A new clinical trial underway for patients with atrial fibrillation — using an implantable device — may eliminate the need for 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 stagnate or 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. Blood-thinning drugs can also be affected by other factors, such as diet and other medications, and require 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 via 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), which 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, Emory University School of Medicine and principal investigator of this clinical trial. “We implant this device into the left atrial appendage of the heart, closing it off. This prevents blood clots from escaping and entering the blood stream, which could lead to a stroke.”
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 though participation in this clinical trial.
Patients are randomly selected by computer to either receive the Watchman device or remain on Coumadin without the device (control group).
In those selected to receive the device, physicians will implant the small device following a trans-esophageal echocardiogram, which images the LAA for any blood clots. After implantation, these patients will remain on Coumadin for 45 days, then the heart will be re-imaged. If the heart tissue has healed, 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 have come off of Coumadin very closely. If the FDA approves the device at the end of this clinical trial, those patients in the control group will then have the option to receive the device.
“If approved by the FDA at the end of our five year study, this device will give A-fib patients an alternative treatment option to using Coumadin,” says De Lurgio. Angel Leon, MD, professor of medicine, and Mikhael El Chami, MD, assistant professor of medicine, both in the Division of Cardiology at Emory, are also involved in this study.
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