Cardiac Surgical Treatment by Radiofrequency Ablation on Valvular Patients: Efficacy at 3 Months

This study has been completed.
Sponsor:
Information provided by:
University Hospital, Toulouse
ClinicalTrials.gov Identifier:
NCT00259623
First received: November 25, 2005
Last updated: July 16, 2009
Last verified: July 2009
  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

Study Type: Interventional
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

Resource links provided by NLM:


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

Enrollment: 13
Study Start Date: December 2005
Study Completion Date: October 2007
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
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 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
France
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
Sponsors and Collaborators
University Hospital, Toulouse
Investigators
Principal Investigator: Gérard FOURNIAL, MD University Hospital Toulouse, FRANCE
  More Information

Publications:
Responsible Party: Roques, University Hospital Toulouse
ClinicalTrials.gov Identifier: NCT00259623     History of Changes
Other Study ID Numbers: 0406902, AOL
Study First Received: November 25, 2005
Last Updated: July 16, 2009
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Toulouse:
Cardiac surgery
Radiofrequency ablation
Atrial fibrillation

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on September 22, 2014