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Rapid heart pump upgrade may save lives in shock

NCT ID NCT07655479

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Aug 28, 2026 · Updated 2 times

Summary

This study tests whether quickly upgrading from a standard heart pump (Impella CP) to a more powerful one (Impella 5.5) within 24 hours after a heart attack improves outcomes for people in cardiogenic shock. The trial will enroll 115 adults aged 18-77 who have had a heart attack and need extra heart support. The goal is to see if this faster escalation reduces the need for strong medications and leads to fewer complications.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Impella heart pumps (Impella CP and Impella 5.5)
What this could lead to
If successful, this could lead to a faster, more effective way to support the heart during cardiogenic shock, potentially reducing complications and improving survival.
What could go wrong
This is a relatively small, early-stage trial (115 people) and the results may not apply to all patients. The procedure itself carries risks like bleeding or infection.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 115 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2026

Expected to finish

Oct 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

18 to 77 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    3 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • University Hospital Cologne

    RECRUITING

    Cologne, 50937, Germany

  • University Hospital Düsseldorf

    RECRUITING

    Düsseldorf, North Rhine-Westphalia, 40225, Germany

  • University Hospital Schleswig-Holstein, Campus Kiel

    RECRUITING

    Kiel, Schleswig-Holstein, 24105, Germany

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