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|---|---|---|---|
| AOL |
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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:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radiofrequency ablation | Device |
| Measure | Description | Time Frame |
|---|---|---|
| - 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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Inclusion Criteria:
For the part of the study pursued in open independent to the actual protocol, patients having signed the modified informed consent with approval of the new study procedure not yet published.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gérard FOURNIAL, MD | University Hospital, Toulouse, France | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Service de Chirurgie Cardio-Vasculaire - Hôpital Côte de Nacre | Caen | CAEN | 14033 | France | ||
| Service de Chirurgie Cardio-Vasculaire - Hôpital Gabriel Montpied |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12400744 | Background | Benussi S, Nascimbene S, Agricola E, Calori G, Calvi S, Caldarola A, Oppizzi M, Casati V, Pappone C, Alfieri O. Surgical ablation of atrial fibrillation using the epicardial radiofrequency approach: mid-term results and risk analysis. Ann Thorac Surg. 2002 Oct;74(4):1050-6; discussion 1057. doi: 10.1016/s0003-4975(02)03850-x. | |
| 12440600 |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D000078703 | Radiofrequency Ablation |
| ID | Term |
|---|---|
| D000078702 | Radiofrequency Therapy |
| D013812 | Therapeutics |
| D055011 | Ablation Techniques |
| D013514 | Surgical Procedures, Operative |
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| Clermont-Ferrand |
| Clermont-ferrand |
| 63003 |
| France |
| Service de Chirurgie Cardio-vasculaire - CHU Dupuytren | Limoges | Limoges | 87042 | France |
| Service de Chirurgie Cardio Vasculaire - CHU RANGUEIL | Toulouse | Toulouse | 31059 | France |
| Service de Chirurgie Cardio Vasculaire - Clinique Pasteur | Toulouse | Toulouse | 31076 | France |
| Raman JS, Ishikawa S, Power JM. Epicardial radiofrequency ablation of both atria in the treatment of atrial fibrillation: experience in patients. Ann Thorac Surg. 2002 Nov;74(5):1506-9. doi: 10.1016/s0003-4975(02)03945-0. |
| D013568 |
| Pathological Conditions, Signs and Symptoms |