NAVISTAR® THERMOCOOL® Catheter for the Treatment of Atrial Fibrillation

2014-08-27 03:53:05 | BioPortfolio


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.

Study Design

Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Heart Diseases




Arizona Arrhythmia Consultants
United States


Active, not recruiting


Biosense Webster, Inc.

Results (where available)

View Results


Published on BioPortfolio: 2014-08-27T03:53:05-0400

Clinical Trials [1693 Associated Clinical Trials listed on BioPortfolio]

NAVISTAR® THERMOCOOL® Catheter for the Treatment of Atrial Fibrillation- TX

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...

NAVISTAR® THERMOCOOL® SF Catheter: Observational Study

This is a prospective, interventional, observational, unblinded, single-arm, multicenter registry of younger and older subjects with drug refractory, recurrent, symptomatic paroxysmal atri...

Catheter Evaluation for Endocardial Ablation in Patients With Ventricular Tachycardia

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...

Review of the Safety and Effectiveness of the THERMOCOOL SMARTTOUCH® SF Catheter Evaluated for Treating Symptomatic PersistenT AF (PRECEPT)

This is a prospective, multicenter, non-randomized clinical evaluation utilizing the THERMOCOOL SMARTTOUCH® SF catheter compared to a predetermined performance goal.

nMARQ™ Pulmonary Vein Isolation System for the Treatment of Paroxysmal Atrial Fibrillation

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...

PubMed Articles [11830 Associated PubMed Articles listed on BioPortfolio]

Safety and efficiency of porous-tip contact-force catheter for drug-refractory symptomatic paroxysmal atrial fibrillation ablation: results from the SMART SF trial.

THERMOCOOL SMARTTOUCH® SF Catheter is a new contact-force (CF)-sensing catheter with 56-hole porous tip designed for improved cooling and reduced fluid delivery compared with a standard 6-hole open-i...

Frequency, Indications And Complications Of Pulmonary Artery Catheter Insertion In Adult Open-Heart Surgery Patients Of A Tertiary Care Hospital.

Patients presenting for cardiac surgery have unstable cardiovascular disease and haemodynamics with multiple coexisting diseases. Optimal monitoring in the perioperative period is very important for b...

Patient-prosthesis mismatch in new generation trans-catheter heart valves: a propensity score analysis.

When compared with the former Sapien XT (XT-THV), the Sapien 3 trans-catheter heart valve (S3-THV) embeds an outer annular sealing cuff to prevent para-valvular regurgitation (PVR). The consequences o...

Evaluation of Ablation Catheter Technology: Comparison between Thigh Preparation Model and an In-Vivo Beating Heart.

An in-vivo animal thigh model is the standard technique for evaluation of ablation catheter technologies, including efficacy and safety of ablation. However, the biophysics of ablation in a thigh mode...

Atrial Fibrillation in Heart Failure US Ambulatory Cardiology Practices and the Potential for Uptake of Catheter Ablation: An National Cardiovascular Data Registry (NCDR(®)) Research to Practice (R2P) Project.

Atrial fibrillation (AF) and heart failure with reduced ejection fraction frequently coexist. The AATAC (Ablation versus Amiodarone for Treatment of persistent Atrial fibrillation in patients with Con...

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.

A hindrance to the passage of fluids through a CATHETER.

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.

More From BioPortfolio on "NAVISTAR® THERMOCOOL® Catheter for the Treatment of Atrial Fibrillation"

Quick Search

Relevant Topics

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...

Drug Discovery
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...

Searches Linking to this Trial