Atrial Fibrillation Clinical Trial
Official title:
Efficacy at 3 Months on Permanent Atrial Fibrillation in Patients Candidates to Cardiac Surgical Treatment by Epicardial, or Possibly Endocardial, Radiofrequency Ablation
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
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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