Randomized Comparison Between Magnetically Navigated vs Manually Guided Radiofrequency in AV-node-reentry-tachycardia
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 300
- Locations
- 1
- Primary Endpoint
- Total x-ray time and dose for patient
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
Manually guided
Treatment with manually guided RF-catheter
Intervention: RF-ablation (Procedure)
Magnetically navigated
Treatment with magnetically navigated RF-catheter.
Intervention: RF-ablation (Procedure)
Outcomes
Primary Outcomes
Total x-ray time and dose for patient
Time Frame: electrophysiological examination
Secondary Outcomes
- 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)