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.
Age ≥ 18 and < 80 years
Subject has signed the Informed Consent Form. If the subject has been enrolled via an LAR, the subject must provide assent, the assent will be documented.
LVEF ≤ 40%
Sustained episode of systolic blood pressure ≤ 90 mmHg for at least 30 minutes or need for vasoactive agents to maintain such blood pressure.
Drug allergies or hypersensitivities* to HF GDMT medications, unless alternative can be identified.
Known bilateral renal artery stenosis
Type 1 diabetes
2o or 3o AV block, unless pacemaker is in place
Abiomed Inc.
Lead sponsor
Johnson & Johnson
Collaborator