Boston Scientific Initiates Trial to Evaluate WATCHMAN FLX as Treatment for Risk of Stroke

Boston Scientific has initiated the CHAMPION-AF clinical trial to evaluate the safety and efficacy of the WATCHMAN FLX™ Left Atrial Appendage Closure (LAAC) Device within a broad population of patients with non-valvular atrial fibrillation (NVAF), including those who are at low-to-moderate risk of bleeding from the use of anticoagulation. The device will be compared to treatment with non-vitamin K antagonist oral anticoagulants (NOACs), considered the leading contemporary drugs for stroke risk reduction in this population.

Approximately 33 million people worldwide have AF, a common heart rhythm disorder, which makes them five times more likely to have a stroke than someone with a normal heart rhythm. In patients with NVAF, more than 90% of heart-related blood clots form in the left atrial appendage.3 The WATCHMAN FLX device is designed to close off this area of the heart permanently, providing a one-time solution for those who need an alternative to anticoagulation to reduce their risk of stroke.

The randomized CHAMPION-AF trial will enroll 3,000 patients with NVAF who are suitable for oral anticoagulation therapy across a broad spectrum of stroke and bleeding risk. Patients at approximately 150 global sites will be randomized to receive the newest-generation WATCHMAN FLX device or a NOAC and will be followed for five years. The trial will evaluate the rates of cardiovascular death, stroke, systemic embolism and post-procedural major or clinically relevant non-major bleeding.

"The CHAMPION-AF trial will compare the WATCHMAN FLX device in a head-to-head fashion against best-in-class pharmacological therapy for stroke prevention and evaluate the technology as a first-line therapy for those who can tolerate anticoagulation," said Dr. Ian Meredith, global chief medical officer, Boston Scientific. "A positive outcome for this study has the potential to change clinical practice and expand device access to more patients who would benefit from a one-time procedural alternative to the long-term use of blood thinners and their potential side effects, including those patients at low-to-moderate bleeding risk."

The CHAMPION-AF trial will add to the body of clinical evidence for the WATCHMAN FLX device, along with PINNACLE FLX and the currently-enrolling OPTION trial, a randomized controlled study comparing the device to oral anticoagulants – including but not limited to NOACs – in patients with non-valvular AF who also undergo a cardiac ablation procedure.