Acute cardiac care & resuscitationTrial design
Design and rationale of the Impella®-protected cardiac surgery trial (IMPACT): A multicenter, single-arm pilot study in high-risk cardiac surgery patients
- prospective, multicenter, single-arm pilot study
- concurrent registry of patients not approached for study enrollment or who do not meet all inclusion and exclusion criteria
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
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