Who can benefit?

The WATCHMAN® left atrial appendage system is currently under a U.S. Clinical Study.  Patients who have non-valvular atrial fibrillation who require treatment for potential blood clot formation and can take anti-coagulation medication such as Coumadin® or warfarin may be eligible to participate.  Read on for further information.

Atrial Fibrillation

Atrial fibrillation can cause blood to stagnate and form clots in an area of your heart called the left atrial appendage.  Everyone has a left atrial appendage, it is a small pouch on the left side of your heart about the size of your thumb.  It has been well documented in the medical literature that more than 90% of clot found in patients with atrial fibrillation is found in the left atrial appendage.

Blood Thinning Medications

Treatments are currently available to protect you from stroke or related complications from blood clots. Your doctor may prescribe medication that thins your blood. One of the more common blood thinning medications (Coumadin® or warfarin) is effective in reducing the risk of stroke, but may cause undesirable side effects such as bleeding. These drugs can be affected by other factors such as diet and other medications and requires you to have your blood drawn frequently to monitor your dosage.

Alternative Treatment Options

Recently, alternatives to blood thinning medications have been developed.  Because
you have atrial fibrillation, it is believed that if the pouch in your heart called the left atrial appendage is isolated, then blood clots would not be able to exit that area which could possibly cause you harm.  The WATCHMAN® left atrial appendage system has been designed to be permanently implanted in the left atrial appendage of your heart.

The WATCHMAN® system has not yet been approved by the Food and Drug Administration (FDA), but is allowed by the FDA to be studied.  

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Do you have atrial fibrillation that requires you to be on blood thinning medications?

If so, you may be eligible for a clinical trial to evaluate the WATCHMAN® device that may replace your need for long term blood thinning medications.  Ask your doctor if you may be a candidate for this trial.

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For Investigational Use Only.