Clinical Trial 700

Orlando, FL 32083

Study Summary:

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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.

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Qualified Participants Must:

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

Qualified Participants May Receive:

Compensation is offered for time and travel.

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.