Atrioventricular Nodal Reentry Tachycardia, Radiofrequency Ablation
Conditions
Keywords
AV-node reentry tachycardia, radiofrequency ablation, magnetic navigation system
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.
Interventions
PROCEDURERF-ablation
4mm-tip catheter manually guided vs magneticallly navigated
Sponsors
University of Bergen
Deutsches Herzzentrum Muenchen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total x-ray time and dose for patient | electrophysiological examination |
Secondary
| Measure | Time frame |
|---|---|
| X-ray time and dose for physician | electrophysiological study |
| Safety of ablation (AV-Block, perforation) | end of electrophysiological study |
| short-term and long-term-success | end of procedure and 6 months after procedure |
| number of RF-application | procedure |
| Duration of electrophysiological study (ablation included) | procedure |
Countries
Norway
Outcome results
None listed