LVAD Versus GDMT in Ambulatory Advanced Heart Failure Patients

Prior treatment

• Irreversible end-organ dysfunction prior to LVAD implantation,
• History of any organ transplant prior to inclusion,

Other illness

• Right ventricular dysfunction (heart team consensus) with the expected need of Bi-VAD support,
• Active infection,
• Psychiatric disease/disorder, irreversible cognitive dysfunction or psychosocial issues likely to impair compliance,
• Frailty according to heart team,
• Any condition other than heart failure that could limit survival to less than 24 months,

Lab values

• Contraindication to anti-coagulant or anti-platelet therapies,
• Platelet count \< 100,000 x 103/liter (\<100,000/ml)
• Chronic renal insufficiency (GFR definitely \<30 ml/min) or hepatic cirrhosis,

Age

• Female patients currently pregnant or women of childbearing age who were not using contraception,

Other

• Inotrope dependent patients or existence of ongoing mechanical circulatory support (MCS) in the last 30 days,
• Body Surface Area (BSA) \< 1.2 m2,
• Participation in any other interventional clinical investigation.

• All patients ≥18 years,
• End-stage heart failure, evaluated by the local Heart Team, defined as:
  • Left ventricular ejection fraction ≤ 35% within 1 week prior to randomization and
  • Cardiac Index \< 2.2 L/min/m² by hemodynamic use within 1 month prior to randomization or VO2 max \< 14 ml/kg/min (or \<50% of predicted VO2max) within 1 month prior to randomization OR low 6-min walking test (\< 420 m) within 1 month prior to randomization or ≥ 2 hospitalizations for heart failure in the past year and
  • NYHA III-IV (INTERMACS profile 4-6) and and
  • Receiving medical management with optimal doses of betablockers, Angiotensin-Converting-Enzyme-inhibitors or Angiotensin II Receptor Blockers or angiotensin receptor neprilysin inhibitor (if eligible) and Mineralocorticoid Receptor Antagonists and Sodium-GLucose co-Transporter-2 (SGLT2) inhibitors for at least 45 days if tolerated according to guideline at maximal tolerated dose (if maximal HF drug dosage is not reached the investigators will have to explain reason behind not maximal dosage).
  • Receiving Cardiac Resynchronization Therapy and or Implantable Cardioverter Defibrillators if indicated for at least 45 days and
  • No mechanical circulatory support or inotrope therapy since \> 30 days,
• Having a health coverage,
• Signed written informed consent,
• Patient without any legal protection measure.