A new clinical trial underway for patients with atrial fibrillation will test an implantable device in place of a common blood-thinning medication, according to researchers at Emory University Hospital Midtown.
Atrial fibrillation (commonly called A-fib) is a heart condition in which the upper chambers of the heart beat too fast, causing an irregular heartbeat and ineffective pumping action. This condition can cause blood to pool and form clots in the left atrial appendage (LAA). If a clot forms in this area, it can increase the chances of having a stroke.
Many patients with A-fib are prescribed blood-thinning medications, such as warfarin (brand name Coumadin), to prevent blood from clotting. This medication is effective in reducing the risk of stroke, but may cause side effects such as bleeding. It also requires frequent blood draws to monitor dosage levels.
The trial, called PREVAIL (Prospective Randomized EVAluation of the Watchman LAA Closure Device In Patients with Atrial Fibrillation Versus Long Term Warfarin Therapy), involves implanting a small, umbrella-shaped mesh device called the Watchman closure device, into the heart chamber via catheter. This is a confirmatory study (and the third study testing the implant), which will also look at safety and efficacy of the device.
David De Lurgio, MD, associate professor of medicine in the Division of Cardiology, Emory University School of Medicine, is the principal investigator of the trial. He explains that by implanting this device into the left atrial appendage of the heart, it closes that area off. That, in turn, prevents blood clots from escaping and entering the blood stream, which could lead to a stroke.
Patients are randomly selected by computer to either receive the device or remain on Coumadin without the device (control group). Those selected to receive the device will remain on Coumadin for 45 days following implant. If the heart tissue has healed after those 45 days, participants will be taken off Coumadin and placed on aspirin therapy and possibly clopidogrel (Plavix), an anti-platelet medication.
Researchers will then follow study patients with and without the device for five years, monitoring those who are no longer taking Coumadin very closely. If the FDA approves the device at the end of this clinical trial, participants in the control group will then have the option to receive the device.
De Lurgio and his colleagues have had five years of experience with this technology, thus far. Emory Healthcare is the only health system in Georgia providing access to this device through participation in this clinical trial.
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