Benefit of Left Atrial Roof Ablation in Paroxysmal Atrial Fibrillation
NCT ID: NCT01203241
Last Updated: 2013-12-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
120 participants
INTERVENTIONAL
2009-06-30
2012-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Conventional ablation
Pulmonary vein encircling by performing continuous radiofrequency lesions surrounding each ipsilateral pulmonary vein antrum
Pulmonary vein encircling
Pulmonary vein encircling by performing continuous radiofrequency lesions surrounding each ipsilateral pulmonary vein antrum
Conventional ablation plus left atrial roof ablation
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.
Pulmonary vein encircling plus roof ablation
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.
Interventions
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Pulmonary vein encircling
Pulmonary vein encircling by performing continuous radiofrequency lesions surrounding each ipsilateral pulmonary vein antrum
Pulmonary vein encircling plus roof ablation
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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
* 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
18 Years
75 Years
ALL
No
Sponsors
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Hospital Clinic of Barcelona
OTHER
Responsible Party
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Josep Lluis Mont Girbau
Head of the Arrhythmia Unit
Locations
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Hospital Clinic Universitari
Barcelona, Barcelona, Spain
Countries
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References
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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.
Other Identifiers
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LARA-PAF
Identifier Type: -
Identifier Source: org_study_id