Stroke Prevention
Novel Device May Help Prevent Stroke in Atrial Fibrillation Patients
Research data suggests that more than 95 percent of blood clots causing stroke in atrial fibrillation patients occur in the heart's left atrial appendage, says D. Scott Lim, M.D., a cardiologist at the University of Virginia Health System.
UVA is a part of the PROTECT-AF trial, which is examining the effectiveness of the WATCHMAN left atrial appendage occluder in preventing embolic stroke compared with the standard treatment of anticoagulation with Coumadin. The novel device intends to prevent stroke by placing a small filter in this part of the heart.
The multicenter trial at 30 medical centers around the U.S. is a Phase II FDA-mandated investigation focusing on the WATCHMAN device's efficacy in a high-risk subset of patients with atrial fibrillation. The first phase of the trial has already helped to establish the device's safety profile, particularly in light of the known bleeding risks with Coumadin anticoagulation. The PROTECT-AF trial is randomized in a 2:1 fashion with a non-inferiority design compared with Coumadin.
The WATCHMAN device is self-expanding, made of nitinol, and is inserted through a venous catheter into the patient's left atrial appendage to trap off any blood clots. To be eligible for the trial, patients must be adults with atrial fibrillation who are able to take Coumadin, Lim says.
Access to clinical trials such as PROTECT-AF - and access to leading-edge treatment options - is among the benefits patients receive at UVA's Atrial Fibrillation Center. The center's multidisciplinary team - including electrophysiologists, NPs, PAs and research and educational coordinators - works closely with referring physicians through consultations or referrals to develop treatment plans for atrial fibrillation patients. Patients at UVA benefit from an individualized treatment plan tailored to their condition and have access to comprehensive treatment options, including ablation procedures, medical therapies and device implantation.
To refer a patient for the PROTECT-AF clinical trial or for atrial fibrillation treatment, call UVA Physician Direct at 800-552-3723.