Biological Ventricular Assist Tissue in Heart Failure (BioVAT-HF)
* German program: Developed in agreement with multi-step advice obtained from Paul-Ehrlich-Institute (PEI) with anticipated first patient treated in Q1/2020.
** EU program: To be be initiated with European Medicines Agency (EMA) after initial clinical data has been obtained from the
***US program: In development according to advice obtained from Food & Drug Administration (FDA) during a pre-IND meeting in November 2018.
DZHK20.BioVAT-HF: Clinical trial supported by the DZHK (German Center for Cardiovascular Research) Early Clinical Study Program.
Target Patient Population:
- Patients with endstage heart failure (NYHA III/IV) with reduced ejection fraction (<35%)
- Improvement of outcome by remuscularization of the failing heart Study Objective:
- Assessment of safety and efficacy after surgical targeting EHM to the target heart hypokinetic wall