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Conventional hemodynamic monitoring / Microaxial flow pump (left ventricular assist device) / Heart Failure, Acute · Interventional Study
ClinicalTrials.gov · August 13, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a registry record for a planned 2×2 factorial randomized trial comparing microaxial left ventricular assist device support and protocol-based pulmonary artery catheter monitoring versus standard care in acute myocardial infarction complicated by cardiogenic shock, with all-cause mortality at 180 days as the primary endpoint. No results are posted; the study has not yet begun recruitment and therefore cannot inform clinical practice at this time.
Interventional, Randomized, Factorial, Open label, Treatment purpose. Cardiogenic Shock, Acute Myocardial Infarction (AMI), Heart Failure, Acute; age from 18 Years; to 80 Years. Intervention: Microaxial flow pump + pulmonary artery catheter; Microaxial flow pump + conventional monitoring. Compared with: Medical therapy + pulmonary artery catheter — Active Comparator; Medical therapy + conventional monitoring — Active Comparator. n = 780. 1 site: Germany.
This is a registry record for a planned 2×2 factorial randomized trial comparing microaxial left ventricular assist device support and protocol-based pulmonary artery catheter monitoring versus standard care in acute myocardial infarction complicated by cardiogenic shock, with all-cause mortality at 180 days as the primary endpoint. No results are posted; the study has not yet begun recruitment and therefore cannot inform clinical practice at this time.
Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.
The source did not state who this applies to in practice.
This is a clinical trial registry record describing a planned interventional study with no results posted; the trial is not yet recruiting and cannot support any clinical evidence claim.
As stated by the source record.
Quoted from the source exactly as published.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT07762560). This is a study registration, not published results. Lead sponsor: Leipzig Heart Science gGmbH. Recruitment status: NOT_YET_RECRUITING. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 780 participants (ESTIMATED). Conditions: Cardiogenic Shock, Acute Myocardial Infarction (AMI), Heart Failure, Acute. Interventions: DEVICE: Microaxial flow pump (left ventricular assist device); DEVICE: Pulmonary artery catheter; PROCEDURE: Conventional hemodynamic monitoring; PROCEDURE: Hemodynamic stabilization. Primary outcome measures: all-cause death , 180 days after randomization. Brief summary: The goal of this clinical trial is to learn which treatment strategies improve survival in adult patients with acute myocardial infarction complicated by cardiogenic shock (AMI-CS). The main questions it aims to answer are: * Does the immediate use of a left-sided microaxial flow pump (Impella) after percutaneous coronary intervention (PCI) improve survival compared to initial medical therapy alone? * Does protocol-based hemodynamic monitoring and optimization using a pulmonary artery catheter (PAC) improve survival compared to conventional intensive care monitoring? Researchers will compare four treatment combinations to see if mechanical circulatory support and/or advanced hemodynamic monitoring reduce mortality in AMI-CS patients: * Microaxial flow pump + pulmonary artery catheter * Microaxial flow pump + conventional monitoring * Medical therapy alone + pulmonary artery catheter * Medical therapy alone + conventional monitoring Participants will: * Undergo immediate coronary angiography and PCI upon hospital admission Be randomly assigned to one of four treatment groups * Receive either immediate implantation of a microaxial flow pump or initial medical therapy with vasoactive agents following PCI * Be monitored either via pulmonary artery catheter with protocol-based hemodynamic optimization or via conventional intensive care monitoring * Be followed up at 30 days, 6 months and 12 monthsafter Randomization, with planned annual follow-up assessments for up to 10 years
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