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

Launched by ABIOMED INC. · May 7, 2025

Keywords

ClinConnect Summary

The clinical trial titled "OASIS-AMICS" is studying the safety and effectiveness of a heart support device called Impella CP for patients experiencing a severe heart condition known as cardiogenic shock, which can occur during a heart attack. The goal is to see how well this device works when used alongside standard medical care during a procedure called percutaneous coronary intervention (PCI), which helps open blocked arteries. The trial will involve up to 250 patients who are in a critical state due to their heart condition, specifically those who have had a heart attack within the last 36 hours and are showing signs of serious heart distress.

To be eligible for this study, participants must be at least 18 years old and have experienced a heart attack with a specific set of symptoms, such as low blood pressure or poor blood circulation. Patients will be monitored for various safety issues, including serious bleeding and kidney problems, over the course of a year after receiving the Impella device. It’s important to note that the trial is not yet recruiting participants, but any patient meeting the criteria will be considered for inclusion after being treated in the hospital. If you or a loved one are facing this serious condition, this trial may provide additional treatment options and support.

Gender

ALL

Eligibility criteria

• 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) 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 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 within 12 hours after initiating primary PCI. Cardiogenic shock is confirmed by at least two of the following:
• • Peripheral signs of tissue hypoperfusion (arterial blood lactate ≥2.5 mmol/l or SvO2 \<55% with a normal PaO2)
• • 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/m2 or a cardiac power output ≤0.6 W
• • Patient received PCI to treat the AMI
• • Patient was supported with Impella CP as the initial MCS device for cardiogenic shock
• • Age ≥18 years
• 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).
• * 2. 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
• • 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
• • 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: May be included if:
• • They were following verbal commands immediately prior to intubation, or
• • They were clearly following verbal commands after intubation
• • 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