American heart journal · 2026
Design and rationale of the Impella®-protected cardiac surgery trial (IMPACT): A multicenter, single-arm pilot study in high-risk cardiac surgery patients.
СтатьяПротокол клинического исследованияНазвание и аннотация: Перевод в очереди
Обработка статьи · этапы, ошибки и управление
Загрузка состояния…
Ошибки и ограничения
История · было → стало
Состояние обновляется каждые 5 секунд, пока блок открыт. Процент показывается только там, где известен объём работы. Пауза останавливает продолжение этапа; текущий запрос к источнику может завершиться.
Goldstein Daniel J, Reichenspurner Hermann, Vorovich Esther, Teuteberg Jeffrey, Ramzy Danny, Lobdell Kevin W, Parks Randi J, May Alexandra, Aggarwal Sanjeev, Soltesz Edward G
Аннотация
BACKGROUND: Cardiac surgery patients with severe preoperative left ventricular (LV) dysfunction are at high risk for poor postoperative outcomes including prolonged ventilation, renal failure and post-cardiotomy cardiogenic shock (PCCS). Mortality and morbidity remain high for patients who develop PCCS, thus mandating the availability of more effective prophylactic and treatment options.
METHODS: The Impella®-Protected Cardiac Surgery Trial (IMPACT) is a prospective, multicenter, single-arm pilot study assessing Impella 5.5® use prior to weaning from cardiopulmonary bypass in high-risk cardiac surgery patients. Key inclusion criteria are a baseline LV ejection fraction ≤25% or ≤35% with significant mitral regurgitation and planned mitral valve replacement or repair (MVR), and undergoing planned, on-pump isolated coronary artery bypass grafting, MVR, aortic valve replacement, or a combination of these with or without tricuspid valve replacement. The primary effectiveness endpoint is the rate of PCCF at hospital discharge. The primary safety endpoint is the composite of all-cause mortality, stroke and new requirement for renal replacement therapy evaluated through 90 days post-operation. Additional secondary endpoints include hospital and ICU lengths of stay, vasoactive-inotropic score, duration of mechanical ventilation and cardiovascular mortality. A concurrent registry will aim to collect data on patients not approached for study enrollment or who do not meet all inclusion and exclusion criteria.
CONCLUSIONS: IMPACT results will provide data on trial and technique feasibility, patient selection criteria and aid in informing future trial designs.
TRIAL REGISTRATION: ClinicalTrials.gov, NCT05529654, https://clinicaltrials.gov/study/NCT05529654.
METHODS: The Impella®-Protected Cardiac Surgery Trial (IMPACT) is a prospective, multicenter, single-arm pilot study assessing Impella 5.5® use prior to weaning from cardiopulmonary bypass in high-risk cardiac surgery patients. Key inclusion criteria are a baseline LV ejection fraction ≤25% or ≤35% with significant mitral regurgitation and planned mitral valve replacement or repair (MVR), and undergoing planned, on-pump isolated coronary artery bypass grafting, MVR, aortic valve replacement, or a combination of these with or without tricuspid valve replacement. The primary effectiveness endpoint is the rate of PCCF at hospital discharge. The primary safety endpoint is the composite of all-cause mortality, stroke and new requirement for renal replacement therapy evaluated through 90 days post-operation. Additional secondary endpoints include hospital and ICU lengths of stay, vasoactive-inotropic score, duration of mechanical ventilation and cardiovascular mortality. A concurrent registry will aim to collect data on patients not approached for study enrollment or who do not meet all inclusion and exclusion criteria.
CONCLUSIONS: IMPACT results will provide data on trial and technique feasibility, patient selection criteria and aid in informing future trial designs.
TRIAL REGISTRATION: ClinicalTrials.gov, NCT05529654, https://clinicaltrials.gov/study/NCT05529654.