Lakeland, FL – The Watson Clinic Center for Research is proud to take part in an exciting new clinical study that will evaluate whether a one-time WATCHMAN FLX™ procedure is equally effective as blood thinning medication as a first-line treatment for a wider population of patients with non-valvular atrial fibrillation. The study is being led by Watson Clinic cardiologist Neal G. Kavesh, MD, FACC, FHRS alongside study co-investigators Douglas Ebersole, MD, FACC and Jami Sharik, APRN.
In October 2020, Boston Scientific began the enrollment of CHAMPION-AF, a randomized head-to-head trial designed to evaluate the safety and efficacy of the next-generation WATCHMAN FLX™ Left Atrial Appendage Closure (LAAC) Device within a broad population of patients with non-valvular atrial fibrillation (AF), including those who are at low-to-moderate risk of bleeding from the use of blood thinners. The device will be compared to non-vitamin K antagonist oral anticoagulants (NOACs), considered the leading contemporary drugs for stroke risk reduction in this population. The trial will study 3,000 patients suitable for oral anticoagulation across a broad spectrum of bleeding risk. Watson Clinic is one of approximately 150 global sites where patients will be randomized to receive either the WATCHMAN FLX device or a NOAC and be evaluated for rates of stroke, bleeding and other major adverse events over five years.
“We are pleased to participate in this important study,” said Dr. Kavesh. “A positive outcome from the CHAMPION-AF trial may put this device on equal footing with best-in-class drug therapy for stroke risk reduction, and offer an alternative for more patients who would otherwise face life-long use of blood thinners and the associated risk of serious bleeding.”
Patients with AF are five times more likely to suffer a stroke than someone with a normal heart rhythm. In people NVAF, more than 90% of stroke-causing blood clots that come from the heart are formed in the left atrial appendage. The WATCHMAN FLX device is designed to reduce the risk of stroke in people with non-valvular AF by closing off this area of the heart, while helping patients discontinue long-term use of blood thinners. The next-generation WATCHMAN FLX device was designed to advance procedural performance and safety and treat a wider range of patient anatomies. It features a new rounded frame to allow physicians to safely enter and maneuver within the left atrial appendage and is the first LAAC device that can be fully recaptured, repositioned and redeployed for precise placement. It is also available in broader size options than the previous generation device. The WATCHMAN FLX device, which received FDA approval in July 2020 and CE Mark in March 2019, builds upon the original WATCHMAN™ Left Atrial Appendage Closure Device that has been used to treat more than 100,000 patients worldwide.
Founded in 1985, the Watson Clinic Center for Research provides an administrative structure upon which Watson Clinic specialists can perform medical research. Through numerous patient-oriented prospective and retrospective research trials, the Center for Research seeks to improve treatments and outcomes. The Watson Clinic physicians are working closely with the Center for Research to provide meaningful contributions to the pool of evidence-based knowledge from which all medical professionals draw. For more information on the Watson Clinic Center for Research, visit WatsonClinic.com/clinical-trials or call 863-688-6826.
About Watson Clinic LLP: As one of the largest multispecialty medical clinics in the southeast, Watson Clinic provides comprehensive healthcare services to residents of Lakeland and surrounding communities. First established in 1941, Watson Clinic has grown to include over 220 board-certified physicians representing more than 40 medical and surgical specialties. The Clinic is proud to deliver quality healthcare to every generation from our Main Clinic location at 1600 Lakeland Hills Boulevard in Lakeland, as well as at multiple convenient locations throughout Polk, Pasco and Hillsborough counties. More information is available at: www.WatsonClinic.com.