Atrial FlutterNCT00560872
Remote Magnetic Navigation For Cavotricuspid Isthmus Ablation
A study testing remote magnetic catheter navigation and cavotricuspid isthmus ablation in people with Atrial Flutter, run by University Hospital Goettingen at 1 site in Germany.
Trial summary
The purpose of this study is to evaluate the influence of remote magnetic catheter navigation on the safety and efficacy of mapping and radiofrequency ablation of the cavotricuspid isthmus in patients with typical atrial flutter. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Flutter
- What is being tested?
- remote magnetic catheter navigation and cavotricuspid isthmus ablation
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteGermany
- Study dates
- Aug 2007to Jun 2009
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ECG documentation of at least 1 episode of typical atrial flutter
Who cannot join
- Prior right atrial ablation
- Ferromagnetic implants that may interfere with the magnetic navigation system
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Germany1 site
Herzzentrum, Abteilung Kardiologie, Georg-August-Universitaet
Göttingen, 37075
About this study
Official title: Randomized Controlled Study of Remote Magnetic Catheter Navigation for Cavotricuspid Isthmus Mapping and Ablation in Patients With Typical Atrial Flutter
The purpose of this study is to evaluate the influence of remote magnetic catheter navigation on the safety and efficacy of mapping and radiofrequency ablation of the cavotricuspid isthmus in patients with typical atrial flutter.
- Conditions
- Atrial Flutter
- Being tested
- remote magnetic catheter navigation, cavotricuspid isthmus ablation
- Keywords
- atrial flutter, ablation, navigation
- Medical subject headings
- Atrial Flutter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
remote magnetic catheter navigationDevice
use of the Stereotaxis system
cavotricuspid isthmus ablationProcedure or surgery
conventional (manual) approach
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | conventional ablation with manual catheter navigation Receives: Procedure: cavotricuspid isthmus ablation |
| 2 | Active comparator | ablation with remote magnetic catheter navigation Receives: Device: remote magnetic catheter navigation |
What is being measured
The primary outcome is the main question the study is designed to answer.
ablation duration and fluoroscopy time
Measured: 3 months
Secondary outcomes (1)
total procedure duration, success, ablation characteristics, flutter recurrence, complications
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2007 (estimated)
- Study startAug 2007
- Primary completionDec 2008
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atrial FlutterStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Goettingen
- Sponsor type
- University, hospital or other
- Collaborators
- Stereotaxis
- Investigators
- Dirk Vollmann, PD Dr. med., Principal investigator, Herzzentrum, Abteilung Kardiologie, Universitaetsmedizin Goettingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00560872
- Sponsor's protocol ID
- MN-07-022-GOE
- Other IDs
- Stereotaxis#07-022
- Status last verified
- Dec 2009
- First submitted
- 19 Nov 2007
- Last updated
- 23 Dec 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Vollmann D, Luthje L, Seegers J, Hasenfuss G, Zabel M. Remote magnetic catheter navigation for cavotricuspid isthmus ablation in patients with common-type atrial flutter. Circ Arrhythm Electrophysiol. 2009 Dec;2(6):603-10. doi: 10.1161/CIRCEP.109.884411.
PubMed 20009074
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Study of Remote Magnetic Catheter Navigation for Cavotricuspid Isthmus Mapping and Ablation in Patients With Typical Atrial Flutter
- ClinicalTrials.gov ID
- NCT00560872
- Acronym / sponsor ID
- MN-07-022-GOE
- Conditions
- Atrial Flutter
- Keywords
- atrial flutter, ablation, navigation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital GoettingenUniversity, hospital or other
- Collaborators
- Stereotaxis
- Study start
- Aug 2007
- Primary completion
- Dec 2008 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 20 Nov 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.
The purpose of this study is to evaluate the influence of remote magnetic catheter navigation on the safety and efficacy of mapping and radiofrequency ablation of the cavotricuspid isthmus in patients with typical atrial flutter.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Procedure: cavotricuspid isthmus ablationconventional ablation with manual catheter navigation |
| 2 | Active comparator | Device: remote magnetic catheter navigationablation with remote magnetic catheter navigation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- ECG documentation of at least 1 episode of typical atrial flutter
Key exclusion criteria (3 listed)
- Prior right atrial ablation
- Ferromagnetic implants that may interfere with the magnetic navigation system
- Pregnancy
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 |
|---|---|---|
| remote magnetic catheter navigationuse of the Stereotaxis system | Device | 2 |
| cavotricuspid isthmus ablationconventional (manual) approach | Procedure or surgery | 1 |
Primary outcome
ablation duration and fluoroscopy time
Time frame: 3 months
1 secondary outcome
total procedure duration, success, ablation characteristics, flutter recurrence, complications
Time frame: 6 months
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 23 Dec 2009.
- Derived from this study: PubMed 20009074Vollmann D, Luthje L, Seegers J, Hasenfuss G, Zabel M. Remote magnetic catheter navigation for cavotricuspid isthmus ablation in patients with common-type atrial flutter. Circ Arrhythm Electrophysiol. 2009 Dec;2(6):603-10. doi: 10.1161/CIRCEP.109.884411.
Related trials for Atrial Flutter
Recruiting
Feasibility Study on the VERAFEYE Imaging and Navigation System for Guided Catheter Ablation Procedures
Atrial Fibrillation, Atrial Flutter
Recruiting
Anatomical Navigation for Guided Electrophysiology in AFL and AFib
Atrial Fibrillation, Atrial Flutter
RecruitingObservational study
Observational Study of Cardiac Arrhythmias During Treatment With BTK Inhibitors or Venetoclax
Chronic Lymphocytic Leukemia (CLL), Waldenstr(SqrRoot)(Delta)m s Macroglobulinemia
Active, not recruiting
Repeat Ablation of Persistent Atrial Fibrillation, Including Mitral Isthmus Catheter Ablation, With the FARAPULSE Pulsed Field Ablation System
Persistent Atrial Fibrillation
Recruiting
Pericardiotomy in Cardiac Surgery
Atrial Fibrillation, Atrial Flutter
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.
Dirk Vollmann, PD Dr. med. principal investigator
Herzzentrum, Abteilung Kardiologie, Universitaetsmedizin Goettingen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing remote magnetic catheter navigation and cavotricuspid isthmus ablation in people with Atrial Flutter, run by University Hospital Goettingen at 1 site in Germany.
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 1 inclusion and 3 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 23 Dec 2009. 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 Germany. 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?
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?
ablation duration and fluoroscopy time (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00560872, which also lists 1 linked publication.
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 23 Dec 2009.