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Observational Study of Impella® in Heart Attack with Cardiogenic Shock

This study is looking at the safety of using a device called Impella® CP in patients who have had a severe heart attack (acute myocardial infarction or AMI) and are also experiencing cardiogenic shock. Cardiogenic shock means your heart can't pump enough blood to meet your body's needs. The study will observe up to 350 patients who receive the Impella CP device and are cared for using standard medical practices. To join, you must be at least 18 years old, have had a heart attack within 36 hours of symptoms starting, and be experiencing cardiogenic shock. The main goal is to track any safety issues that happen while you are in the hospital, typically for about 15 days.

Study design
This is an observational study, meaning researchers will watch and collect information from up to 350 patients. It is not a randomized trial where you might receive different treatments.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Safety will be measured for all in-hospital events through discharge, which is an average of 15 days.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06964685

Assessment of Support With Impella® Best Practices in Acute Myocardial Infarction Complicated by Cardiogenic Shock

Recruiting
Not specifiedAges 18+Observational
Abiomed Inc.
~350 participants
Updated 2026-07-06 on ClinicalTrials.gov
What's tested:Impella

At a glance

Recruiting sites
18 of 18 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Composite Safety
Measured over All in-hospital events through discharge, an average of 15 days

Conditions

AMI Cardiogenic Shock

Explore related trials

Acute Myocardial InfarctionCardiogenic Shock

NCT06964685

Where you'd take part

This study runs at 18 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Bethesda North Hospital

    Cincinnati, Ohiono site contact published

    Recruiting

  • Brigham and Women's Hospital

    Boston, Massachusettsno site contact published

    Recruiting

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

    Jonesboro, Arkansasno site contact published

    Recruiting

  • Henry Ford Health System

    Detroit, Michiganno site contact published

    Recruiting

  • Inova Fairfax

    Falls Church, Virginiano site contact published

    Recruiting

  • Legacy Emanuel Medical Center

    Portland, Oregonno site contact published

    Recruiting

  • Methodist Hospital

    San Antonio, Texasno site contact published

    Recruiting

  • NCH Rooney Heart Institute

    Naples, Floridano site contact published

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

Sameera Dasari, PhD
[email protected]
978-914-8882
Email the study team

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Composite SafetyAll in-hospital events through discharge, an average of 15 days

    Composite safety endpoint (major bleeding, acute limb ischemia, or acute kidney injury requiring renal replacement therapy)