Pulmonary Vein Isolation, Ablation Time, Procedure Time, Freedom Form Atrial FibrillationNCT01583075
Pulmonary Vein Ablation of Atrial Fibrillation Using Magnetic Navigation: Single Ring Versus Circumferential Techniques
A study testing Circumferential pulmonary vein ablation and single ring pulmonary vein ablation in people with Pulmonary Vein Isolation, Ablation Time, Procedure Time, Freedom Form Atrial Fibrillation, run by University Medical Center Goettingen at 1 site in Germany.
Trial summary
The single-ring ablation method aims for isolation of the posterior LA wall including the pulmonary veins. If avoiding ablation on the posterior LA wall esophageal injury is unlikely. Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Pulmonary Vein Isolation, Ablation Time, Procedure Time, Freedom Form Atrial Fibrillation
- What is being tested?
- Circumferential pulmonary vein ablation and single ring pulmonary vein ablation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteGermany
- Study dates
- Dec 2009to Mar 2011
- 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 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- drug refractory AF patients undergoing PVA
Who cannot join
- drug refractory AF patients undergoing repeat PVA
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pulmonary Vein Ablation With Magnetic Navigation in Patients With Therapy-refractory Symptomatic Atrial Fibrillation: Comparison of "Single Ring" and Circumferential Ablation Techniques
The single-ring ablation method aims for isolation of the posterior LA wall including the pulmonary veins. If avoiding ablation on the posterior LA wall esophageal injury is unlikely.
Aim of this prospective study was to evaluate the safety and efficacy of an RMN-guided single-ring ablation method as compared to standard RMN-guided circumferential PVA.
- Being tested
- Circumferential pulmonary vein ablation, single ring pulmonary vein ablation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Circumferential pulmonary vein ablationProcedure or surgery
Circumferential pulmonary vein ablation
single ring pulmonary vein ablationProcedure or surgery
single ring pulmonary vein ablation
| Study group | Role | What they receive |
|---|---|---|
| Circumferential ablation | Other | Not described Receives: Procedure: Circumferential pulmonary vein ablation |
| Single ring ablation | Experimental | Not described Receives: Procedure: single ring pulmonary vein ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute procedural success
number of PVs isolated at the end of the ablation procedure
Measured: After the end of the ablation procedure
Secondary outcomes (1)
Long-term procedural success
long-term freedom from any AT/AF episodes
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2012 (estimated)
- Study startDec 2009
- Primary completionMar 2011
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 Pulmonary Vein Isolation, Ablation Time, Procedure Time, Freedom Form Atrial FibrillationStudies 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Center Goettingen
- Sponsor type
- University, hospital or other
- Collaborators
- Stereotaxis
- Responsible party
- Principal investigator, Markus Zabel, University Medical Center Goettingen
- Investigators
- Markus Zabel, MD, Principal investigator, Clinical Electrophysiology, University Medical Center Goettingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01583075
- Sponsor's protocol ID
- STXS 10-005
- Status last verified
- Apr 2012
- First submitted
- 20 Apr 2012
- Last updated
- 24 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Thomas SP, Lim TW, McCall R, Seow SC, Ross DL. Electrical isolation of the posterior left atrial wall and pulmonary veins for atrial fibrillation: feasibility of and rationale for a single-ring approach. Heart Rhythm. 2007 Jun;4(6):722-30. doi: 10.1016/j.hrthm.2007.01.034. Epub 2007 Feb 9.
PubMed 17556191
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulmonary Vein Ablation With Magnetic Navigation in Patients With Therapy-refractory Symptomatic Atrial Fibrillation: Comparison of "Single Ring" and Circumferential Ablation Techniques
- ClinicalTrials.gov ID
- NCT01583075
- Acronym / sponsor ID
- STXS 10-005
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University Medical Center GoettingenUniversity, hospital or other
- Collaborators
- Stereotaxis
- Study start
- Dec 2009
- Primary completion
- Mar 2011 (actual)
- First posted
- 23 Apr 2012 (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 single-ring ablation method aims for isolation of the posterior LA wall including the pulmonary veins. If avoiding ablation on the posterior LA wall esophageal injury is unlikely.
Aim of this prospective study was to evaluate the safety and efficacy of an RMN-guided single-ring ablation method as compared to standard RMN-guided circumferential PVA.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Circumferential ablation | Other | Procedure: Circumferential pulmonary vein ablation |
| Single ring ablation | Experimental | Procedure: single ring pulmonary vein ablation |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- drug refractory AF patients undergoing PVA
Key exclusion criteria (1 listed)
- drug refractory AF patients undergoing repeat PVA
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 |
|---|---|---|
| Circumferential pulmonary vein ablationCircumferential pulmonary vein ablation | Procedure or surgery | Circumferential ablation |
| single ring pulmonary vein ablationsingle ring pulmonary vein ablation | Procedure or surgery | Single ring ablation |
Primary outcome
Acute procedural success
Time frame: After the end of the ablation procedure
number of PVs isolated at the end of the ablation procedure
1 secondary outcome
Long-term procedural success
Time frame: 12 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 24 Apr 2012.
- Background: PubMed 17556191Thomas SP, Lim TW, McCall R, Seow SC, Ross DL. Electrical isolation of the posterior left atrial wall and pulmonary veins for atrial fibrillation: feasibility of and rationale for a single-ring approach. Heart Rhythm. 2007 Jun;4(6):722-30. doi: 10.1016/j.hrthm.2007.01.034. Epub 2007 Feb 9.
Related trials for Pulmonary Vein Isolation, Ablation Time, Procedure Time, Freedom Form Atrial Fibrillation
Recruiting
FIH Study of PFLotus in Persistent Atrial Fibrillation
Persistent Atrial Fibrillation
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.
Markus Zabel, MD principal investigator
Clinical Electrophysiology, University Medical Center 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 Circumferential pulmonary vein ablation and single ring pulmonary vein ablation in people with Pulmonary Vein Isolation, Ablation Time, Procedure Time, Freedom Form Atrial Fibrillation, run by University Medical Center 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 1 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 24 Apr 2012. 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?
Acute procedural success (time frame: After the end of the ablation procedure). 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 NCT01583075, 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 24 Apr 2012.