Trial record 9 of 110 for:
Open Studies | "Tachycardia"
Magnetically Navigated vs. Manually Guided Radiofrequency in Atrioventricular-Node-Reentry-Tachycardia (MAGMA-AVNRT)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2009 by Deutsches Herzzentrum Muenchen.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Deutsches Herzzentrum Muenchen
Collaborator:
University of Bergen
Information provided by:
Deutsches Herzzentrum Muenchen
ClinicalTrials.gov Identifier:
NCT00875914
First received: April 3, 2009
Last updated: May 18, 2009
Last verified: May 2009
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Atrioventricular Nodal Reentry Tachycardia Radiofrequency Ablation |
Procedure: RF-ablation |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Randomized Comparison Between Magnetically Navigated vs Manually Guided Radiofrequency in AV-Node-Reentry-Tachycardia |
Resource links provided by NLM:
Further study details as provided by Deutsches Herzzentrum Muenchen:
Primary Outcome Measures:
- Total x-ray time and dose for patient [ Time Frame: electrophysiological examination ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- X-ray time and dose for physician [ Time Frame: electrophysiological study ] [ Designated as safety issue: Yes ]
- Safety of ablation (AV-Block, perforation) [ Time Frame: end of electrophysiological study ] [ Designated as safety issue: Yes ]
- short-term and long-term-success [ Time Frame: end of procedure and 6 months after procedure ] [ Designated as safety issue: No ]
- number of RF-application [ Time Frame: procedure ] [ Designated as safety issue: No ]
- Duration of electrophysiological study (ablation included) [ Time Frame: procedure ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 300 |
| Study Start Date: | April 2009 |
| Estimated Study Completion Date: | February 2011 |
| Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Manually guided
Treatment with manually guided RF-catheter
|
Procedure: RF-ablation
4mm-tip catheter manually guided vs magneticallly navigated
|
|
Experimental: Magnetically navigated
Treatment with magnetically navigated RF-catheter.
|
Procedure: RF-ablation
4mm-tip catheter manually guided vs magneticallly navigated
|
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| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00875914
Contacts
| Contact: Clemens Jilek, MD | +49 89 1218 ext 2020 | jilek@dhm.mhn.de |
Locations
| Norway | |
| University Hospital Bergen | Recruiting |
| Bergen, Norway, 5021 | |
| Contact: Peter Schuster, MD Peter.Schuster@med.uib.no | |
| Principal Investigator: Peter Schuster, MD | |
Sponsors and Collaborators
Deutsches Herzzentrum Muenchen
University of Bergen
Investigators
| Study Chair: | Gabi Hessling, MD | Deutsches Herzzentrum München |
| Study Chair: | Peter Schuster, MD | University of Bergen |
| Study Chair: | Isabel Deisenhofer, MD | Deutsches Herzzentrum München |
More Information
No publications provided
| Responsible Party: | Gabi Hessling MD, Deutsches Herzzentrum Muenchen |
| ClinicalTrials.gov Identifier: | NCT00875914 History of Changes |
| Other Study ID Numbers: | GE IDE No. C00909 |
| Study First Received: | April 3, 2009 |
| Last Updated: | May 18, 2009 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Keywords provided by Deutsches Herzzentrum Muenchen:
|
AV-node reentry tachycardia radiofrequency ablation magnetic navigation system |
Additional relevant MeSH terms:
|
Tachycardia Tachycardia, Atrioventricular Nodal Reentry Arrhythmias, Cardiac Heart Diseases |
Cardiovascular Diseases Pathologic Processes Tachycardia, Reciprocating |
ClinicalTrials.gov processed this record on May 21, 2013