LVAD Versus GDMT in Ambulatory Advanced Heart Failure Patients (AMBU-VAD)

This is an interventional treatment trial for End-stage Heart Failure focused on measuring Heart Failure, End-stage, Not inotrope-dependent, Left Ventricular Assist Device, HeartMate 3 system, Heart Surgery, Guideline Directed Medical Therapy Read More

Inclusion Criteria:

1. All patients ≥18 years,

2. 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,
3. Having a health coverage,
4. Signed written informed consent,
5. Patient without any legal protection measure.

Exclusion Criteria:

1. Inotrope dependent patients or existence of ongoing mechanical circulatory support (MCS) in the last 30 days,
2. Right ventricular dysfunction (heart team consensus) with the expected need of Bi-VAD support,
3. Female patients currently pregnant or women of childbearing age who were not using contraception,
4. Active infection,
5. Irreversible end-organ dysfunction prior to LVAD implantation,
6. Contraindication to anti-coagulant or anti-platelet therapies,
7. History of any organ transplant prior to inclusion,
8. Psychiatric disease/disorder, irreversible cognitive dysfunction or psychosocial issues likely to impair compliance,
9. Frailty according to heart team,
10. Platelet count < 100,000 x 103/liter (<100,000/ml)
11. Body Surface Area (BSA) < 1.2 m2,
12. Any condition other than heart failure that could limit survival to less than 24 months,
13. Chronic renal insufficiency (GFR definitely <30 ml/min) or hepatic cirrhosis,
14. Participation in any other interventional clinical investigation.