CHAMPION-AF Clinical Trial
Why CHAMPION-AF?
The CHAMPION-AF trial evaluates LAAC versus NOAC in a broad NVAF patient population to establish WATCHMAN FLXTM as a first-line stroke risk-reduction therapy.
LAAC with WATCHMANTM or WATCHMAN FLX is currently used for patients who can tolerate short-term oral anticoagulation (OAC) therapy, but are considered poor candidates for long-term OAC.
However, there is a large population of low to moderate bleed risk patients* who can tolerate long term OAC, but would benefit from a one time, FDA-approved device alternative that offers a lifetime of safe and effective stroke risk reduction.
Trial Design and Primary Endpoints
![CHAMPION-AF Trial Design Endpoints](https://www.bostonscientific.com/en-US/products/laac-system/champion-af-clinical-trial/champion-af-clinical-trial-for-physicians/champion-af-clinical-trial/_jcr_content/maincontent-par/image_copy_303609705.img.c-af_trial_design_endpoints.jpg)
Primary Endpoints:
- WATCHMAN FLX is non-inferior for the occurrence of stroke (including ischemic and/or hemorrhagic), cardiovascular (CV) death (including hemorrhagic and/or unexplained death), and systemic embolism at 36 months.
- WATCHMAN FLX is superior for non-procedural bleeding (ISTH major bleeding and clinically relevant non-major bleeding) at 36 months.
- WATCHMAN FLX is non-inferior for the occurrence of ischemic stroke and systemic embolism at 60 months.
Trial Timeline
![WATCHMAN FLX LAAC Device Group Chart](https://www.bostonscientific.com/en-US/products/laac-system/champion-af-clinical-trial/champion-af-clinical-trial-for-physicians/champion-af-clinical-trial/_jcr_content/maincontent-par/image_625080168_copy.img.c-af_device_arm_chart.png)
![NOAC Group Chart](https://www.bostonscientific.com/en-US/products/laac-system/champion-af-clinical-trial/champion-af-clinical-trial-for-physicians/champion-af-clinical-trial/_jcr_content/maincontent-par/image_248974783_copy.img.c-af_NOAC_arm_chart.png)
Patient Brochure
View the orderable patient-facing brochure created to give your trial candidates an overview of the CHAMPION-AF clinical trial.
Contact your WATCHMAN Representative to order patient brochures for your center.
Patient Selection
![group of people smiling and looking happy](https://www.bostonscientific.com/en-US/products/laac-system/champion-af-clinical-trial/champion-af-clinical-trial-for-physicians/champion-af-clinical-trial/_jcr_content/maincontent-par/image_1572168977_cop.img.c-af_patient_selection.jpg)
![Find a Trial Site Find a Trial Site](/content/dam/bostonscientific/Rhythm%20Management/portfolio-group/WATCHMAN/champion-af/physician/c-af_find_a_trial_background.jpg)
Find a Trial Site
Boston Scientific has selected US sites to be CHAMPION-AF investigational centers. If you have a candidate in mind, view the active trial list provided by clinicaltrials.gov, and reach out to a study physician near you to discuss next steps for referral.