Atrial FibrillationNCT00296166
Catheter Ablation Versus Thoracoscopic Ablation to Patients With Permanent Atrial Fibrillation
A study testing Catheter ablation and Thoracoscopic epicardial ablation in people with Atrial Fibrillation, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
Patents with atrial fibrillation can be treated with the purpose of curing the arrhythmia.This may be achieved by catheter ablation and Maze surgery where the latter includes open heart surgery. By catheter ablation the arrhythmia can be cured in about 70 % of patients who have episodes of atrial fibrillation. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Catheter ablation and Thoracoscopic epicardial ablation
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- 1 siteDenmark
- Study dates
- Nov 2006to Nov 2010
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Permanent atrial fibrillation documented on at least 2 ecg´s with more than 1 month between ecg´s. The diagnosis is verified on Holter.
- All patients have symptoms or do not tolerate rate control treatment.
Who cannot join
- Psychiatric disease or suspicion of incapability to give informed concent
- Females with birth giving potential
- Previous heart surgery
- Previous ablation for atrial fibrillation
- Life expectance less than 1 year
- Congenital heart disease
Show all 10Show fewer
- Expected need for heart surgery
- Heart failure (NYHA class IV)
- Inability to be treated with anticoagulation
- In case of previous deep venous thromboembolism og stroke the investigators will individually consider if the patient is suitable for inclusion.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Study That Will Show the Effects of Catheter Ablation Compared to the Effects of Thoracoscopic Ablation to Patients With Permanent Atrial Fibrillation.
Patents with atrial fibrillation can be treated with the purpose of curing the arrhythmia.This may be achieved by catheter ablation and Maze surgery where the latter includes open heart surgery.
By catheter ablation the arrhythmia can be cured in about 70 % of patients who have episodes of atrial fibrillation. In patients with permanent atrial fibrillation the results are not as good.
We will compare a conventional ablation approach where lesions are created on the inside of the heart with a thoracoscopic approach where the lesions are created from the outside of the heart.
Read the detailed description
Patients with permanent atrial fibrillation will be considered for randomisation Patients will be randomised to either conventional endocardial catheter ablation or epicardial thoracoscopic ablation.
Objectives of study:
Primary endpoint:presence of sinus rhythm after 6 months Secondary endpoints: complications, cost-effectiveness, structural changes (evaluated by echocardiography), p-BNP and inflammatory markers, atrial fibrillation burden evaluated by Holter monitoring
- Conditions
- Atrial Fibrillation
- Being tested
- Catheter ablation, Thoracoscopic epicardial ablation
- Keywords
- Atrial fibrillation, Permanent Atrial fibrillation, catheter ablation, thoracoscopy, Arrhythmia, Heart
- Medical subject headings
- Atrial Fibrillation, Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Catheter ablationProcedure or surgery
Thoracoscopic epicardial ablationProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of sinus rhythm
Measured: after 6 months from treatment
Secondary outcomes (8)
complications
Measured: during 12 months from treatment
cost-effectiveness
Measured: during 12 months from treatment
structural changes (evaluated by echocardiography)
Measured: during 12 months from treatment
p-BNP
Measured: during 12 months from treatment
inflammatory markers
Measured: during 12 months from treatment
atrial fibrillation burden evaluated by Holter monitoring
Measured: at 6 months from treatment
exercise performance
Measured: at 3 months from treatment
Quality of life
Measured: at 3 months from treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2006 (estimated)
- Study startNov 2006
- Study completionNov 2010 (estimated)
Why it stopped: Patients with permanent AF are seldomly symptomatic enough to justify intervention. We decided to stop inclusion due to low recruitment rate.
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 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Investigators
- Jesper H Svendsen, MD, Principal investigator, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00296166
- Sponsor's protocol ID
- KAT-SKOPI study
- Other IDs
- KF - 01-284215
- Status last verified
- Jul 2007
- First submitted
- 23 Feb 2006
- Last updated
- 2 Sep 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Study That Will Show the Effects of Catheter Ablation Compared to the Effects of Thoracoscopic Ablation to Patients With Permanent Atrial Fibrillation.
- ClinicalTrials.gov ID
- NCT00296166
- Acronym / sponsor ID
- KAT-SKOPI study
- Conditions
- Atrial Fibrillation
- Keywords
- Atrial fibrillation, Permanent Atrial fibrillation, catheter ablation, thoracoscopy, Arrhythmia, Heart
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Patients with permanent AF are seldomly symptomatic enough to justify intervention. We decided to stop inclusion due to low recruitment rate.
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- Nov 2006
- Study completion
- Nov 2010 (estimated)
- First posted
- 24 Feb 2006 (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.
Patents with atrial fibrillation can be treated with the purpose of curing the arrhythmia.This may be achieved by catheter ablation and Maze surgery where the latter includes open heart surgery.
By catheter ablation the arrhythmia can be cured in about 70 % of patients who have episodes of atrial fibrillation. In patients with permanent atrial fibrillation the results are not as good.
We will compare a conventional ablation approach where lesions are created on the inside of the heart with a thoracoscopic approach where the lesions are created from the outside of the heart.
Detailed description
Patients with permanent atrial fibrillation will be considered for randomisation Patients will be randomised to either conventional endocardial catheter ablation or epicardial thoracoscopic ablation.
Objectives of study:
Primary endpoint:presence of sinus rhythm after 6 months Secondary endpoints: complications, cost-effectiveness, structural changes (evaluated by echocardiography), p-BNP and inflammatory markers, atrial fibrillation burden evaluated by Holter monitoring
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Permanent atrial fibrillation documented on at least 2 ecg´s with more than 1 month between ecg´s. The diagnosis is verified on Holter.
- All patients have symptoms or do not tolerate rate control treatment.
Key exclusion criteria (10 listed)
- Psychiatric disease or suspicion of incapability to give informed concent
- Females with birth giving potential
- Previous heart surgery
- Previous ablation for atrial fibrillation
- Life expectance less than 1 year
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 | Procedure or surgery | – |
| Thoracoscopic epicardial ablation | Procedure or surgery | – |
Primary outcome
Presence of sinus rhythm
Time frame: after 6 months from treatment
8 secondary outcomes
complications
Time frame: during 12 months from treatment
cost-effectiveness
Time frame: during 12 months from treatment
structural changes (evaluated by echocardiography)
Time frame: during 12 months from treatment
p-BNP
Time frame: during 12 months from treatment
inflammatory markers
Time frame: during 12 months from treatment
atrial fibrillation burden evaluated by Holter monitoring
Time frame: at 6 months from treatment
exercise performance
Time frame: at 3 months from treatment
Quality of life
Time frame: at 3 months from treatment
Results and safety
The study was stopped early (reason given: Patients with permanent AF are seldomly symptomatic enough to justify intervention. We decided to stop inclusion due to low recruitment rate.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2010.
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Atrial Fibrillation (AF)
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.
Jesper H Svendsen, 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 and Thoracoscopic epicardial ablation in people with Atrial Fibrillation, 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 2 inclusion and 10 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: stopped early, as of the sponsor's last update on 2 Sep 2010. 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?
The study was stopped early (reason given: Patients with permanent AF are seldomly symptomatic enough to justify intervention. We decided to stop inclusion due to low recruitment rate.). Results are not available in the source record.
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?
Presence of sinus rhythm (time frame: after 6 months from treatment). 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 2 Sep 2010.