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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00259623
• Date of registration: 25/11/2005
• Prospective Registration: Yes
• Primary sponsor: University Hospital, Toulouse
• Public title: Cardiac Surgical Treatment by Radiofrequency Ablation on Valvular Patients: Efficacy at 3 Months
• Scientific title: Efficacy at 3 Months on Permanent Atrial Fibrillation in Patients Candidates to Cardiac Surgical Treatment by Epicardial, or Possibly Endocardial, Radiofrequency Ablation
• Date of first enrolment: December 2005
• Target sample size: 13
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00259623
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
• Phase: N/A

Countries of recruitment

France

Contacts

• Name: Gérard FOURNIAL, MD
• Affiliation: University Hospital Toulouse, FRANCE

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 80 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Atrial Fibrillation

Intervention(s)

Device: Radiofrequency ablation

Primary Outcome(s)

- 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 ID(s)

AOL

0406902

Source(s) of Monetary Support

Please refer to primary and secondary sponsors