The objective of the study is to evaluate the efficacy of the epicardial or endocardial radiofrequency ablation in the treatment of atrial fibrillation. It is a multicentric, prospective, randomized, parallel, comparative, double blind study. The study principal objective is to evaluate the absence of atrial fibrillation after 3 months. The secondary objectives consist in the evaluation of the maintenance of the sinusal heart rate at one year and of the quality of life improvement
Principal objective: To evaluate the efficacy at 3 months of combined ablation technique in the treatment of chronic atrial fibrillation during cardiac surgery in order to obtain a sinusal heart rate. A sequential statistical analysis of the results will be performed every 10 patients. In case of validation of the principal objective by a sequential method i.e. proving the superiority of the treatment by ablation, ,the study would then be opened and pursued by using the ablation technique for all subsequent patients in order to validate the secondary study objectives Secondary objectives: * To evaluate the quality of life of the patients at one year and the absence of atrial fibrillation relapse. * 6 and 12 months clinical follow-up * To evaluate the left atrial function at 6 months by trans-oesophagus echocardiography
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
13
Service de Chirurgie Cardio-Vasculaire - Hôpital Côte de Nacre
Caen, CAEN, France
Service de Chirurgie Cardio-Vasculaire - Hôpital Gabriel Montpied
Clermont-Ferrand, Clermont-ferrand, France
Service de Chirurgie Cardio-vasculaire - CHU Dupuytren
Limoges, Limoges, France
Service de Chirurgie Cardio Vasculaire - CHU RANGUEIL
Toulouse, Toulouse, France
- absence of atrial fibrillation at 3 months.
The patients presenting a spontaneous sinus rhythm heart rate or who need a permanent pace maker at 3 months will be considered as SUCCESSFUL.
The patients presenting at 3 months either an atrial fibrillation or a left flutter despite an adapted anti-arrythmia treatment and one electric cardioversion,and the patients who died before the 3 months evaluation will be considered as FAILURES
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Service de Chirurgie Cardio Vasculaire - Clinique Pasteur
Toulouse, Toulouse, France