NAVISTARÂ® THERMOCOOLÂ® Catheter for the Treatment of Atrial Fibrillation
This trial compares the safety and effectiveness of catheter ablation for PAF with antiarrhythmic drug therapy. The investigational catheter being studied is the NAVISTAR® THERMOCOOL® irrigated-tip catheter. It is currently FDA-approved for commercial distribution in the U.S. for treating patients with Type I atrial flutter and drug refractory Ventricular Tachycardia for MI patients. The catheter is approved for use in Europe for endocardial ablation for treating cardiac arrhythmias.
This is a prospective, randomized, open-label, active-control trial that will enroll up to 230 participants at up to 30 hospitals in the U.S. Patients will be randomized using a 2:1 scheme for the test procedure (ablation)and control (medical therapy) groups, respectively. Patients who fail the trial medication may have an RF ablation procedure according to protocol.
We're trying to improve treatment for atrial fibrillation - you can help!
Do you have episodes of chest pain, palpitations or fainting? This may be due to a condition called "Paroxysmal Atrial Fibrillation". If drug therapy has not been successful to treat this condition or you have intolerable side effects due to medications you are currently taking to treat this condition, you may be eligible for this trial.
What is being studied?
This clinical trial is comparing the safety and effectiveness of a non-drug treatment (medical device) called catheter ablation with the standard drug therapy for AFib. This study is evaluating whether a particular investigational ablation catheter can be used safely and effectively to treat paroxysmal atrial fibrillation.
What does the treatment consist of?
In this procedure, thin flexible tubes (catheters) are inserted into a vein in the groin and threaded into the heart. An attachment at the tip of the catheter delivers electrical energy to the heart tissue. This results in a small, localized burn which modifies the areas of heart muscle essential for starting or maintaining the atrial fibrillation.
Is this treatment dangerous?
All interventional treatments have risks. However, this procedure is widely used for other types of heart rhythm disorders in the U.S. and worldwide with low complication rates. The treatment of paroxysmal atrial fibrillation is a new indication for this particular catheter. Which is why it is the subject of a clinical trial.
I've already failed drug therapy. Can I be in the catheter ablation treatment group?
In order to approve a new treatment, the government requires that "randomized" clinical trials be conducted, comparing the new treatment with the standard of care at the time. In this trial, approximately two-thirds of the patients will receive the ablation treatment, while the remaining patients will be given an antiarrhythmic medication. Those who receive the medication may be eligible to have the ablation treatment at a later date.
Why would I want to take part in this trial?
Currently in the U.S., AFib is primarily treated with drug therapy. But about half of patients treated with antiarrhythmic drugs fail to achieve relief from AFib or find the side effects of the drugs intolerable. The purpose of the study is to demonstrate whether catheter ablation is safe and effective for treating AFib. You would therefore be helping to advance knowledge about the treatment of patients like yourself who have AFib and who are either not getting relief from medications or are unduly bothered by the drug's side effects.
Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
NAVISTAR® THERMOCOOL® catheter
Arizona Arrhythmia Consultants
Active, not recruiting
Biosense Webster, Inc.
Results (where available)
- Source: http://clinicaltrials.gov/show/NCT00116428
- Information obtained from ClinicalTrials.gov on July 15, 2010
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Medical and Biotech [MESH] Definitions
Occlusion of the outflow tract in either the LEFT VENTRICLE or the RIGHT VENTRICLE of the heart. This may result from CONGENITAL HEART DEFECTS, predisposing heart diseases, complications of surgery, or HEART NEOPLASMS.
Pathological conditions involving the HEART including its structural and functional abnormalities.
A voluntary organization concerned with the prevention and treatment of heart and vascular diseases.
Inflammation of the ENDOCARDIUM caused by BACTERIA that entered the bloodstream. The strains of bacteria vary with predisposing factors, such as CONGENITAL HEART DEFECTS; HEART VALVE DISEASES; HEART VALVE PROSTHESIS IMPLANTATION; or intravenous drug use.
Infections resulting from the use of catheters. Proper aseptic technique, site of catheter placement, material composition, and virulence of the organism are all factors that can influence possible infection.