Acute cardiac care & resuscitation

Design and rationale of the Impella®-protected cardiac surgery trial (IMPACT): A multicenter, single-arm pilot study in high-risk cardiac surgery patients

Am Heart JPublished prospective, multicenter, single-arm pilot study

Study context

Population
High-risk cardiac surgery patients with a baseline left ventricular (LV) ejection fraction ≤25% or ≤35% with significant mitral regurgitation and planned MVR, undergoing planned, on-pump isolated coronary artery bypass grafting, MVR, aortic valve replacement, or a combination of these with or without tricuspid valve replacement
Primary endpoint
Primary effectiveness endpoint: rate of PCCF; primary safety endpoint: composite of all-cause mortality, stroke and new requirement for renal replacement therapy (through 90 days post-operation)
Follow-up
Hospital discharge
Methodological detailsconcurrent registry of patients not approached for study enrollment or who do not meet all inclusion and exclusion criteria
  • Concurrent registry of patients not approached for study enrollment or who do not meet all inclusion and exclusion criteria

No results yet. This paper sets out the design of a trial; its results are to come.

Original publication

Design and rationale of the Impella®-protected cardiac surgery trial (IMPACT): A multicenter, single-arm pilot study in high-risk cardiac surgery patients. Am Heart J. Published 25 March 2026. doi:10.1016/j.ahj.2026.107434

Summarised from the published abstract; every number is checked against it

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