The PROTECT IV Trial (NCT04763200)

The PROTECT IV Trial (NCT04763200)

Impella®-Supported PCI in High-Risk Patients with Complex Coronary Artery Disease and Reduced Left Ventricular Function: The Protect IV Trial

The purpose of this study is to assess if using the Impella® CP (or Impella® 2.5) device during high-risk PCI in patients with reduced left-sided heart function will result in an improvement in symptoms, heart function, and health after a heart procedure compared to the current standard of care.

PI: Dr. Samar Sheth

Sponsor: ABIOMED

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Eligibility Requirements
– Age ≥18 years and ≤90 years
– Subject has Chronic Coronary Syndrome or NSTEMI with an LVEF ≤40%
OR
– Subject has STEMI ≥24 hours and <30 days after symptom onset with an LVEF ≤30%
– Local heart team (interventional cardiologist and cardiac surgeon) has determined that PCI is indicated and is the most appropriate management for the patient

* Please contact a member of the study team for full eligibility requirements.