CHAMPION-AF Clinical Trial

CHAMPION-AF Clinical Trial

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 FLXTM or WATCHMANTM FLX ProTM 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, CE mark and 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

A hierarchy chart showing the study design of CHAMPION-AF.

Primary Endpoints:

  • WATCHMAN FLXTM 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 FLXTM is superior for non-procedural bleeding (ISTH major bleeding and clinically relevant non-major bleeding) at 36 months. 
  • WATCHMAN FLXTM 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.

A timeline showing how the watchman flx arm is followed up during CHAMPION-AF.
A timeline showing how the NOAC arm is followed up during CHAMPION-AF.

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

Is your patient eligible for LAAC? Download the patient brochure to explore treatment options beyond long-term anticoagulation.

View brochure
brochure

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CHAF Trial Results

Patient Selection

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

Patient Selection

CAUTION:

The law restricts these devices to sale by or on the order of a physician. Indications, contraindications, warnings, and instructions for use can be found in the product labelling supplied with each device or at www.IFU-BSCI.com. Products shown for INFORMATION purposes only and may not be approved or for sale in certain countries. This material not intended for use in France.