University of Nebraska Medical Center is leading a novel clinical trial assessing whether a device approved by the FDA can reduce the chance of a stroke in people with atrial fibrillation; could be safely implemented in people without using blood thinners.
The Research Site
University of Nebraska Medical Center (UNMC)
Andrew Goldsweig, MD assistant professor of interventional cardiology
The Study (ASAP TOO trial)
The Study lead site is enrolling patients in the ASAP TOO trial to test the WATCHMAN™LEFT Atrial Appendage Closure Device for a common hear problem—atrial fibrillation—a leading cause of stroke. The condition affects approximately 20% of men and 8% of women at some point in their lives.
UNMC is the only institution in the region participating in the research. Globally, 880 patients will be enrolled at 130 sites in the 20 countries. The study will last for 5 years.
The ASAP TOO trial is designed to test whether WATCHMAN can be used without blood thinners. Investigator Goldberg noted “Stroke rates in patients with atrial fibrillation are extremely high” and further “Blood thinners such as warfarin prevent clots. But if you can’t take blood thinners because of various health reasons and have atrial fibrillation, your default therapy has been nothing.”
This occurs when the heart’s system gets “short circuited,” reducing the expulsion of blood from a pocket in the heart called the left atrial appendage. Stagnant blood in the left atrial appendage can result in clots.
The Product (WATCHMAN™)
The device, the WATCHMAN, is manufactured by Boston Scientific. Normally requires patients to take 45 days of blood thinners following implementation during which time the lining of the heart grows over the device to prevent clots. People who cannot tolerate blood thinners for 45 days have previously been unable to receive the device, which has been approved since 2015.
The device is a filter that is implanted at the opening of the left atrial appendage via a catheter from a leg in a minimally-invasive procedure under ultrasound and X-ray guidance. A one night hospital stay is typical with no other significant recovery time.
The Commercial Sponsor