October 29, 2020
Boston Scientific Initiates CHAMPION-AF Trial of the Watchman FLX
October 29, 2020—Boston Scientific Corporation announced it 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 nonvalvular 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).
The first patient in the CHAMPION AF trial was enrolled by Devi Nair, MD, at St. Bernards Heart & Vascular Center in Jonesboro, Arkansas.
According to Boston Scientific, 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. Patients will be followed for 5 years.
The trial will evaluate the rates of cardiovascular death, stroke, systemic embolism, and postprocedural major or clinically relevant nonmajor bleeding.
The co-chairs for the trial are Marty Leon, MD, and Kenneth A. Ellenbogen, MD. The trials principal investigators are Saibal Kar, MD, and Shephal Doshi, MD.