Trial rationale

CHAMPION-AF trial results

The CHAMPION-AF clinical trial met its’ primary and secondary endpoints at 36 months. 

The trial results showed  WATCHMAN FLX™ provided statistically superior protection from bleeding and similar efficacy compared to NOACs in patients with NVAF.

Download the clinical summary

CHAMPION-AF met primary safety and efficacy endpoints 

Primary Safety Endpoint met

WATCHMAN FLX™ demonstrated statistical superiority to NOACs for the occurrence of ISTH non-procedural major bleeding and modified* clinically relevant non-major bleeding (10.9% vs. 19.0%; psuperiority <0.0001).

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Primary Efficacy Endpoint met

WATCHMAN FLX™ demonstrated statistical non-inferiority to NOACs for the occurrence of stroke (ischemic and/or hemorrhagic), cardiovascular (CV) death (hemorrhagic and/or unexplained death), and systemic embolism (5.7% vs. 4.8%; pnon-inferiority <0.0001).

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CHAMPION-AF met secondary net clinical benefit endpoint

Secondary Net Clinical Benefit Endpoint met

WATCHMAN FLX™ demonstrated statistical non-inferiority/superiority to NOACs for the occurrence of cardiovascular (CV), death, stroke, systemic embolism, and non-procedural major and modified clinically-relevant non-major bleeding. (15.1% vs. 21.8%; pnon-inferiority/superiority <0.0001). 

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Read the full publication

Upcoming CHAMPION-AF events 

In the next months, the implications of the CHAMPION-AF trial results will be addressed at the following events. Contact the organising entities to gain access to the events. 

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*Modified ISTH clinically relevant non-major bleeding: does not fit criteria for the ISTH definition of major bleeding but requires hospitalization or increased level of care.

References

S.K. Doshi, M.D. et.al. Left Atrial Appendage Closure or Anticoagulation for Atrial Fibrillation. The New England Journal of Medicine.  (2026). https://www.nejm.org/doi/full/10.1056/NEJMoa2517213

 

 

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