Early versus emergency left ventricular assist device implantation in patients awaiting cardiac transplantation (VAD-DZHK3)

ID

NCT02387112

Status

Active

DZG

DZHK

Start date

05/02/2015

Parameters

Inclusion criteria
  • Patient (male or female) eligible for heart transplantation and accepted in T Status (transplantable) on the waiting list Age 18 to 65 years Signed informed consent >30% 1-year mortality with the Seattle Heart Failure Model (SHFM) or at least three of the following criteria (a) to (f): cardiac index (CI) <2.5 l/min/m² pulmonary capillary wedge pressure >15 mmHg maximal oxygen uptake (VO2max) ≤10.0 ml/kg/min or ≤12.0 ml/kg/min in patients intolerant of a ß-blocker ratio of minute ventilation (VE) to carbon dioxide (VCO2) production (VE/VCO2) slope of >35 at least two hospitalizations for heart failure within the previous 12 months documented increase of brain natriuretic peptide (BNP) or NTproBNP levels despite optimal medical therapy
Exclusion criteria
  • Listing for transplantation of other organs in addition to heart Previous cardiac surgeries (other than pacemaker or ICD surgeries) Contraindications to assist device implantation (e.g. mechanical aortic valve
  • aortic insufficiency) Contraindications to anticoagulation Expected need for a right ventricular assist device/biventricular support expected (e.g. due to tricuspid valve insufficiency grade 3+
  • right ventricular ratio short/long axis ≥0.6
  • ratio of right to left ventricular end-diastolic diameter (RVEDD/LVEDD) >0.72
  • restrictive cardiomyopathy) Presence of catecholamine support or intra-aortic balloon counterpulsation (IABP) Overt infections Fixed pulmonary hypertension (i.e. pulmonary arterial pressure (PAP) >60 mmHg and mean transpulmonary gradient (TPG) >15 mmHg or pulmonary vascular resistance (PVR) >6 Wood units despite optimal medical treatment) Renal insufficiency (glomerular filtration rate (GFR) <30ml/min or need for hemodialysis or hemofiltration) Significant coagulopathies Systemic lupus erythematosus
  • sarcoid
  • or amyloidosis that has multisystem involvement and is still active Drug abuse and/or alcohol abuse Incompliance Elevated panel reactivity levels of >50 % Pregnancy or breast feeding in women Participation in other investigational trials