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Clinical Trials in Germany / NCT07655479
Recruiting Observational

Rapid Microaxial Flow Pump Support and Escalation in Patients With Myocardial Infarction Associated Cardiogenic Shock and Persistent Need of Hemodynamic Support

NCT07655479 · tracked via the Priya Life Science Germany tracker
Phase
Observational
Started
2026-04-23
Last updated
2026-08-27

Condition(s) studied

Cardiogenic Shock Post Myocardial Infarction

Investigational drug(s) / intervention(s)

Escalation to more capable microaxial flow-pump (Impella 5.5)

Escalation to more capable microaxial flow-pump (Impella 5.5): Rapid escalation from Impella CP to Impella 5.5 within 24 hours post revascularization

Study summary

The aim of this trial is to evaluate whether a structured and time-optimized escalation strategy from a transfemoral microaxial flow-pump (Impella CP™) to the Impella 5.5™ microaxial flow-pump is associated with improved clinical outcomes and fewer adverse events in patients with cardiogenic shock due to acute myocardial infarction

Eligibility

Sex
ALL
Min age
18 Years
Max age
77 Years
Healthy volunteers
No
Inclusion Criteria: 1. Age ≥18 years and ≤77 years 2. Patients with ACS-CS (STEMI and NSTEMI with a culprit lesion that received revascularisation) and Impella CP™ support during initial revascularisation 3. The following additional parameters must be met at the time of initial revascularisation procedure: 1. Hypotension or need for inotropes AND 2. Lactate \> 2.5 mM AND 3. Left ventricular ejection fraction (EF) \< 45% 4. Need for escalation to Impella 5.5 at the discretion of the treating physician and the following criteria are fulfilled: 1. Decision for Impella 5.5 escalation within 6 ± 1 hours after completion of initial revascularisation procedure 2. Escalation to Impella 5.5procedure is initiated within 24 hours after completion of the initial revascularisation procedure 5. Need for inotropes and/or vasopressors with VIS \> 5 but ≤ 50 at Impella CP™ support at level P7 or above at 6+1 hours after completion of initial revascularisation procedure 6. Prospective Informed Consent obtained from the patient or deferred consent according to "Cologne Model" applied. Exclusion Criteria: 1. Implanted VA-ECMOwithin 6 ± 1 hours after initial revascularisation Note: If VA-ECMO support is needed between 6 ± 1 hours after initial revascularisation and escalation to Impella 5.5, patients will be included forlimited data collection per Table 2 only. In this case the same Informed Consent Process as for regular trial participants applies. 2. Elevated risk of hypoxic brain injury indicated by MIRACLE2 score \>3 (Aldous et al., 2023) 3. Platelet count \<75,000 cells/mm3, bleeding diathesis or active bleeding, coagulopathy or unwillingness to receive blood transfusions 4. Active bleeding (e.g. access site bleeding or GI bleeding, etc.) with need for transfusion within 6 ± 1 hours after initial revascularisation 5. Any contraindication listed in the Impella 5.5 IFU if known to be present 6. Chronic haemodialysis and/or chronic kidney disease stage G5 according to KDIGO 7. Pregnancy or lactation, if known 8. Participation in the active treatment or follow-up phase of another clinical study of an investigational drug or device that has not reached its primary endpoint, if known

Primary outcome measure(s)

Trial sites (3)

FacilityCityRegionStatus
University Hospital Düsseldorf Düsseldorf North Rhine-Westphalia Recruiting
University Hospital Schleswig-Holstein, Campus Kiel Kiel Schleswig-Holstein Recruiting
University Hospital Cologne Cologne Germany Recruiting

More University Hospital of Cologne trials in Germany

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07655479 on ClinicalTrials.gov ↗ ← All trials in Germany