Trial to Evaluate Safety And Effectiveness of Mechanical Circulatory Support in Patients With Advancing Heart Failure

[...] (ICF) prior to any clinical investigation-related procedure. LVEF ≤30% and Cardiac Index <≤ 2.25 L/min/m². Limited functional status as demonstrated by 6MWT <≤ 300350 m due to HF related reasons. OR peak VO2 ≤ 14 mL/kg/min (or <50% of predicted peak VO2 value) NYHA Class IIIB or NYHA Class IV Subject has ≥ 1 Heart Failure Hospitalization in the last 12 months. Subject is already implanted with a CardioMEMS PA Sensor OR willing to undergo a CardioMEMS PA Sensor implant. Subject is willing and able to be implanted with the HM3 LV [...] or at least 30 of the last 90 days. mean PAP ≥ 30 mmHg. The patien [...] [...]

FreedomRate fromof majorSafety Outcomes at 1-year All adverse events (MAEincluding all strokes) inregardless theof HM3 groupseverity

[...] dent HF patients. The objectives of the Randomized Arm are 1) Demonstrate improvement in survival when non-inotrope dependent advanced HF patients with elevated mean PAP are treated with the HM3 compared to being managed on medical therapy alone; and 2) To establish an objective disease-state criteria to trigger referral for a HM3 LVAS and 2) Demonstrate improvement in survival when non-inotrope dependent advanced HF patients are treated with the HM3 LVAS compared to being managed on medical therapy alone. The TEAM-HF Single Arm Registry is a prospective, single-a [...] ptimization. The objective of [...]