Atrioventricular Nodal Reentry TachycardiaPhase 4MAGMA-AVNRTNCT00875914
Magnetically Navigated vs. Manually Guided Radiofrequency in Atrioventricular-node-reentry-tachycardia
A Phase 4 study testing RF-ablation in people with Atrioventricular Nodal Reentry Tachycardia and Radiofrequency Ablation, run by Deutsches Herzzentrum Muenchen at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Atrioventricular Nodal Reentry Tachycardia, Radiofrequency Ablation
- What is being tested?
- RF-ablation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteNorway
- Study dates
- Apr 2009to Oct 2012
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 to 70 years old
- suspected AV-node-reentry-tachycardia
- written informed consent
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Comparison Between Magnetically Navigated vs Manually Guided Radiofrequency in AV-node-reentry-tachycardia
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.
Read the 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.
- Being tested
- RF-ablation
- Keywords
- AV-node reentry tachycardia, radiofrequency ablation, magnetic navigation system
- Medical subject headings
- Tachycardia, Atrioventricular Nodal Reentry
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RF-ablationProcedure or surgery
4mm-tip catheter manually guided vs magneticallly navigated
| Study group | Role | What they receive |
|---|---|---|
| Manually guided | Experimental | Treatment with manually guided RF-catheter Receives: Procedure: RF-ablation |
| Magnetically navigated | Experimental | Treatment with magnetically navigated RF-catheter. Receives: Procedure: RF-ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total x-ray time and dose for patient
Measured: electrophysiological examination
Secondary outcomes (5)
X-ray time and dose for physician
Measured: electrophysiological study
Safety of ablation (AV-Block, perforation)
Measured: end of electrophysiological study
short-term and long-term-success
Measured: end of procedure and 6 months after procedure
number of RF-application
Measured: procedure
Duration of electrophysiological study (ablation included)
Measured: procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2009 (estimated)
- Study startApr 2009
- Primary completionMar 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrioventricular Nodal Reentry TachycardiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Deutsches Herzzentrum Muenchen
- Sponsor type
- University, hospital or other
- Collaborators
- University of Bergen
- Investigators
- Gabi Hessling, MD, Study chair, Deutsches Herzzentrum MünchenPeter Schuster, MD, Study chair, University of BergenIsabel Deisenhofer, MD, Study chair, Deutsches Herzzentrum München
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00875914
- Sponsor's protocol ID
- GE IDE No. C00909
- Acronym
- MAGMA-AVNRT
- Status last verified
- Jun 2016
- First submitted
- 3 Apr 2009
- Last updated
- 27 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Comparison Between Magnetically Navigated vs Manually Guided Radiofrequency in AV-node-reentry-tachycardia
- ClinicalTrials.gov ID
- NCT00875914
- Acronym / sponsor ID
- MAGMA-AVNRT / GE IDE No. C00909
- Keywords
- AV-node reentry tachycardia, radiofrequency ablation, magnetic navigation system
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Deutsches Herzzentrum MuenchenUniversity, hospital or other
- Collaborators
- University of Bergen
- Study start
- Apr 2009
- Primary completion
- Mar 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 6 Apr 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Manually guided | Experimental | Procedure: RF-ablationTreatment with manually guided RF-catheter |
| Magnetically navigated | Experimental | Procedure: RF-ablationTreatment with magnetically navigated RF-catheter. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 to 70 years old
- suspected AV-node-reentry-tachycardia
- written informed consent
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RF-ablation4mm-tip catheter manually guided vs magneticallly navigated | Procedure or surgery | Magnetically navigated, Manually guided |
Primary outcome
Total x-ray time and dose for patient
Time frame: electrophysiological examination
5 secondary outcomes
X-ray time and dose for physician
Time frame: electrophysiological study
Safety of ablation (AV-Block, perforation)
Time frame: end of electrophysiological study
short-term and long-term-success
Time frame: end of procedure and 6 months after procedure
number of RF-application
Time frame: procedure
Duration of electrophysiological study (ablation included)
Time frame: procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2016.
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NASVAL-SVT: Nasal Swab Versus Modified Valsalva for Supraventricular Tachycardia
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gabi Hessling, MD study chair
Deutsches Herzzentrum München
Peter Schuster, MD study chair
University of Bergen
Isabel Deisenhofer, MD study chair
Deutsches Herzzentrum München
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing RF-ablation in people with Atrioventricular Nodal Reentry Tachycardia and Radiofrequency Ablation, run by Deutsches Herzzentrum Muenchen at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total x-ray time and dose for patient (time frame: electrophysiological examination). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2016.