Cardiac Surgical Treatment by Radiofrequency Ablation on Valvular Patients : Efficacy at 3 Months - Full Text View

Sponsored by:	University Hospital, Toulouse
Information provided by:	University Hospital, Toulouse
ClinicalTrials.gov Identifier:	NCT00259623

Purpose

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

U.S. FDA Resources

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

Further study details as provided by University Hospital, Toulouse:

Primary Outcome Measures:

- 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 antiarythmia treatment and one electric cardioversion,and the patients who died before the 3 months evaluation will be considered as FAILURES

Estimated Enrollment:	40
Study Start Date:	December 2005
Estimated Study Completion Date:	December 2006

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

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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 revascularisation 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 antiarythmia 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 compromized by comorbity 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 independant 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), rapidely evolutive or metastatic cancers, malignant hemopathies not stabilised by chemotherapy
Contra-indication to the following arythmia 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 arythmia (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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00259623

Contacts

Contact: Pr FOURNIAL Gérard, MD

0561323131 ext 33

fournial.g@chu-toulouse.fr

Locations

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

Sponsors and Collaborators

University Hospital, Toulouse

Investigators

Principal Investigator:

Gérard FOURNIAL, MD

University Hospital Toulouse, FRANCE

More Information

Publications of Results:

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.

Other Publications:

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.

Study ID Numbers:	0406902, AOL
Study First Received:	November 25, 2005
Last Updated:	January 28, 2008
ClinicalTrials.gov Identifier:	NCT00259623
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by University Hospital, Toulouse:

Cardiac surgery
Radiofrequency ablation
Atrial fibrillation

Study placed in the following topic categories:

Heart Diseases
Atrial Fibrillation
Arrhythmias, Cardiac

Additional relevant MeSH terms:

Pathologic Processes
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 14, 2009