Abiomed Inc.
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 pres…
Inclusion Criteria: 1. Age ≥ 18 and \< 80 years 2. Subject or subject's legally authorized representative (LAR) has signed the Informed Consent Form 3. LVEF ≤ 40% 4. Subject is presenting with decompensated heart failure and meets at least two (2) of the following cardiogenic shock criteria: 1. Hypotension (sustained episode of systolic blood pressure ≤ 90 mmHg for at least 30 minutes or need for inotropic/vasoactive agents to maintain such blood pressure) 2. Hypoperfusion (physical sign(s) of organ hypoperfusion or serum lactate \>2 mmol/L) 3. Cardiac index (CI) \< 2.2 L/min/m2 det…
The intervention is Impella 5.5 with SmartAssist® support combined with protocolized guideline directed medical therapy (GDMT) and HF-CS best practices.