Trial Information

Summary: AN IMPORTANT CLINICAL TRIAL FOR ATRIAL FIBRILLATION

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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.

You may be eligible to participate in this study if you:

• Have failed to respond to drug treatment for your AFib, or find the side effects of your medication intolerable
• Are 18 years of age or older

To see if you are eligible, or for more information, call toll-free 866-788-3933

Click here to fill out our online questionnaire to see if you pre-qualify for participation. By answering these questions, you are not obligated to participate in this study. The purpose of these questions is only to determine if you might qualify. You are free at any time to make a decision about your participation in this process.

This site is run by CenterWatch, a publishing company that focuses on the clinical trials industry. The information provided in this service is designed to help patients find clinical trials that may be of interest to them, and to help patients contact the centers conducting the research. CenterWatch is neither promoting this research nor involved in conducting any of these trials.

Trial listings updated: June 1, 2008 at 6:32:35 AM