Wednesday, March 16, 2011

Clinical Trial to Test Device

A new clinical trial referred to as PREVAIL, is underway for patients with Atrial Fibrillation. By using an implantable device, the need for a common blood-thinning device may be eliminated according to researchers at Emory University Hospital Midtown.

Atrial fibrillation commonly called A-fib is a heart condition where the upper chambers of the heart beat too fast, causing an irregular heartbeat and ineffective pumping action. This condition can cause blood to stagnate or pool and form clots in the left atrial appendage. If a clot forms in this area, chances increase for having a stroke.

Many patients with A-fib are prescribed blood thinning medications, to prevent blood clotting. While this medication is effective in reducing the risk of stroke, it may cause side effects such as bleeding.

The PREVAIL trial involves implanting via a catheter, a small umbrella-shaped mesh device called the “Watchman Closure Device” into the heart chamber to prevent stroke. This is a confirmatory study and the third study testing the implant but this study will also look at safety and efficacy of the device.

“We have had good success with this device in A-fib patients in two previous studies,” says David De Lurgio, MD, Associate Professor of Medicine in the Division of Cardiology, at the Emory University School of Medicine and Principal Investigator of this clinical trial.

De Lurgio and his colleagues Angel Leon, MD, Professor of Medicine, and Mikhael El Chami, MD, Assistant Professor of Medicine, have had five years of experience with this technology and so far, Emory Healthcare is the only health system in Georgia providing access to this device through participation in this clinical trial.

Patients are randomly selected by computer to either receive the “Watchman Closure Device” or to remain on Coumadin without the device. Those selected will receive the device and physicians will implant the small device following a trans-esophageal echocardiogram, which images the LAA for any blood clots.

After implantation, the patients remain on Coumadin for 45 days, at that time, the heart is again imaged. If the heart tissue has healed, participants will be taken off Coumadin and placed on aspirin therapy and possibly on Plavix an anti-platelet medication.

Researchers will follow the study patients with and without the device for five years, monitoring those that have stopped taking Coumadin very closely. If the FDA approves the device at the end of the clinical trial, those patients in control group will then have the option to receive the device.

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