Cardiac Surgical Treatment by Radiofrequency Ablation on Valvular Patients: Efficacy at 3 Months
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
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||Efficacy at 3 Months on Permanent Atrial Fibrillation in Patients Candidates to Cardiac Surgical Treatment by Epicardial, or Possibly Endocardial, Radiofrequency Ablation|
- - 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
|Study Start Date:||December 2005|
|Study Completion Date:||October 2007|
|Primary Completion Date:||October 2007 (Final data collection date for primary outcome measure)|
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
- 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00259623
|Service de Chirurgie Cardio-Vasculaire - Hôpital Côte de Nacre|
|Caen, France, 14033|
|Service de Chirurgie Cardio-Vasculaire - Hôpital Gabriel Montpied|
|Clermont-Ferrand, France, 63003|
|Service de Chirurgie Cardio-vasculaire - CHU Dupuytren|
|Limoges, France, 87042|
|Service de Chirurgie Cardio Vasculaire - Clinique Pasteur|
|Toulouse, France, 31076|
|Service de Chirurgie Cardio Vasculaire - CHU RANGUEIL|
|Toulouse, France, 31059|
|Principal Investigator:||Gérard FOURNIAL, MD||University Hospital Toulouse, FRANCE|