Erlanger Health System announces the Erlanger Heart and Lung Institute is participating in a clinical trial studying if blood thinners are more effective at preventing stroke in atrial fibrillation (AF) than the WATCHMAN device for left atrial appendage closure (LAAC).
According to the Centers for Disease Control, Patients with AF are five times more likely to suffer a stroke than someone with a normal heart rhythm. In people with non-valvular atrial fibrillation (NVAF), more than 90 percent 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 NVAF by closing off this area of the heart, while helping patients discontinue long-term use of blood thinners.
“We are pleased to participate in this important study that will evaluate whether a one-time WATCHMAN FLX procedure is equally as effective as blood thinning medication as a first time treatment for a wider population of patients with non-valvular AF,” said Dr. Megan Coylewright, director of the Erlanger Heart and Lung Institute’s Structural Heart Program and is serving on the global steering committee for this trial. “A positive outcome of this trial may put the device on equal footing with what is considered the 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.”
In October 2020, Boston Scientific began the enrollment of the CHAMPION-AF trials, a randomized head-to-head trial designed to evaluate the safety and efficacy of the WATCHMAN FLX LAAC Device within a broad population of patients with NVAF, 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.
According to Boston Scientific, the trial will study 3,000 patients suitable for oral anticoagulation across a broad spectrum of bleeding risk. Patients at approximately 150 global sites 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.
The 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.
For more information about Erlanger’s Structural Heart program visit erlanger.org/heart.