Atrial FibrillationNCT00184249
A Prospective Multi Centre Trial on Bipolar Radiofrequency Ablation of Atrial Fibrillation
A study testing Bipolar radiofrequency ablation in people with Atrial Fibrillation, run by Norwegian University of Science and Technology.
Trial summary
The study is a prospective multi-centre study to investigate the effect of a new bipolar ablation strategy of the left atrium in patients with paroxysmal or permanent atrial fibrillation over time. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Bipolar radiofrequency ablation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jun 2005to Jun 2012
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- referred for elective heart surgery with extracorporeal circulation
- suffers from AF for more than 6 months but less than 7 years
- aged between 18 and 80 years
- ejection fraction above 30 %
Who cannot join
- Reoperations
- NYHA class IV
- Ischemic mitral incompetence
- Creatinine > 140
- Transmural myocardial infarction < 4 weeks
- Endocarditis
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- Serious peripheral vascular disease
- Pregnancy or breast-feeding
- Drug addiction
- Size of left atrium > 60 mm in preoperative echo-doppler investigation.
- Disease or other condition when the patient is unable to understand the objectives and the scope of the study.
About this study
The study is a prospective multi-centre study to investigate the effect of a new bipolar ablation strategy of the left atrium in patients with paroxysmal or permanent atrial fibrillation over time.
Read the detailed description
Atrial fibrillation (AF) is the most common persistent arrhythmia, prevalent in about 6% of the population over 65 years of age. AF reduces the quality of life and increases mortality. AF is particularly common in combination with mitral valve disease, but is also detected in about 5% of patients with aortic valve and coronary artery disease. Surgical treatment of AF with the Cox-maze III operation was developed by J. Cox during the 80ies. The aim of the operation is to block spread of irregular electrical activity by creating lines of isolation in the atrial musculature. The operation achieves sinus rhythm in over 90% in selected patients. Nevertheless the method was only used in few heart surgical centres, because it is complex and time consuming.In recent years alternative energy sources have been developed to create isolating lines without cutting the tissue and thus making ablation treatment easier. Bipolar radiofrequency ablation is special because the energy is delivered feedback controlled until transmurality is achieved. This is a prerequisite for a good result and makes using the equipment safer.
Since the development of the Cox-maze procedure, our knowledge of atrial fibrillation and its treatment has increased considerably. There is a consensus that the posterior part of the left atrium and in particular the pulmonary veins are an important target for treatment. Surgical ablation with alternative energy sources is a new method under continued development and evaluation.
The optimal ablation treatment is unknown. A balance between invasiveness and achieving sinus rhythm in as many as possible has to be found. Creating numerous ablation lines in both atria is time consuming and leads probably to an increased need for permanent pacemaker implantation and reduced contractility of the atrial tissue. On the other hand can a simple bipolar ablation of pulmonary veins performed easily, but this is probably an insufficient treatment for most patients. In the protocol a new method using solely bipolar ablation for creation of several ablation lines in the left atrium is described.
The study is a prospective multi-centre study to investigate the effect of a new bipolar ablation strategy of the left atrium in patients with paroxysmal or permanent AF over time.
- Conditions
- Atrial Fibrillation
- Being tested
- Bipolar radiofrequency ablation
- Keywords
- Catheter ablation, Heart/surgery, Cardial surgical procedures
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bipolar radiofrequency ablationProcedure or surgery
Also called Cardioblade, Atricure
Ablation using CE marked bipolar ablation devices
| Study group | Role | What they receive |
|---|---|---|
| Bipolar radiofrequency ablation | Experimental | Not described Receives: Procedure: Bipolar radiofrequency ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients in sinus rhythm after 3, 6, and 12 months
Measured: 3, 6,
Number of patients with atrial function at echo-doppler after 6 and 12 months
Measured: 3,6, 12 months
Number of patients on anticoagulants after 6 and 12 months
Measured: 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startJun 2005
- Primary completionJun 2010
- Study completionJun 2012
Why it stopped: Collaborators did not enter patients into the study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Norwegian University of Science and TechnologyThe 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- St. Olavs Hospital, Oslo University Hospital, Haukeland Sykehus HF, Ullevaal University Hospital, Regionssykehuset i Tromsø HF, Feiringklinikken
- Responsible party
- Sponsor
- Investigators
- Alexander Wahba, Prof, Study director, Norwegian University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00184249
- Sponsor's protocol ID
- 120905
- Status last verified
- Mar 2015
- First submitted
- 13 Sep 2005
- Last updated
- 20 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Multi Centre Trial on Bipolar Radiofrequency Ablation of Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT00184249
- Acronym / sponsor ID
- 120905
- Conditions
- Atrial Fibrillation
- Keywords
- Catheter ablation, Heart/surgery, Cardial surgical procedures
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Collaborators did not enter patients into the study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Collaborators
- St. Olavs Hospital, Oslo University Hospital, Haukeland Sykehus HF, Ullevaal University Hospital, Regionssykehuset i Tromsø HF, Feiringklinikken
- Study start
- Jun 2005
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 16 Sep 2005 (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 study is a prospective multi-centre study to investigate the effect of a new bipolar ablation strategy of the left atrium in patients with paroxysmal or permanent atrial fibrillation over time.
Detailed description
Atrial fibrillation (AF) is the most common persistent arrhythmia, prevalent in about 6% of the population over 65 years of age. AF reduces the quality of life and increases mortality. AF is particularly common in combination with mitral valve disease, but is also detected in about 5% of patients with aortic valve and coronary artery disease. Surgical treatment of AF with the Cox-maze III operation was developed by J. Cox during the 80ies. The aim of the operation is to block spread of irregular electrical activity by creating lines of isolation in the atrial musculature. The operation achieves sinus rhythm in over 90% in selected patients. Nevertheless the method was only used in few heart surgical centres, because it is complex and time consuming.In recent years alternative energy sources have been developed to create isolating lines without cutting the tissue and thus making ablation treatment easier. Bipolar radiofrequency ablation is special because the energy is delivered feedback controlled until transmurality is achieved. This is a prerequisite for a good result and makes using the equipment safer.
Since the development of the Cox-maze procedure, our knowledge of atrial fibrillation and its treatment has increased considerably. There is a consensus that the posterior part of the left atrium and in particular the pulmonary veins are an important target for treatment. Surgical ablation with alternative energy sources is a new method under continued development and evaluation.
The optimal ablation treatment is unknown. A balance between invasiveness and achieving sinus rhythm in as many as possible has to be found. Creating numerous ablation lines in both atria is time consuming and leads probably to an increased need for permanent pacemaker implantation and reduced contractility of the atrial tissue. On the other hand can a simple bipolar ablation of pulmonary veins performed easily, but this is probably an insufficient treatment for most patients. In the protocol a new method using solely bipolar ablation for creation of several ablation lines in the left atrium is described.
The study is a prospective multi-centre study to investigate the effect of a new bipolar ablation strategy of the left atrium in patients with paroxysmal or permanent AF over time.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bipolar radiofrequency ablation | Experimental | Procedure: Bipolar radiofrequency ablation |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- referred for elective heart surgery with extracorporeal circulation
- suffers from AF for more than 6 months but less than 7 years
- aged between 18 and 80 years
- ejection fraction above 30 %
Key exclusion criteria (11 listed)
- Reoperations
- NYHA class IV
- Ischemic mitral incompetence
- Creatinine > 140
- Transmural myocardial infarction < 4 weeks
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 |
|---|---|---|
| Bipolar radiofrequency ablationAlso: Cardioblade, AtricureAblation using CE marked bipolar ablation devices | Procedure or surgery | Bipolar radiofrequency ablation |
Primary outcome
Number of patients in sinus rhythm after 3, 6, and 12 months
Time frame: 3, 6,
Number of patients with atrial function at echo-doppler after 6 and 12 months
Time frame: 3,6, 12 months
Number of patients on anticoagulants after 6 and 12 months
Time frame: 6 and 12 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2015.
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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.
Alexander Wahba, Prof study director
Norwegian University of Science and Technology
Questions about this trial
What is this clinical trial studying?
A study testing Bipolar radiofrequency ablation in people with Atrial Fibrillation, run by Norwegian University of Science and Technology.
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 4 inclusion and 11 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: withdrawn, as of the sponsor's last update on 20 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Number of patients in sinus rhythm after 3, 6, and 12 months (time frame: 3, 6,). The study lists 3 primary outcomes in all. 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 20 Mar 2015.