The BioVAT-HF Study
Safety and Efficacy of Induced Pluripotent Stem Cell-derived Engineered Human Myocardium as Biological Ventricular Assist Tissue in Terminal Heart Failure (BioVAT-HF)
Sponsor: University Medical Center Goettingen with support from the German Center for Cardiovcasular Research (DZHK) and Repairon GmbH.
The trial is investigating the hypothesis that cardiomyocyte implantation via engineered heart muscle (EHM) results in sustainable remuscularization and biological enhancement of myocardial performance in patients with advanced heart failure. The patient target population comprises patients with reduced ejection fraction (HFrEF; EF: ≤35%) and NYHA III/IV despite optimal medical therapy according to the most recent guidelines.
Primary Outcome Measures:
2. Target heart wall thickness (HWT) and thickening fraction (HWTF) as a measure for implant functionality
3. Hospitalization for Heart Failure
4. Global heart function
5. Quality of Life
Phase I/II open label, non-randomized, multi-center early clinical trial with adaptive study design