Atrial FibrillationNCT00192972
A Randomized Trial of the Ostial Versus the Extra-Ostial Ablation Strategy for Atrial Fibrillation
A study testing Catheter ablation (pulmonary vein isolation) in people with Atrial Fibrillation and Arrhythmia, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
Both segmental, ostial and circumferential, extra-ostial pulmonary vein (PV) isolation have been proven effective in the treatment of atrial fibrillation. In this study patients with symptomatic paroxystic or persistent AF were randomised to one of the above mentioned ablation methods. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation, Arrhythmia
- What is being tested?
- Catheter ablation (pulmonary vein isolation)
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteDenmark
- Study dates
- Nov 2002to Jun 2005
- 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
- symptomatic paroxysmal or persistent AF for more than 6 months, with at least 3 episodes in 3 months and with insufficient effect of at least 2 pharmacological regimens
Who cannot join
- congenital heart disease
- age under 18 years
- significant valve disease
- left atrial size > 55 mm
- prior ablation for AF
- Severe heart failure (LVEF < 20 % and/or NYHA class IV)
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Righospitalet, Copenhagen University Hospital
Copenhagen, DK-2199
About this study
Official title: A Randomized Trial of the Ostial Versus the Extra-Ostial Ablation Strategy for Atrial Fibrillation (LASso Vs CARto)
Both segmental, ostial and circumferential, extra-ostial pulmonary vein (PV) isolation have been proven effective in the treatment of atrial fibrillation.
In this study patients with symptomatic paroxystic or persistent AF were randomised to one of the above mentioned ablation methods. The primary endpoints were recurrent AF and recurrence of left atrium-PV conduction.
Read the detailed description
Both segmental, ostial and circumferential, extra-ostial pulmonary vein (PV) isolation have been proven effective in the treatment of atrial fibrillation.
In this study with symptomativ paroxystic or persistent AF were randomised to one of the above mentioned ablation methods. Each patient was allowed a maximum of two ablation procedures. Holter monitoring for 14-days periods will be performed at 3 months after ablation. The patiens are seen at out-patient visits at 1, 3, 6, 9, and 12 months after the ablation procedure.
Primary endpoints were recurrent AF and recurrence of left atrium-PV conduction.
Secondary endpoints were:
- safety
- resumption of LA-PV conduction
- alterations in neurohormones
- socio-economics aspects(cost effectiveness)
- changes in inflammatory markers
- quality of life
- alterations in signal averaged P wawe signals
- evaluation of the predictive value of these variables to predict recurrence of AF
- Conditions
- Atrial Fibrillation, Arrhythmia
- Being tested
- Catheter ablation (pulmonary vein isolation)
- Keywords
- Catheter ablation, Atrial fibrillation
- 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 ablation (pulmonary vein isolation)Procedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
overall efficacy (= freedom from symptomatic, ECG documented AF or organized LA tachycardia (with a duration of > 10 min) without receiving antiarrhythmic medication)
Secondary outcomes (7)
- safety
- resumption of LA-PV conduction
- neurohormones
- socio-economics (cost effectiveness)
- inflammatory markers
- quality of life
- signal averaged P wave signals-
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2005 (estimated)
- Study startNov 2002
- Study completionJun 2005
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 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
- Early clinical test
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic, Biosense Webster, Inc., Abbott Medical Devices, Guidant Corporation
- Investigators
- Brian Nilsson, MD, Principal investigator, Copenhagen University Hospital, RigshospitaletXu Chen, MD, Principal investigator, Righospitalet, Copenhagen, DenmarkSteen M Pehrson, MD, Principal investigator, Righospitalet, Copenhagen, DenmarkLars Køber, MD, Principal investigator, Righospitalet, Copenhagen, DenmarkJørgen Hilden, MD, Principal investigator, Department of biostatistics, University of CopenhagenJesper H Svendsen, MD, Principal investigator, Righospitalet, Copenhagen, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00192972
- Sponsor's protocol ID
- LASCAR
- Status last verified
- Nov 2003
- First submitted
- 12 Sep 2005
- Last updated
- 22 Dec 2005
- Results posted
- No
Publications
Oral H, Chugh A, Lemola K, Cheung P, Hall B, Good E, Han J, Tamirisa K, Bogun F, Pelosi F Jr, Morady F. Noninducibility of atrial fibrillation as an end point of left atrial circumferential ablation for paroxysmal atrial fibrillation: a randomized study. Circulation. 2004 Nov 2;110(18):2797-801. doi: 10.1161/01.CIR.0000146786.87037.26. Epub 2004 Oct 25.
PubMed 15505091
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial of the Ostial Versus the Extra-Ostial Ablation Strategy for Atrial Fibrillation (LASso Vs CARto)
- ClinicalTrials.gov ID
- NCT00192972
- Acronym / sponsor ID
- LASCAR
- Conditions
- Atrial Fibrillation, Arrhythmia
- Keywords
- Catheter ablation, Atrial fibrillation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Collaborators
- Medtronic, Biosense Webster, Inc., Abbott Medical Devices, Guidant Corporation
- Study start
- Nov 2002
- Study completion
- Jun 2005
- First posted
- 19 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.
Both segmental, ostial and circumferential, extra-ostial pulmonary vein (PV) isolation have been proven effective in the treatment of atrial fibrillation.
In this study patients with symptomatic paroxystic or persistent AF were randomised to one of the above mentioned ablation methods. The primary endpoints were recurrent AF and recurrence of left atrium-PV conduction.
Detailed description
Both segmental, ostial and circumferential, extra-ostial pulmonary vein (PV) isolation have been proven effective in the treatment of atrial fibrillation.
In this study with symptomativ paroxystic or persistent AF were randomised to one of the above mentioned ablation methods. Each patient was allowed a maximum of two ablation procedures. Holter monitoring for 14-days periods will be performed at 3 months after ablation. The patiens are seen at out-patient visits at 1, 3, 6, 9, and 12 months after the ablation procedure.
Primary endpoints were recurrent AF and recurrence of left atrium-PV conduction.
Secondary endpoints were:
- safety
- resumption of LA-PV conduction
- alterations in neurohormones
- socio-economics aspects(cost effectiveness)
- changes in inflammatory markers
- quality of life
- alterations in signal averaged P wawe signals
- evaluation of the predictive value of these variables to predict recurrence of AF
Study design
- Primary purpose
- Early clinical test
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- symptomatic paroxysmal or persistent AF for more than 6 months, with at least 3 episodes in 3 months and with insufficient effect of at least 2 pharmacological regimens
Key exclusion criteria (6 listed)
- congenital heart disease
- age under 18 years
- significant valve disease
- left atrial size > 55 mm
- prior ablation for AF
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 (pulmonary vein isolation) | Procedure or surgery | – |
Primary outcome
overall efficacy (= freedom from symptomatic, ECG documented AF or organized LA tachycardia (with a duration of > 10 min) without receiving antiarrhythmic medication)
7 secondary outcomes
- safety
- resumption of LA-PV conduction
- neurohormones
- socio-economics (cost effectiveness)
- inflammatory markers
- quality of life
- signal averaged P wave signals-
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 22 Dec 2005.
- Background: PubMed 15505091Oral H, Chugh A, Lemola K, Cheung P, Hall B, Good E, Han J, Tamirisa K, Bogun F, Pelosi F Jr, Morady F. Noninducibility of atrial fibrillation as an end point of left atrial circumferential ablation for paroxysmal atrial fibrillation: a randomized study. Circulation. 2004 Nov 2;110(18):2797-801. doi: 10.1161/01.CIR.0000146786.87037.26. Epub 2004 Oct 25.
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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.
Brian Nilsson, MD principal investigator
Copenhagen University Hospital, Rigshospitalet
Xu Chen, MD principal investigator
Righospitalet, Copenhagen, Denmark
Steen M Pehrson, MD principal investigator
Righospitalet, Copenhagen, Denmark
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 (pulmonary vein isolation) in people with Atrial Fibrillation and Arrhythmia, 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 1 inclusion and 6 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 22 Dec 2005. 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 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?
overall efficacy (= freedom from symptomatic, ECG documented AF or organized LA tachycardia (with a duration of > 10 min) without receiving antiarrhythmic medication). 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 NCT00192972, 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 22 Dec 2005.