CHAMPION-AF results to be presented at ACC.26
The results of the CHAMPION-AF trial have been accepted as a Late-Breaking Science session and will be presented at the American College of Cardiology’s 75th Annual Scientific Session & Expo in New Orleans (March 28-30).
Presentation Title: Outcomes in Patients with Atrial Fibrillation Randomized to Receive Left Atrial Appendage Closure or Oral Anticoagulation: Primary Results of the CHAMPION-AF Clinical Trial
Presenter: Saibal Kar, MD
Session/Date/Time:
Late-Breaking Clinical Trials 1
Saturday, March 28
9:30 AM – 10:30 AM CDT
What is the CHAMPION-AF Clinical Trial?
The CHAMPION-AF clinical trial seeks to establish WATCHMAN as a first-line stroke risk reduction option for most NVAF patients.
LAAC with the WATCHMAN Implant 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.
CHAMPION-AF is an IDE trial for WATCHMAN as a first line therapy.
Trial design and three-year primary and secondary endpoints
Primary Efficacy Endpoint
Stroke (including ischemic and/or hemorrhagic), cardiovascular (CV) death (including hemorrhagic and/or unexplained death), and systemic embolism (NON-INFERIORITY)
Primary Safety Endpoint
Non-procedural bleeding (ISTH major bleeding and modified** clinically relevant non-major bleeding) (SUPERIORITY)
Secondary Safety Endpoint
ISTH major bleeding (including procedural bleeding) (NON-INFERIORITY)
Secondary Net Clinical Benefit Endpoint
CV death, stroke, systemic embolism, non-procedural ISTH major and modified** clinically-relevant non-major bleeding (NON-INFERIORITY)
Learn about the first randomized, head-to-head study comparing WATCHMAN to OACs after cardiac ablation
* 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.
**Modified ISTH clinically relevant non-major bleeding was defined as any sign or symptom of hemorrhage (e.g., more bleeding than would be expected for a clinical circumstance, including bleeding found by imaging alone) that does not fit the criteria for the ISTH definition of major bleeding but does meet at least one of the following criteria.:
- Requiring medical intervention by a healthcare professional
- Leading to hospitalization or increased level of care (e.g., ER visit, diagnostic procedures, medication change)