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Clinical Trial 1316


Study Summary:

NAVISTAR® THERMOCOOL® Catheter for the Radiofrequency Ablation of Symptomatic Paroxysmal Atrial Fibrillation

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Atrial fibrillation (AFib) is a rhythm disturbance of the heart and the most common arrhythmia in clinical practice. The heart rate of an AFib patient is between 300-600 beats per minute. An individual who spontaneously alternates between AFib and a normal heart rhythm is said to have paroxysmal atrial fibrillation (PAF). PAF is often difficult to diagnose; some patients may be asymptomatic while other patients may report symptoms such as palpitations, fainting, and chest pain. In addition to potentially life-altering symptomatic episodes, individuals with AFib have a mortality rate that is twice as high as those with normal sinus rhythm and have a risk of ischemic stroke between 2 and 7 times that of those without AFib.1

Anti-arrhythmic drug therapy fails to control atrial fibrillation (AFib) in many patients, who may also experience intolerable side effects from their medications. In the past decade, a number of catheter ablation approaches have been investigated to treat AFib.

Catheter ablation is a procedure used to destroy (ablate) areas of the heart muscle that are causing the arrhythmias. In a radiofrequency (RF) catheter ablation procedure, electrophysiologists pinpoint the area and then use radio wave energy to cauterize the aberrant heart tissue causing the heart rhythm abnormality. Ablation therapy is a treatment option for patients who have not benefited from anti-arrhythmic drug (AAD) therapy or do not tolerate the appropriate AAD therapy. Antiarrhythmic drug therapy, the first choice of the AHA therapy guidelines, fails to control AFib for one year in more than 50% of individuals treated.1,2 Catheter RF Ablation is a relatively non-invasive procedure that can, if successful, restore a normal heart rhythm, and possibly eliminate the need for open-heart surgery or long-term drug therapies. This clinical trial is evaluating the safety and effectiveness of catheter ablation as a treatment alternative to chronic drug therapy for PAF patients.2

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.

Trial parameters:
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.

Patients with symptomatic PAF who are 18 years and older will be considered for the study.

Qualified Participants Must:

• Have Paroxysmal AFib
• Have had 3 episodes in prior 6 months, one documented
• Have failure of at least one antiarrhythmic drug (class I or III, or AV nodal blocking agents such as beta blockers, calcium channel blockers) or intolerable side effects

Please help advance the treatment of AFib. Refer your eligible patients today.

Qualified Participants May Receive:

Compensation is offered for time and travel. unique visitor counter

Clinical trials are medical research studies designed to test the safety and/or effectiveness of new investigational drugs, devices, or treatments in humans. These studies are conducted worldwide for a range of conditions and illnesses. Learn more about clinical research and participating in a study at About Clinical Trials.