The study will evaluate the impact of a combined device-drug strategy with Impella 5.5 with best practices and optimized GDMT on heart recovery outcomes in patients with decompensated heart failure and cardiogenic shock.
This is a prospective, single arm, multi-center, post-market, on-label study. For patients presenting with cardiogenic shock in the setting of cardiomyopathy, including peripartum cardiomyopathy, or myocarditis (also known as decompensated heart failure complicated with cardiogenic shock, commonly referred to as heart failure-related cardiogenic shock, HF-CS, including both acute-on-chronic and de novo presentations) as a result of isolated left ventricular failure that is not responsive to optimal medical management and conventional treatment measures (including volume loading and use of pressors and inotropes, with or without IABP), an intentional device-supported strategy with Impella 5.5™ for optimization of guideline-directed medical therapy (GDMT) combined with best practices improves outcomes over standard of care.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
250
The intervention is Impella 5.5 with SmartAssist® support combined with protocolized guideline directed medical therapy (GDMT) and HF-CS best practices.
Tampa General Hospital
Tampa, Florida, United States
Ascension St. Vincent
Indianapolis, Indiana, United States
Composite of all-cause death, HF hospitalization, and heart replacement (heart transplantation or durable LVAD implantation)
Time frame: Timeframe: 180-days post-enrollment
Composite of all-cause death and heart replacement
Time frame: 90-days, 180-days, 1-year post-enrollment
Composite of all-cause death, HF hospitalization, and heart replacement
Time frame: 90-days, 1-year post-enrollment
All-cause mortality
Time frame: Hospital Discharge (within 24 hours) , 90-days, 180-days, 1-year post-enrollment
Cardiovascular mortality
Time frame: Hospital Discharge (within 24 hours), 90-days, 180-days, 1-year post-enrollment
Worsening heart failure
HF hospitalization or urgent HF visit
Time frame: 90-days, 180-days, 1-year post-enrollment
Composite of all-cause death and worsening heart failure
Time frame: 90-days, 180-days, 1-year post-enrollment
Non-HF cardiovascular hospitalization
Time frame: 90-days, 180-days, 1-year post-enrollment
All cardiovascular hospitalization
Time frame: 90-days, 180-days, 1-year post-enrollment
Composite of all-cause death and all cardiovascular hospitalization
Time frame: 90-days, 180-days, 1-year post-enrollment
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Abbott Northwestern
Minneapolis, Minnesota, United States
Barnes Jewish
St Louis, Missouri, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
Rutgers-Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States
Atrium Health
Charlotte, North Carolina, United States
Duke University
Durham, North Carolina, United States
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, United States
University of Pennsylvania Health System
Philadelphia, Pennsylvania, United States
...and 5 more locations
Rate of major device-related adverse events
The composite rate of any of the following device-related serious adverse events: 1. Major vascular access site complication 2. Major hemolysis 3. Bleeding, defined as MCS-ARC Type 3 or higher 4. Structural complication requiring repair 5. Stroke
Time frame: Hospital Discharge (within 24 hours), 30-days post-enrollment
Subjects achieving indicated GDMT treatment
Achieving any dose of all four classes
Time frame: Hospital Discharge(within 24 hours), 90-days, 180-days post-enrollment
% of Subjects achieving optimized GDMT treatment
Achieving at least 50% of the target dose of all four classes
Time frame: 90-days and 180-days post-enrollment
Modified Heart Failure Collaboratory (mHFC) score
Defined by HFC in 2022. Improvement from baseline
Time frame: Hospital Discharge(within 24 hours), 90-days, 180-days post-enrollment
Rate of GDMT-Related Serious Adverse Events
The composite rate of any of the following GDMT-related serious adverse events: 1. Recurrence or worsening shock; symptomatic hypotension requiring admission 2. Bradycardia requiring treatment 3. Hyperkalemia requiring intervention 4. Ketoacidosis requiring treatment 5. Need for new renal replacement therapy (RRT)
Time frame: Hospital Discharge (within 24 hours), 90-days, and 180-days post-enrollment
Quality of life assessed by EQ-5D
improvement from baseline
Time frame: 180-days and 1-year post-discharge
6-Minute Walk Test Distance
improvement from baseline
Time frame: 180-days and 1-year post-discharge
Change in LVEF from baseline
Time frame: 180-days post-discharge
Change in LVEDD from baseline
Time frame: 180-days post-discharge
Change in NYHA HF Class from baseline
Time frame: 180-days post-discharge
Change in HF biomarker
NT-proBNP from baseline
Time frame: Hospital Discharge (within 24 hours), 30-days, and 90-days post-discharge