The Door To Unloading with IMPELLA CP Pivotal Study
Are you eligible to participate in this study?
You may be eligible for this study if you meet the following criteria:
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Conditions: Coronary Artery Disease
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Age: Between 18 - 120 Years
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Gender: Male or Female
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Other Inclusion Criteria:
- First myocardial infarction
- Acute anterior STEMI according to the protocol
- Participants exhibits to the hospital between 1 - 5 hours of chest pain onset
- Participant will receive Primary percutaneous coronary intervention
- Participants or their LAR must provide written informed consent
You may not be eligible for this study if the following are true:
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- Transferred from an outside hospital (OSH) where invasive coronary procedure was attempted
- Unwitnessed cardiac arrest OR =30 minutes of CPR prior to enrollment OR any cardiac arrest with impairment in mental status, cognition, or any global or focal neurological deficit
- Administration of fibrinolytic therapy within 24 hours prior to enrollment
- Cardiogenic shock
- Inferior STEMI or suspected right ventricular failure
- Any contraindication or inability to Impella placement
- Severe aortic stenosis
- Acute cardiac mechanical complication
- Suspected or known pregnancy
- Suspected systemic active infection
- History or known hepatic insufficiency prior to catheterization
- On renal replacement therapy
- COPD with home oxygen therapy or on chronic steroid therapy
- Known or evidence of prior myocardial infarction
- History of heart failure
- Prior aortic valve surgery or TAVR
- Left bundle branch block (new or old
- History of stroke/TIA within the prior 3 months
- History of bleeding diathesis or known coagulopathy
- On systemic anticoagulation pre-procedure
- Undergoing MRI or use of gadolinium
- Heparin, pork, pork products or contrast media
- Receiving a drug-eluting stent
- Participation in the active treatment or follow-up phase of another clinical study of an investigational drug or device
- Has other medical, social, or psychological problems that, in the opinion of the Investigator, compromises the subject’s ability to give written informed consent and/or to comply with study procedures, including follow-up CMRs
If you are registered as a volunteer, please log in to contact the study team/express interest in this study.