Clinical trial NCT00259623: Cardiac Surgical Treatment by Radiofrequency Ablation on Valvular Patients: Efficacy at 3 Months
Official title: Efficacy at 3 Months on Permanent Atrial Fibrillation in Patients Candidates to Cardiac Surgical Treatment by Epicardial, or Possibly Endocardial, Radiofrequency Ablation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation
Keywords: Cardiac surgery
Radiofrequency ablation
Atrial fibrillation
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2005-11-29
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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

Detailed description: 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

Eligibility criteria: Inclusion Criteria:

* Adult patients with no age limit, presenting a chronic atrial fibrillation and planned to undergo a surgical intervention on mitral valve (valve replacement or plasty) associated or not with myocardial revascularization or replacement/plasty of another valve (aortic, tricuspid)
* The chronic atrial fibrillation is defined as a continuous atrial fibrillation more than 1 month before the surgery despite all anti-arrhythmia treatments including cardioversion ; the atrial fibrillation can be associated to another rhythm trouble except the severe ventricular rhythm troubles.
* The indication for surgery is performed using the clinical evaluation : NYHA \>2 and the usual echocardiography criteria (mitral regurgitation \> grade 3, mitral gradient \>10 mm Hg or valve surface \< 1,5 cm2)
* Patients with a vital prognosis not compromised by comorbidity in the next 2 years and with a mental state enabling to give informed consent
* Patients agreeing to take part in the study and having signed the informed consent form.

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:

* Paroxystic atrial fibrillation or atrial fibrillation for less than 1 month
* Atrial fibrillation never treated by cardioversion or pharmacology before surgery.
* Contra-indication to surgery, i.e. severe respiratory failures, multivisceral deficiencies (renal, cardiac or hepatic), rapidly evolutive or metastatic cancers, malignant hemopathies not stabilized by chemotherapy
* Contra-indication to the following arrhythmia treatments: class III (amiodarone) associated to contra-indication to class II (beta blockers) or to class Ic (flecainide, propafenone, cibenzoline).
* Severe decompensated heart failure.
* Uncontrolled, repetitive, severe documented ventricular arrhythmia (ventricular tachycardia, ventricular fibrillation episodes)
* Contra indication to epicardic ablation procedure (pericardic adhesions, intra-atrial thrombus) In these cases the ablation could be only an endocardic ablation but it does not necessarily exclude the patient.
* Ventricular "ejection fraction " \< 40%
* Impossibility to follow the pre-inclusion phases i.e. emergency surgery for mitral break or evolutive endocarditis.
* Patients with disabled mental status
* Patient participating in another clinical study

Primary outcomes:
measure: - absence of atrial fibrillation at 3 months.
measure: The patients presenting a spontaneous sinus rhythm heart rate or who need a permanent pace maker at 3 months will be considered as SUCCESSFUL.
measure: 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
Secondary outcomes:
Other outcomes:
Locations:
city: Caen
country: France
facility: Service de Chirurgie Cardio-Vasculaire - Hôpital Côte de Nacre
city: Clermont-Ferrand
country: France
facility: Service de Chirurgie Cardio-Vasculaire - Hôpital Gabriel Montpied
city: Limoges
country: France
facility: Service de Chirurgie Cardio-vasculaire - CHU Dupuytren
city: Toulouse
country: France
facility: Service de Chirurgie Cardio Vasculaire - CHU RANGUEIL
city: Toulouse
country: France
facility: Service de Chirurgie Cardio Vasculaire - Clinique Pasteur
Study officials:
affiliation: University Hospital, Toulouse, France
name: Gérard FOURNIAL, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.