(Pre-) CLINICAL STUDIES

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 DZHK20-BioVAT-HF trial.

***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%)

Therapeutic Goal:
- 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

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