CHAMPION-AF Clinical Trial

Why CHAMPION-AF?

The CHAMPION-AF trial evaluates LAAC versus NOAC in a broad NVAF patient population to establish WATCHMAN FLX^TM as a first-line stroke risk-reduction therapy.

LAAC with WATCHMAN^TM 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.

* Exclusion criteria includes patients who have had a prior major bleeding event in ISTH definition within the 30 days prior to randomization. Lack of resolution of related clinical sequelae or planned and pending interventions to resolve bleeding/bleeding source, are a further exclusion regardless of timing of the bleeding event.

Trial Design and Primary Endpoints

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

CHAMPION-AF is a randomized, controlled trial that will include 3,000 patients across 150 global sites. See below for an overview of both the device and control group treatment timelines.

NOTE: For Device and NOAC arms, annual clinical follow-up visits can be via phone or in-office, with the exception of the 3-year clinical follow-up visit, which must be in-office.

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

CHAMPION-AF intends to demonstrate WATCHMAN FLX as a first-line LAAC option versus NOAC to reduce stroke risk in NVAF patients, including lower-risk patients.

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.

Site Locator

WATCHMAN FLX Device Brief Summary

Top