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

Primary Purpose

Atrial Fibrillation

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Radiofrequency ablation
Sponsored by
University Hospital, Toulouse
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Fibrillation focused on measuring Cardiac surgery, Radiofrequency ablation, Atrial fibrillation

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Service de Chirurgie Cardio-Vasculaire - Hôpital Côte de Nacre
  • Service de Chirurgie Cardio-Vasculaire - Hôpital Gabriel Montpied
  • Service de Chirurgie Cardio-vasculaire - CHU Dupuytren
  • Service de Chirurgie Cardio Vasculaire - CHU RANGUEIL
  • Service de Chirurgie Cardio Vasculaire - Clinique Pasteur

Outcomes

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

Secondary Outcome Measures

Full Information

First Posted
November 25, 2005
Last Updated
July 16, 2009
Sponsor
University Hospital, Toulouse
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1. Study Identification

Unique Protocol Identification Number
NCT00259623
Brief Title
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

2. Study Status

Record Verification Date
July 2009
Overall Recruitment Status
Completed
Study Start Date
December 2005 (undefined)
Primary Completion Date
October 2007 (Actual)
Study Completion Date
October 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University Hospital, Toulouse

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
Cardiac surgery, Radiofrequency ablation, Atrial fibrillation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
13 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
Radiofrequency ablation
Primary Outcome Measure Information:
Title
- absence of atrial fibrillation at 3 months.
Title
The patients presenting a spontaneous sinus rhythm heart rate or who need a permanent pace maker at 3 months will be considered as SUCCESSFUL.
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gérard FOURNIAL, MD
Organizational Affiliation
University Hospital, Toulouse, France
Official's Role
Principal Investigator
Facility Information:
Facility Name
Service de Chirurgie Cardio-Vasculaire - Hôpital Côte de Nacre
City
Caen
ZIP/Postal Code
14033
Country
France
Facility Name
Service de Chirurgie Cardio-Vasculaire - Hôpital Gabriel Montpied
City
Clermont-Ferrand
ZIP/Postal Code
63003
Country
France
Facility Name
Service de Chirurgie Cardio-vasculaire - CHU Dupuytren
City
Limoges
ZIP/Postal Code
87042
Country
France
Facility Name
Service de Chirurgie Cardio Vasculaire - CHU RANGUEIL
City
Toulouse
ZIP/Postal Code
31059
Country
France
Facility Name
Service de Chirurgie Cardio Vasculaire - Clinique Pasteur
City
Toulouse
ZIP/Postal Code
31076
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
12400744
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.
Results Reference
background
PubMed Identifier
12440600
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.
Results Reference
result

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

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