Drug-refractory Paroxysmal Atrial FibrillationPhase 3NCT01203241
Benefit of Left Atrial Roof Ablation in Paroxysmal Atrial Fibrillation
A Phase 3 study testing Pulmonary vein encircling and Pulmonary vein encircling plus roof ablation in people with Drug-refractory Paroxysmal Atrial Fibrillation, run by Hospital Clinic of Barcelona at 1 site in Spain.
Trial summary
The aim of the present study is to assess whether left atrial roof ablation adds any benefit in the arrhythmia-free probability after paroxysmal atrial fibrillation ablation. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Drug-refractory Paroxysmal Atrial Fibrillation
- What is being tested?
- Pulmonary vein encircling and Pulmonary vein encircling plus roof ablation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteSpain
- Study dates
- Jun 2009to Dec 2012
- Phase
- Phase 3
- 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
- Drug-refractory paroxysmal atrial fibrillation
Who cannot join
- Hypo or hyperthyroidism
- Implantable defibrillation or pacemaker implanted
- Moderate or severe mitral valve disease or mitral prosthetic valve
- Ejection fraction less than 30%
- Left atrial anteroposterior diameter more than 50 mm.
- Previous atrial fibrillation ablation
Show all 15Show fewer
- Left atrium thrombus
- Current infective disease or sepsis
- Pregnant women
- Current unstable angor
- Acute myocardial infarction in last 3 months
- Atrial fibrillation secondary to ionic disturbance, thyroids disease or secondary to any other reversible or non cardiovascular disease
- Reduced expectancy of life (less than 12 months)
- Patient participating in another clinical study that investigates a drug or device
- Psychologically unstable patient or denies to give informed consent
Trial locations and contacts
1 site in 1 country.
About this study
The aim of the present study is to assess whether left atrial roof ablation adds any benefit in the arrhythmia-free probability after paroxysmal atrial fibrillation ablation.
- Being tested
- Pulmonary vein encircling, Pulmonary vein encircling plus roof ablation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulmonary vein encirclingProcedure or surgery
Pulmonary vein encircling by performing continuous radiofrequency lesions surrounding each ipsilateral pulmonary vein antrum
Pulmonary vein encircling plus roof ablationProcedure or surgery
Pulmonary vein encircling by performing continuous radiofrequency lesions surrounding each ipsilateral pulmonary vein antrum plus creation of a radiofrequency line joining contralateral superior pulmonary veins throughout the left atrial roof.
| Study group | Role | What they receive |
|---|---|---|
| Conventional ablation | Active comparator | Pulmonary vein encircling by performing continuous radiofrequency lesions surrounding each ipsilateral pulmonary vein antrum Receives: Procedure: Pulmonary vein encircling |
| Conventional ablation plus left atrial roof ablation | Active comparator | Pulmonary vein encircling by performing continuous radiofrequency lesions surrounding each ipsilateral pulmonary vein antrum plus creation of a radiofrequency line joining contralateral superior pulmonary veins throughout the left atrial roof. Receives: Procedure: Pulmonary vein encircling plus roof ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Freedom from atrial arrhythmias without antiarrhythmic drugs
Measured: 1-year follow-up
Secondary outcomes (2)
Freedom from atrial arrhythmias with or without antiarrhythmic drugs
Measured: 1-year follow-up
Presence of any complications in the acute phase or during follow-up
Measured: 1-year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2010 (estimated)
- Study startJun 2009
- Primary completionDec 2011
- Study completionDec 2012
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 Drug-refractory Paroxysmal Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Hospital Clinic of BarcelonaThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Clinic of Barcelona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Josep Lluis Mont Girbau, Hospital Clinic of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01203241
- Sponsor's protocol ID
- LARA-PAF
- Status last verified
- Dec 2013
- First submitted
- 15 Sep 2010
- Last updated
- 12 Dec 2013
- Results posted
- No
Publications
Arbelo E, Guiu E, Ramos P, Bisbal F, Borras R, Andreu D, Tolosana JM, Berruezo A, Brugada J, Mont L. Benefit of left atrial roof linear ablation in paroxysmal atrial fibrillation: a prospective, randomized study. J Am Heart Assoc. 2014 Sep 5;3(5):e000877. doi: 10.1161/JAHA.114.000877.
PubMed 25193295
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Benefit of Left Atrial Roof Ablation in Paroxysmal Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT01203241
- Acronym / sponsor ID
- LARA-PAF
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Hospital Clinic of BarcelonaUniversity, hospital or other
- Study start
- Jun 2009
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 16 Sep 2010 (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 aim of the present study is to assess whether left atrial roof ablation adds any benefit in the arrhythmia-free probability after paroxysmal atrial fibrillation ablation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional ablation | Active comparator | Procedure: Pulmonary vein encirclingPulmonary vein encircling by performing continuous radiofrequency lesions surrounding each ipsilateral pulmonary vein antrum |
| Conventional ablation plus left atrial roof ablation | Active comparator | Procedure: Pulmonary vein encircling plus roof ablationPulmonary vein encircling by performing continuous radiofrequency lesions surrounding each ipsilateral pulmonary vein antrum plus creation of a radiofrequency line joining contralateral superior pulmonary veins throughout the left atrial roof. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Drug-refractory paroxysmal atrial fibrillation
Key exclusion criteria (15 listed)
- Hypo or hyperthyroidism
- Implantable defibrillation or pacemaker implanted
- Moderate or severe mitral valve disease or mitral prosthetic valve
- Ejection fraction less than 30%
- Left atrial anteroposterior diameter more than 50 mm.
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 |
|---|---|---|
| Pulmonary vein encirclingPulmonary vein encircling by performing continuous radiofrequency lesions surrounding each ipsilateral pulmonary vein antrum | Procedure or surgery | Conventional ablation |
| Pulmonary vein encircling plus roof ablationPulmonary vein encircling by performing continuous radiofrequency lesions surrounding each ipsilateral pulmonary vein antrum plus creation of a radiofrequency line joining contralateral superior pulmonary veins throughout the left atrial roof. | Procedure or surgery | Conventional ablation plus left atrial roof ablation |
Primary outcome
Freedom from atrial arrhythmias without antiarrhythmic drugs
Time frame: 1-year follow-up
2 secondary outcomes
Freedom from atrial arrhythmias with or without antiarrhythmic drugs
Time frame: 1-year follow-up
Presence of any complications in the acute phase or during follow-up
Time frame: 1-year follow-up
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 12 Dec 2013.
- Derived from this study: PubMed 25193295Arbelo E, Guiu E, Ramos P, Bisbal F, Borras R, Andreu D, Tolosana JM, Berruezo A, Brugada J, Mont L. Benefit of left atrial roof linear ablation in paroxysmal atrial fibrillation: a prospective, randomized study. J Am Heart Assoc. 2014 Sep 5;3(5):e000877. doi: 10.1161/JAHA.114.000877.
Related trials for Drug-refractory Paroxysmal Atrial Fibrillation
Not yet recruiting
PulseMagic™ TrueForce™ PAF NMPA Study
Atrial Fibrillation (AF), Paroxysmal AF
RecruitingObservational study
The Long-term Safety and Effectiveness Evaluation of the QDOT MICRO System Use in Conjunction With VISITAG SURPOINT Module for the Treatment of Symptomatic Drug Refractory Paroxysmal Atrial Fibrillation.
Paroxysmal Atrial Fibrillation
Active, not recruiting
Treatment of PAF With the Synaptic System
Paroxysmal Atrial Fibrillation
Recruiting
Low Voltage-Directed Catheter Ablation for Atrial Fibrillation
Atrial Fibrillation - Symptomatic
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Pulmonary vein encircling and Pulmonary vein encircling plus roof ablation in people with Drug-refractory Paroxysmal Atrial Fibrillation, run by Hospital Clinic of Barcelona at 1 site in Spain.
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 15 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 12 Dec 2013. 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 Spain. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Freedom from atrial arrhythmias without antiarrhythmic drugs (time frame: 1-year follow-up). 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 NCT01203241, 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 12 Dec 2013.