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Sponsored by: |
University Hospital, Toulouse |
Information provided by: | University Hospital, Toulouse |
ClinicalTrials.gov Identifier: | NCT00259623 |
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
Condition | Intervention |
Atrial Fibrillation |
Device: Radiofrequency ablation |
Genetics Home Reference related topics: | Brugada syndrome familial atrial fibrillation short QT syndrome |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Efficacy at 3 Months on Permanent Atrial Fibrillation in Patients Candidates to Cardiac Susgical Treatment by Epicardial, or Possibly Endocardial, Radiofrequency Ablation |
Estimated Enrollment: | 40 |
Study Start Date: | December 2005 |
Estimated Study Completion Date: | December 2006 |
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:
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
For the part of the study pursued in open independant to the actual protocol, patients having signed the modified informed consent with approval of the new study procedure not yet published.
Exclusion Criteria:
Contact: Pr FOURNIAL Gérard, MD | 0561323131 ext 33 | fournial.g@chu-toulouse.fr |
France | |||||
Service de Chirurgie Cardio-Vasculaire - Hôpital Côte de Nacre | Not yet recruiting | ||||
Caen, France, 14033 | |||||
Contact: Pr KHAYAT André, MD 0231064457 ext 33 khayat-a@chu-caen.fr | |||||
Sub-Investigator: Pr KHAYAT André, MD | |||||
Sub-Investigator: Dr BABATASI Gérard, MD | |||||
Sub-Investigator: Dr MASSETTI Massimo, MD | |||||
Sub-Investigator: Dr LEPAGE Olivier, MD | |||||
Service de Chirurgie Cardio-Vasculaire - Hôpital Gabriel Montpied | Not yet recruiting | ||||
Clermont-Ferrand, France, 63003 | |||||
Contact: Pr CAMILLERI Lionel, MD 0473751579 lcamilleri@chu-clermontferrand.fr | |||||
Sub-Investigator: Pr CAMILLERI Lionel, MD | |||||
Sub-Investigator: Pr LASKAR Marc, MD | |||||
Sub-Investigator: Pr CORNU Elisabeth, MD | |||||
Sub-Investigator: Dr LE GUYADER Alexandre, MD | |||||
Sub-Investigator: Dr PESTEIL Francis, MD | |||||
Sub-Investigator: Dr SEKKAL Seïeddine, MD | |||||
Service de Chirurgie Cardio-vasculaire - CHU Dupuytren | Not yet recruiting | ||||
Limoges, France, 87042 | |||||
Contact: Pr LASKAR Marc, MD 0555056385 m.laskar@unilim.fr | |||||
Service de Chirurgie Cardio Vasculaire - Clinique Pasteur | Recruiting | ||||
Toulouse, France, 31076 | |||||
Contact: Dr SOULA Philippe, MD 0562211662 psoula@clinique-pasteur-toulouse.fr | |||||
Sub-Investigator: Dr SOULA Philippe, MD | |||||
Sub-Investigator: Dr SAUER Michel, MD | |||||
Sub-Investigator: Dr VAHDAT Olivier, MD | |||||
Service de Chirurgie Cardio Vasculaire - CHU RANGUEIL | Not yet recruiting | ||||
Toulouse, France, 31059 | |||||
Contact: Pr FOURNIAL Gérard, MD 0561322653 fournail.g@chu-toulouse.fr | |||||
Principal Investigator: Pr FOURNIAL Gérard, MD | |||||
Sub-Investigator: Pr GLOCK Yves, MD | |||||
Sub-Investigator: Dr CRON Christophe, MD | |||||
Sub-Investigator: Dr ROUX Daniel, MD |
University Hospital, Toulouse |
Principal Investigator: | Gérard FOURNIAL, MD | University Hospital Toulouse, FRANCE |
Study ID Numbers: | 0406902, AOL |
First Received: | November 25, 2005 |
Last Updated: | January 28, 2008 |
ClinicalTrials.gov Identifier: | NCT00259623 |
Health Authority: | France: Afssaps - French Health Products Safety Agency |
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