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
Key Powered Composite Secondary Efficacy Endpoint:
Compared between groups using Finkelstein- Schoenfeld statistic at 12 months after the randomization of the last enrolled subject. 1. Cardiovascular mortality 2. Cardiogenic shock at ≥24 hours after enrollment 3. LVAD or heart transplant 4. Heart failure (HF)-related hospitalization/urgent care visit 5. ICD or CRT placement 6. Infarct size, as a percent of LV mass \[Time Frame: 3-5 days\]
Time frame: 12 months after the randomization of the last enrolled subject
Key Secondary Safety Endpoint
Impella CP-related major bleeding or major vascular complications (compared to a pre-specified performance goals).
Time frame: 30 days
Powered Secondary Endpoint:
Infarct size as a percentage of area-at-risk (AAR)
Time frame: 3-5 days
Powered Secondary Endpoints:
Percent microvascular obstruction (%MVO)
Time frame: 3-5 days
Powered Secondary Endpoints:
Left ventricular end-systolic volume (LVESV)
Time frame: 6 months
Powered Secondary Endpoints:
Left ventricular end-diastolic volume (LVEDV)
Time frame: 6 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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
Powered Secondary Endpoints:
Left ventricular end-systolic volume index (LVESVi)
Time frame: 90 days
Powered Secondary Endpoints:
Left ventricular end-diastolic volume index (LVEDVi)
Time frame: 90 days
Powered Secondary Endpoints:
Ejection fraction (EF)
Time frame: 6 months