Study of Ablation Versus antiaRrhythmic Drugs in Persistent Atrial Fibrillation
NCT ID: NCT00863213
Last Updated: 2013-04-26
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
PHASE4
152 participants
INTERVENTIONAL
2009-03-31
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
NONE
Study Groups
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Atrial Fibrillation Ablation
Atrial fibrillation ablation
Atrial fibrillation ablation with radiofrequency, guided by 3D navigation map. Either 4mm or cooled tip-catheters will be used.
It will include, at least, pulmonary veins isolation; all other radiofrequency lines, including roof and mitral isthmus line, and complex fractioned electrograms ablation will be performed according to each Hospital protocol. Radiofrequency lines block will be tested.
Drug therapy
Antiarrhythmic drug
Usual drug therapy for atrial fibrillation. In patients with structural heart disease, amiodarone is recommended, while flecainide plus diltiazem or beta-blockers are encouraged in patients without structural heart diseases.
Interventions
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Atrial fibrillation ablation
Atrial fibrillation ablation with radiofrequency, guided by 3D navigation map. Either 4mm or cooled tip-catheters will be used.
It will include, at least, pulmonary veins isolation; all other radiofrequency lines, including roof and mitral isthmus line, and complex fractioned electrograms ablation will be performed according to each Hospital protocol. Radiofrequency lines block will be tested.
Antiarrhythmic drug
Usual drug therapy for atrial fibrillation. In patients with structural heart disease, amiodarone is recommended, while flecainide plus diltiazem or beta-blockers are encouraged in patients without structural heart diseases.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Persistent atrial fibrillation lasting more than 1 year or non-defined duration
* Hypertrophic myocardiopathy
* 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
* Contraindication to anticoagulation
* 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
* Any cause that contraindicate ablation procedure or antiarrhythmic drug
18 Years
70 Years
ALL
No
Sponsors
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Medtronic
INDUSTRY
Fundacio Clinic Barcelona
OTHER
Biosense Webster, Inc.
INDUSTRY
Hospital Clinic of Barcelona
OTHER
Responsible Party
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Josep Lluis Mont Girbau
MD Phd
Principal Investigators
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Lluís Mont, MD
Role: STUDY_CHAIR
Hospital Clinic of Barcelona
Angel Arenal, MD
Role: STUDY_DIRECTOR
Hospital Gregorio Marañon
Julian Villacastin, MD
Role: STUDY_DIRECTOR
Hospital San Carlos, Madrid
Josep Brugada, prof Md. PHD
Role: STUDY_DIRECTOR
Hospital Clinic of Barcelona
Locations
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Hospital Clinic Universitari
Barcelona, Barcelona, Spain
Hospital de Sant Pau
Barcelona, Barcelona, Spain
Hospital de Cruces
Bilbao, Bizkaia, Spain
Clínica Puerta de Hierro
Madrid, Madrid, Spain
Hospital 12 de Octubre
Madrid, Madrid, Spain
Hospital Clínico San Carlos
Madrid, Madrid, Spain
Hospital Gregorio Marañon
Madrid, Madrid, Spain
Hospital Ramón y Cajal
Madrid, Madrid, Spain
Countries
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References
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Mont L, Bisbal F, Hernandez-Madrid A, Perez-Castellano N, Vinolas X, Arenal A, Arribas F, Fernandez-Lozano I, Bodegas A, Cobos A, Matia R, Perez-Villacastin J, Guerra JM, Avila P, Lopez-Gil M, Castro V, Arana JI, Brugada J; SARA investigators. Catheter ablation vs. antiarrhythmic drug treatment of persistent atrial fibrillation: a multicentre, randomized, controlled trial (SARA study). Eur Heart J. 2014 Feb;35(8):501-7. doi: 10.1093/eurheartj/eht457. Epub 2013 Oct 17.
Other Identifiers
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EudraCT: 2008-006095-30
Identifier Type: -
Identifier Source: secondary_id
SARA-08
Identifier Type: -
Identifier Source: org_study_id
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