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

NCT07655479 | Not Yet Recruiting FDA Device

• 2 other identifiers: 25-1387HORIZON-JU-IHI-2025-09
• Study Type: observational
• Target: 115
• Locations: 0 countries
• Sites: N/A

Brief 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

Conditions

Cardiogenic Shock Post Myocardial Infarction

Keywords

Impella; Microaxial Flow-pump; cardiogenic shock; myocardial infarction

Outcome Measures

Primary Outcomes (1)

• Vasoactive Hemodynamic Score (VHS) < 5

  Vasoactive Hemodynamic Score = Hemodynamic Score (HS) x Vasoactive-Inotropic Score (VIS) Higher VHS indicates more severe hemodynamic compromise relative to degree of pharmacological circulatory support. Range: Minimum 1, Maximum 110 Hemodynamic Score: HS = Points are allocated for measured heart rate, mean arterial blood pressure and arterial lactate (minimum 1, maximum 11) Vasoactive-Inotropic Score: Points are allocated for every 10 increment according to the following formula: Dopamine dose (μg/kg/min) + Dobutamine dose (μg/kg/min) + 100 x Epinephrine dose (μg/kg/min) + 10 x Milrinone (μg/kg/min) + 100 x Norepinephrine dose (μg/kg/min) + 50 x Levosimendan dose (μg/kg/min)

  48 hours post revascularization

Secondary Outcomes (17)

• All-cause mortality

  In-hospital or 30 days post revascularization (whatever comes first)

• All-cause mortality

  180 days post revascularization

• Cardiac output

  At time of enrolment, 48 hours as well as 72 hours post revascularization.

• Vasoactive-Inotropic Score (VIS)

  At time of enrolment, 48 hours as well as 72 hours post revascularization.

• Lactate

  At time of enrolment, 48 hours as well as 72 hours post revascularisation

Study Arms (1)

Device Group

Rapid escalation to Impella 5.5

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

Interventions

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

Rapid escalation from Impella CP to Impella 5.5 within 24 hours post revascularization

Device Group

Eligibility Criteria

• Age: 18 Years - 77 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with ACS-CS (STEMI or NSTEMI) who undergo Impella CP™-supported revascularisation of the culprit lesion and are considered for escalation to Impella 5.5 at the discretion of the treating investigator will be assessed for eligibility to participate in this observational study.

You may qualify if:

• Age ≥18 years and ≤77 years
• Patients with ACS-CS (STEMI and NSTEMI with a culprit lesion that received revascularisation) and Impella CP™ support during initial revascularisation
• The following additional parameters must be met at the time of initial revascularisation procedure:
• Hypotension or need for inotropes AND
• Lactate \> 2.5 mM AND
• Left ventricular ejection fraction (EF) \< 45%
• Need for escalation to Impella 5.5 at the discretion of the treating physician and the following criteria are fulfilled:
• Decision for Impella 5.5 escalation within 6 ± 1 hours after completion of initial revascularisation procedure
• Escalation to Impella 5.5procedure is initiated within 24 hours after completion of the initial revascularisation procedure
• 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
• Prospective Informed Consent obtained from the patient or deferred consent according to "Cologne Model" applied.

You may not qualify if:

• 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.
• Elevated risk of hypoxic brain injury indicated by MIRACLE2 score \>3 (Aldous et al., 2023)
• Platelet count \<75,000 cells/mm3, bleeding diathesis or active bleeding, coagulopathy or unwillingness to receive blood transfusions
• Active bleeding (e.g. access site bleeding or GI bleeding, etc.) with need for transfusion within 6 ± 1 hours after initial revascularisation
• Any contraindication listed in the Impella 5.5 IFU if known to be present
• Chronic haemodialysis and/or chronic kidney disease stage G5 according to KDIGO
• Pregnancy or lactation, if known
• 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

Sponsors & Collaborators

• University Hospital of Cologne: lead
• Johnson & Johnson: collaborator

MeSH Terms

Conditions

Shock, Cardiogenic; Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Shock

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. med.

Study Record Dates

• First Submitted: April 21, 2026
• First Posted: June 17, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): October 1, 2028
• Last Updated: June 17, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share