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

NCT00259623 | Completed

• 2 other identifiers: 0406902AOL
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 5

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

Conditions

Atrial Fibrillation

Keywords

Cardiac surgery; Radiofrequency ablation; Atrial fibrillation

Outcome Measures

Primary Outcomes (3)

• - 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

Interventions

Radiofrequency ablation DEVICE

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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%
• Patients with disabled mental status
• Patient participating in another clinical study

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (5)

Service de Chirurgie Cardio-Vasculaire - Hôpital Côte de Nacre

Caen, CAEN, 14033, France

Location

Service de Chirurgie Cardio-Vasculaire - Hôpital Gabriel Montpied

Clermont-Ferrand, Clermont-ferrand, 63003, France

Location

Service de Chirurgie Cardio-vasculaire - CHU Dupuytren

Limoges, Limoges, 87042, France

Location

Service de Chirurgie Cardio Vasculaire - CHU RANGUEIL

Toulouse, Toulouse, 31059, France

Location

Service de Chirurgie Cardio Vasculaire - Clinique Pasteur

Toulouse, Toulouse, 31076, France

Location

Related Publications (2)

• 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.

  PMID: 12400744 BACKGROUND

• 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.

  PMID: 12440600 RESULT

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Radiofrequency Ablation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Study Officials

• Gérard FOURNIAL, MD

  University Hospital, Toulouse, France

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 25, 2005
• First Posted: November 29, 2005
• Study Start: December 1, 2005
• Primary Completion: October 1, 2007
• Study Completion: October 1, 2007
• Last Updated: July 17, 2009

Record last verified: 2009-07

Locations

FR (5)