ArrythmiaNCT00524602
The Use of Remote Magnetic Navigation in Catheter Ablation of Heart Arrythmia
A study testing Catheter ablation using the Stereotaxis equipment in people with Arrythmia, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
Patients with several heart arrythmia can potentially be cured by catheterablation. For some arrythmias 95% of the patients are cured. Also patients with atrial fibrillation are cured by catherablation even though the effect is not as impressive as for other cardiac arrythmias. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Arrythmia
- What is being tested?
- Catheter ablation using the Stereotaxis equipment
- Type of treatment
- Surgery or procedure
- How many people
- 2,000 participants
- Where
- 1 siteDenmark
- Study dates
- Jun 2007to Jun 2013
- Phase
- Interventional
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Patients with anamnestic psycosis or other conditions where information is impossible or insure to give
- Contraindication to magnetic ablation therapy
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Rigshospitalet
Copenhagen, DK-2100
Jesper H Svendsen, MD, (+45) 3545 2817, hastrup@rh.dk
About this study
Official title: A Nonrandomized Observertionel Study That Will Show the Utility and the Safety by Using the Remote Magnetic Navigation of Ablationcatheters and the Stereotaxis Equipment
Patients with several heart arrythmia can potentially be cured by catheterablation. For some arrythmias 95% of the patients are cured. Also patients with atrial fibrillation are cured by catherablation even though the effect is not as impressive as for other cardiac arrythmias. About 70% of patients with paroxystic and persistant atrial fibrillation are cured. Most of the remaining obtain a reduction of their symptoms.
At conventional ablation of atrial fibrillation the catheters are manually navigated to the ideal anatomic position where to isolate the pulmonary veins from the left atrium.
Read more
Lately it has been possible to navigate the ablationcatheters using 'remote magnetic navigation' using a magnetic based navigation equipment, Stereotaxis.
The Heartcentre of Rigshospitalet had this Stereotaxis equipment installed in the autumn of 2006.
We will investigate the utility and safety of using this remote magnetic navigation/Stereotaxis.
Read the detailed description
The purpose on this study is to show the utility and the safety by using the remote magnetic navigation of ablation catheters with the Stereotaxis equipment at ablations of
- atrial fibrillation, atrial flutter and other arrythmias
- childrens arrythmias
- arrythmias of patients with pacemaker or ICD (Implantable Cardiac Defibrillator)
- Conditions
- Arrythmia
- Being tested
- Catheter ablation using the Stereotaxis equipment
- Keywords
- Stereotaxis, Arrythmia, Catheter ablation, Heart
- Medical subject headings
- Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Catheter ablation using the Stereotaxis equipmentProcedure or surgery
Also called Radiofrequency ablation
Energy delivery through ablation catheter during an interventional catheterisation of the heart.
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical effect and safety of ablation
Stroke and death
Measured: 3 month after procedure
Secondary outcomes (1)
Feasibility of remote navigation
Succesrate
Measured: within 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2007 (estimated)
- Study startJun 2007
- Primary completionJun 2012 (estimated)
- Study completionJun 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ArrythmiaStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Investigators
- Xu Chen, MD, Principal investigator, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00524602
- Sponsor's protocol ID
- STEREOTAXIS study
- Other IDs
- No funding
- Status last verified
- Aug 2007
- First submitted
- 31 Aug 2007
- Last updated
- 11 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Nonrandomized Observertionel Study That Will Show the Utility and the Safety by Using the Remote Magnetic Navigation of Ablationcatheters and the Stereotaxis Equipment
- ClinicalTrials.gov ID
- NCT00524602
- Acronym / sponsor ID
- STEREOTAXIS study
- Conditions
- Arrythmia
- Keywords
- Stereotaxis, Arrythmia, Catheter ablation, Heart
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- Jun 2007
- Primary completion
- Jun 2012 (estimated)
- Study completion
- Jun 2013 (estimated)
- First posted
- 3 Sep 2007 (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.
Patients with several heart arrythmia can potentially be cured by catheterablation. For some arrythmias 95% of the patients are cured. Also patients with atrial fibrillation are cured by catherablation even though the effect is not as impressive as for other cardiac arrythmias. About 70% of patients with paroxystic and persistant atrial fibrillation are cured. Most of the remaining obtain a reduction of their symptoms.
At conventional ablation of atrial fibrillation the catheters are manually navigated to the ideal anatomic position where to isolate the pulmonary veins from the left atrium.
Lately it has been possible to navigate the ablationcatheters using 'remote magnetic navigation' using a magnetic based navigation equipment, Stereotaxis.
The Heartcentre of Rigshospitalet had this Stereotaxis equipment installed in the autumn of 2006.
We will investigate the utility and safety of using this remote magnetic navigation/Stereotaxis.
Detailed description
The purpose on this study is to show the utility and the safety by using the remote magnetic navigation of ablation catheters with the Stereotaxis equipment at ablations of
- atrial fibrillation, atrial flutter and other arrythmias
- childrens arrythmias
- arrythmias of patients with pacemaker or ICD (Implantable Cardiac Defibrillator)
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (2 listed)
- Patients with anamnestic psycosis or other conditions where information is impossible or insure to give
- Contraindication to magnetic ablation therapy
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 |
|---|---|---|
| Catheter ablation using the Stereotaxis equipmentAlso: Radiofrequency ablationEnergy delivery through ablation catheter during an interventional catheterisation of the heart. | Procedure or surgery | – |
Primary outcome
Clinical effect and safety of ablation
Time frame: 3 month after procedure
Stroke and death
1 secondary outcome
Feasibility of remote navigation
Time frame: within 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2011.
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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.
Xu Chen, MD principal investigator
Copenhagen University Hospital, Rigshospitalet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Catheter ablation using the Stereotaxis equipment in people with Arrythmia, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
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 0 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 11 Aug 2011. 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 Denmark. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xu Chen, MD ((+45) 3545 2817, xu.chen@rh.hosp.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical effect and safety of ablation (time frame: 3 month after procedure). 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 11 Aug 2011.