Safety and Efficacy of Induced Pluripotent Stem Cell-derived Engineered Human Myocardium as Biological Ventricular Assist Tissue in Terminal Heart Failure (BioVAT-DZHK20)

ID

NCT04396899

Status

Active

DZG

DZHK

Start date

02/03/2020

Parameters

Inclusion criteria
  • HFrEF (EF ≤ 35%) as assessed by high-resolution echocardiography or MRI No realistic chance or not eligible for heart transplantation At least one hypo- or dyskinetic segment to demark the implant target area Stable disease condition allowing for an elective left-lateral mini-thoracotomy (for LV applications) or open-chest surgery (for RV applications) for a clinically indicated intervention on the LV (e.g.
  • coronary bypass surgery
  • valve repair) with concomitant RV dysfunction
  • diagnosed using the Tricuspid Annular Plane Systolic Excursion (TAPSE) index <16 mm (Rudski et al. 2010). 18-80 years of age Previous implantation of an ICD or CRT-D with event recorder New York Heart Association (NYHA) Class III or IV under optimal medical therapy Willingness and ability to give written informed consent Female subjects of childbearing potential must agree to use acceptable method(s) of contraception for the full study duration.
Exclusion criteria
  • Contraindication to immunosuppressive drugs (e.g. known history of unresolved cancer
  • hepatitis B/C
  • HIV
  • HTLV1) Alloimmunisation against EHM implant cells Hypertrophic cardiomyopathy (HCM) Terminal kidney failure (stage 4
  • GFR <30 ml/min) Terminal liver failure Autoimmune disease History of stroke Reduced life expectancy in the short term due to non-cardiac disease Simultaneous participation in another interventional trial Pregnant or breastfeeding females Known or suspected alcohol and/or drug abuse