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New study tracks impella use in heart attack shock patients

NCT ID NCT06964685

Knowledge-focused Sponsor: Abiomed Inc. Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jul 07, 2026 · Updated 4 times

Summary

This study observes up to 350 patients who had a heart attack complicated by cardiogenic shock and received an Impella CP heart pump during artery-opening procedures. Researchers will track safety issues like major bleeding, limb problems, and kidney injury, as well as survival and heart-related events over one year. The goal is to understand how best practices with Impella affect outcomes in this critically ill group.

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 350 people

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

Started

Jul 2025

Expected to finish

Oct 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Who is studied

Only patients with AMICS who receive Impella CP as the first Impella device after cardiogenic shock onset will be included in the study.

Ages

18 years and older

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: * Acute myocardial infarction (AMI) of \<36 hours duration from symptom onset to cath lab arrival, confirmed by: * ECG and/or biomarker evidence of ST-segment elevation myocardial infarction (STEMI), STEMI equivalents, or new or presumed new left bundle branch block or * ECG and/or biomarker evidence of non-ST-segment elevation myocardial infarction (NSTEMI) and angiographic evidence of one or more culprit vessels * Cardiogenic shock confirmed by at least two of the following: * Tissue hypoperfusion, manifested by an arterial or venous blood lactate level ≥2.5 mmol/L or SvO2 \<55% in the presence of a PaO2 \> 90mmHg * Systolic blood pressure \<100 mmHg or need for vasoactive agents to maintain systolic blood pressure ≥100 mmHg * Hemodynamic criteria represented by a cardiac index of \<2.2 L/min/m\^2 or a cardiac power output ≤0.6 W * Cardiogenic shock that develops under one of the following conditions: * prior to primary PCI, with \<24 hours from the onset of shock to cath lab arrival, or * \<12 hours after initiating primary PCI * Patient was supported with Impella CP as the initial MCS device for cardiogenic shock * Age ≥18 years * Europe only: Subject or legally designated representative (LDR) or Independent Physician has provided written informed consent for participation in the observational study Exclusion Criteria: * Any contraindication listed in the Impella CP IFU if known to be present (i.e. mural thrombus in the left ventricle; presence of a mechanical aortic valve or heart constrictive device; aortic valve stenosis/calcification (equivalent to an orifice area of 0.6 cm2 or less); moderate to severe aortic insufficiency (echocardiographic assessment graded as ≥ +2); severe arterial disease precluding placement of the Impella system; presence of an atrial or ventricular septal defect (including post-infarct VSD); significant right heart failure; left ventricular rupture; cardiac tamponade; combined cardiorespiratory failure). * Shock principally due to a cause other than LV failure, including: * RV infarction, hypovolemia, anaphylaxis, hemorrhage, sepsis, myocarditis, pulmonary embolism, pneumothorax, or high cardiac output shock * Severe arrhythmias as the primary cause of low cardiac output, including acute bradyarrhythmias, tachyarrhythmias, or advanced heart block * Known mechanical complications of AMI that may cause cardiogenic shock such as free wall rupture, ventricular septal defect or papillary muscle rupture with acute mitral regurgitation * Procedural complication of the PCI that results in coronary perforation * Other mechanical circulatory support already in place for present indication, including intra-aortic balloon counter-pulsation or patients with Impella CP placement prior to transfer to the cath lab at the tertiary facility * Acute or chronic aortic dissection * Prior PCI at another institution for the present infarction * Thrombolytic therapy for the present infarction * Not obeying verbal commands after preadmission or in-hospital cardiac arrest, indicative of possible anoxic brain injury NOTE: * Non-intubated subjects: A positive and appropriate response to commands must be repeatable on at least two (2) instances to rule out reflex response to voice * Intubated subjects are excluded if: They were not following verbal commands immediately prior to intubation, or They were not clearly following verbal commands after intubation within 6 hours post-PCI * Infective endocarditis * Other severe, concomitant disease with limited life expectancy \<1 year (other than cardiogenic shock) * Participation in the active treatment or follow-up phase of another clinical study of an investigational drug or device that has not reached the timing of its primary endpoint

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Conditions

The condition(s) this trial relates to.

acute myocardial infarction cardiogenic shock

As listed by the trial registrant

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

Ami cardiogenic shock

How to take part

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

  1. The places running it

    18 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

  • Bethesda North Hospital

    RECRUITING

    Cincinnati, Ohio, 45242, United States

  • Brigham and Women's Hospital

    RECRUITING

    Boston, Massachusetts, 02115, United States

  • Cardiology Associates Research Group (St. Bernard's Hospital)

    RECRUITING

    Jonesboro, Arkansas, 72401, United States

  • Henry Ford Health System

    RECRUITING

    Detroit, Michigan, 48202, United States

  • Inova Fairfax

    RECRUITING

    Falls Church, Virginia, 22042, United States

  • Legacy Emanuel Medical Center

    RECRUITING

    Portland, Oregon, 97227, United States

  • Methodist Hospital

    RECRUITING

    San Antonio, Texas, 78229, United States

  • NCH Rooney Heart Institute

    RECRUITING

    Naples, Florida, 34102, United States

  • New Mexico Heart

    RECRUITING

    Albuquerque, New Mexico, 87102, United States

  • OSF Saint Francis

    RECRUITING

    Peoria, Illinois, 61637, United States

  • Parkwest Medical Center

    RECRUITING

    Knoxville, Tennessee, 37923, United States

  • Providence St. Vincent Medical Center

    RECRUITING

    Portland, Oregon, 97225, United States

  • Saint Francis Hospital

    RECRUITING

    Tulsa, Oklahoma, 74136, United States

  • St. Joseph Hospital Orange

    RECRUITING

    Orange, California, 92868, United States

  • Straub Benioff Medical Center

    RECRUITING

    Honolulu, Hawaii, 96813, United States

  • Texas Health Presbyterian Hospital Dallas

    RECRUITING

    Dallas, Texas, 75231, United States

  • Torrance Memorial Medical Center

    RECRUITING

    Torrance, California, 90505, United States

  • UTHealth Memorial Hermann

    RECRUITING

    Houston, Texas, 77030, United States