Status:
RECRUITING
Safety and Efficacy of Induced Pluripotent Stem Cell-derived Engineered Human Myocardium as Biological Ventricular Assist Tissue in Terminal Heart Failure
Lead Sponsor:
University Medical Center Goettingen
Collaborating Sponsors:
Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)
University Medical Center Freiburg
Conditions:
Heart Failure
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
PHASE2
Brief Summary
The BioVAT-HF trial will test the hypothesis that cardiomyocyte implantation via engineered heart muscle (EHM), the proposed investigational medicinal product (IMP; designated "Biological Ventricular ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 3 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
53 Patients enrolled
Trial Details
Trial ID
NCT04396899
Start Date
February 3 2020
End Date
December 1 2027
Last Update
May 2 2025
Active Locations (3)
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1
University Medical Center Göttingen
Göttingen, Lower Saxony, Germany, 37075
2
Herz- und Diabeteszentrum Nordrhein-Westfalen
Bad Oeynhausen, North Rhine-Westphalia, Germany, 32545
3
University Medical Center Schleswig-Holstein
Lübeck, Schleswig-Holstein, Germany, 23562