The purpose of this research study is to evaluate whether using the the IMPELLA® CP System temporary circulatory assist device for 30 minutes prior to a catheterization procedure has the potential to reduce the damage to the heart caused by a heart attack, compared to the current standard of care.
To demonstrate the safety and effectiveness of primary Left Ventricular unloading and a thirty-minutes delay to reperfusion vs. current standard of care in reducing infarct size and heart failure-related clinical events in patients presenting with anterior ST-Elevation Myocardial Infarction.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
527
Subjects randomized to the experimental arm, will undergo Impella CP® placement through a femoral arterial sheath and the Impella device will be activated to unload the left ventricle.
Infarct Size
Infarct size normalized to the left ventricular mass, evaluated using Cardiac Magnetic Resonance (CMR) imaging
Time frame: 3-5 days post-procedure
Infarct Size, as a percent of Left Ventricular Mass
Efficacy- Composite clinical secondary endpoint, Compared between groups in a hierarchical order using the Finkelstein-Schoenfeld statistic.
Time frame: 3-5 days
Impella CP® related Major Bleeding and Major Vascular complications
Efficacy (Cardiogenic Shock)- Composite clinical secondary endpoint. Compared between groups in a hierarchical order using the Finkelstein-Schoenfeld statistic. Secondary Safety (Major Bleeding and Vascular Complications); with pre-specified performance goals.
Time frame: 30 Days
Cardiogenic Shock, CV mortality, Heart Failure, LVAD or Heart Transplant and ICD or CRT Placement
Efficacy- Composite clinical secondary endpoint. Compared between groups in a hierarchical order using the Finkelstein-Schoenfeld statistic.
Time frame: 12 Months
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University of Alabama at Birmingham
Birmingham, Alabama, United States
HonorHealth Research Institute
Scottsdale, Arizona, United States
The University of Arizona
Tucson, Arizona, United States
Emanate Health Intercommunity Hospital / Valley Clinical Trials, Inc.
Covina, California, United States
Riverside Community Hospital
Riverside, California, United States
St. Anthony Hospital
Lakewood, Colorado, United States
Hartford Health Care
Hartford, Connecticut, United States
Christiana Care Health Services
Newark, Delaware, United States
George Washington University
Washington D.C., District of Columbia, United States
BayCare Cardiology - Morton Plant Hospital
Clearwater, Florida, United States
...and 53 more locations