Track topics on Twitter Track topics that are important to you
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.
Published on BioPortfolio: 2014-08-27T03:53:05-0400
This trial evaluates the safety and effectiveness of catheter ablation for PAF. The investigational catheter being studied is the NAVISTAR® THERMOCOOL® irrigated-tip catheter. It is cur...
This is a prospective, interventional, observational, unblinded, single-arm, multicenter registry of younger and older subjects with drug refractory, recurrent, symptomatic paroxysmal atri...
The primary objective is to provide additional corroborative safety and efficacy data for the Navistar ThermoCool catheter for the treatment of subjects with ischemic Ventricular Tachycard...
This is a prospective, multicenter, non-randomized clinical evaluation utilizing the THERMOCOOL SMARTTOUCH® SF catheter compared to a predetermined performance goal.
To demonstrate safety and effectiveness of nMARQ Catheter System [nMARQ] compared with THERMOCOOL® Navigational Family of catheters in treating subjects with drug-refractory symptomatic p...
Right heart catheter advancement from right atrium (RA) to right ventricle (RV) is frequently difficult in patients with large and geometrically deformed RAs. We describe a simple technique, using no ...
Long-term hemodialysis catheter dwell time in the central vein predisposes to fibrin sheath development, which subsequently causes catheter malfunction or occlusion. In very rare cases, the catheter c...
Due to the demographic change, chronic valvular heart disease becomes increasingly important - especially age-related primary diseases of the aortic and mitral valve as well as secondary diseases of t...
The extracardiac total cavopulmonary connection (E-TCPC) is widely performed for single ventricle palliation, yet there is little experience with catheter ablation in this population.
Heart failure (HF) and ischemic heart diseases (IHD) are important causes of death in Brazil.
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.
Pharmacy is the science and technique of preparing as well as dispensing drugs and medicines. It is a health profession that links health sciences with chemical sciences and aims to ensure the safe and effective use of pharmaceutical drugs. The scope of...
Clinical Approvals Clinical Trials Drug Approvals Drug Delivery Drug Discovery Generics Drugs Prescription Drugs In the fields of medicine, biotechnology and pharmacology, drug discovery is the process by which drugs are dis...