Impella® Device for Patients with Complex Heart Disease
Impella-Supported PCI in High-Risk Patients With Comple Coronary Artery Disease and Reduced Left Ventricular Function: The PROTECT IV Trial
This study is for participants diagnosed with complex heart disease and reduce left heart function and involves a heart procedure called a Percutaneous Coronary Intervention (PCI). Participants may be eligible for this study if their doctor has determined that an Impella® device could be beneficial during the PCI procedure. The goal of this study is to assess if using the Impella® device during high-risk PCI procedures will result in an improvement in symptoms, heart function and health after the heart procedure compared to the current standard of care.
The Impella® device works by placing a small pump through blood vessels and into the left pumping chamber of the heart. The pump is like a tiny propeller and assists the heart by helping to move blood throughout the body. This device is typically removed after about four to six hours.
Participants will be asked to return up to seven times for follow-up visits after hospital discharge. Each visit will last about 1 to 2 hours. These visits will occur post-discharge at 30 days, 60 days, 90 days, 6 months, 1 year, 2 years and 3 years.
To demonstrate that in high-risk patients with comple CAD and reduced leftventricular function undergoing PCI, PCI with Impella MCS is superior to PCIwithout Impella MCS in reducing the composite rate of all-cause death,stroke, durable LVAD implant or heart transplant, MI or hospitalization forcardiovascular causes at 3-year follow-up.
1. Between the ages of 18 - 90 years old
2. Clinical presentation and baseline left ventricular function are as follows (either 2A or 2B must be present):
2A. Subject has CCS or NSTEMI with an LVEF ≤40%
2B. Subject has STEMI ≥24 hours and <30 days after symptom onset with an LVEF ≤30%
3. Local heart team (interventional cardiologist and cardiac surgeon) has determined that PCI is indicated and is the most appropriate
management for the patient
4. Complex PCI will be performed
5. Subject or legal guardian (permitted at US sites only) agrees to randomization and to follow all study procedures and provides informed written consent
Let us know how the study team can reach you. If you do not hear back within 2 business days, reach out to the study team directly at the
contact information above or email email@example.com and someone will assist you.
Your information will be shared only with the research study team for recruitment purposes and designated CTSI personnel for project quality
assurance and will remain confidential. Your information will be stored indefinitely. Should you no longer want this information to be provided
in the aforementioned ways, please contact firstname.lastname@example.org.