablation
Keywords: AV-node reentry tachycardia
radiofrequency ablation
magnetic navigation system
Lead sponsor: Deutsches Herzzentrum Muenchen
Sponsor class: OTHER
Collaborators: name: University of Bergen
First posted: 2009-04-06
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Total x-ray time and dose for patient
timeFrame: electrophysiological examination
Secondary outcomes:
measure: X-ray time and dose for physician
timeFrame: electrophysiological study
measure: Safety of ablation (AV-Block, perforation)
timeFrame: end of electrophysiological study
measure: short-term and long-term-success
timeFrame: end of procedure and 6 months after procedure
measure: number of RF-application
timeFrame: procedure
measure: Duration of electrophysiological study (ablation included)
timeFrame: procedure
Other outcomes:
Locations:
city: Bergen
country: Norway
facility: University Hospital Bergen
Study officials:
affiliation: Deutsches Herzzentrum München
name: Gabi Hessling, MD
role: STUDY_CHAIR
affiliation: University of Bergen
name: Peter Schuster, MD
role: STUDY_CHAIR
affiliation: Deutsches Herzzentrum München
name: Isabel Deisenhofer, MD
role: STUDY_CHAIR
References: