Cardiac Surgical Treatment by Radiofrequency Ablation on Valvular Patients: Efficacy at 3 Months
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
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
Study Design
Allocation: Randomized, Control: Active Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Conditions
Atrial Fibrillation
Intervention
Radiofrequency ablation
Location
Service de Chirurgie Cardio-Vasculaire - Hôpital Côte de Nacre
Caen
France
14033
Status
Completed
Source
University Hospital, Toulouse
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00259623
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Atrial Flutter
Rapid, irregular atrial contractions caused by a block of electrical impulse conduction in the right atrium and a reentrant wave front traveling up the inter-atrial septum and down the right atrial free wall or vice versa. Unlike ATRIAL FIBRILLATION which is caused by abnormal impulse generation, typical atrial flutter is caused by abnormal impulse conduction. As in atrial fibrillation, patients with atrial flutter cannot effectively pump blood into the lower chambers of the heart (HEART VENTRICLES).
Digoxin
A cardiotonic glycoside obtained mainly from Digitalis lanata; it consists of three sugars and the aglycone DIGOXIGENIN. Digoxin has positive inotropic and negative chronotropic activity. It is used to control ventricular rate in ATRIAL FIBRILLATION and in the management of congestive heart failure with atrial fibrillation. Its use in congestive heart failure and sinus rhythm is less certain. The margin between toxic and therapeutic doses is small. (From Martindale, The Extra Pharmacopoeia, 30th ed, p666)
Warfarin
An anticoagulant that acts by inhibiting the synthesis of vitamin K-dependent coagulation factors. Warfarin is indicated for the prophylaxis and/or treatment of venous thrombosis and its extension, pulmonary embolism, and atrial fibrillation with embolization. It is also used as an adjunct in the prophylaxis of systemic embolism after myocardial infarction. Warfarin is also used as a rodenticide.
Ablation Techniques
Removal of tissue by vaporization, abrasion, or destruction. Methods used include heating tissue by hot liquids or microwave thermal heating, freezing (CRYOABLATION), chemical ablation, and photoablation with LASERS.
Atrial Premature Complexes
A type of cardiac arrhythmia with premature atrial contractions or beats caused by signals originating from ectopic atrial sites. The ectopic signals may or may not conduct to the HEART VENTRICLES. Atrial premature complexes are characterized by premature P waves on ECG which are different in configuration from the P waves generated by the normal pacemaker complex in the SINOATRIAL NODE.
Clinical Trials
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PubMed Articles
Catheter ablation for paroxysmal atrial fibrillation is a meanwhile established therapy option, which is most frequently performed using radiofrequency ablation. Mid-term success rate of 70 % are ac...
Radiofrequency ablation as initial therapy in paroxysmal atrial fibrillation.
There are limited data comparing radiofrequency catheter ablation with antiarrhythmic drug therapy as first-line treatment in patients with paroxysmal atrial fibrillation.
The purpose of this study was to evaluate the feasibility, safety, and outcomes of radiofrequency ablation of atrial fibrillation (AF) in patients with mechanical mitral valve replacement (MVR).
Prevention of esophageal thermal injury during radiofrequency ablation for atrial fibrillation.
Pulmonary vein isolation using radiofrequency ablation is an effective therapy in patients with atrial fibrillation. However, the esophagus descends in close proximity to the posterior wall of the lef...
Atrial fibrillation is the most common arrhythmia in the United States. Procedural treatment options such as the MAZE procedure and radiofrequency ablation are available with reasonable success rates....
