The purpose of this study is to compare the effectivity and safety of atrial fibrillation ablation, in comparison to antiarrhythmic drug therapy in patients with refractory, persistent atrial fibrillation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
152
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.
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.
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
Freedom from atrial arrhythmias, lasting more than 24 hours or requiring cardioversion.
Time frame: 1-year follow-up
Freedom from atrial arrhythmias (lasting more than 30 seconds) without antiarrhythmic drugs.
Time frame: 1-year follow-up
Decrease in frequency and duration of atrial fibrillation or atrial flutter recurrences.
Time frame: 1-year follow-up
Decrease in atrial fibrillation/atrial flutter related hospital admissions
Time frame: 1-year follow-up
Improve in quality of life measured with standard questionary for Atrial Fibrillation: AF-QoL.
Time frame: 1-year follow-up
Change in need of cardioversions
Time frame: From 3rd to 12th months
Need of atrio-ventricular node ablation
Time frame: 1-year follow-up
Need of crossover to the other arm of the study (only when primary end point has been reached)
Time frame: 1-year follow-up
Need of a new intervention or ablation during blanking period
Time frame: Until 3rd month
Detection of asymptomatic episodes by Reveal XT
Time frame: 1-year follow-up
Presence of any complications in the acute phase or during follow-up
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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
Time frame: 1-year follow-up