Clinical trial leads to FDA approval of stroke-prevention device
As a leader in cardiac care, The University of Vermont Medical Center offers advanced expertise in the treatment of heart rhythm disorders. Our experience is backed by a robust clinical research program that gives patients access to promising technologies and treatments not available elsewhere.
Now, thanks to our participation in a national clinical trial, the Watchman Left Atrial Appendage Closure Device, which reduces the risk of clot formation and stroke in patients with atrial fibrillation, has received FDA approval.
We were among a select group of academic medical centers around the country – and the only New England hospital north of Boston – to participate in the trial testing the implantable Watchman Device, which eliminates the need for blood thinners in patients with atrial fibrillation who are at high risk for developing strokes.
In atrial fibrillation, blood tends to pool in the left atrial appendage (LAA), and this stagnant blood can form clots. As a result, atrial fibrillation is associated with a two-fold greater risk of stroke. The Watchman Device works by permanently plugging the LAA, preventing the formation of clots.
We played a prominent role in getting FDA approval for the Watchman device. We had robust enrollment in the study, and some of the participants have gone on to advocate for this technology on a national level. As a result, we now have a multidisciplinary program in place that makes this device available to our patients who can benefit from it. ”Dan Lustgarten, MD, professor of Medicine, Robert Larner, M.D. College of Medicine at The University of Vermont