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Heart FailurePhase 1/2BioVAT-HFNCT04396899

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

A Phase 1/2 study testing EHM implantation in people with Heart Failure, run by University Medical Center Goettingen at 3 sites in Germany.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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 Assist Tissue" or BioVAT), results in sustainable remuscularization and biological enhancement of myocardial… Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Heart Failure
What is being tested?
EHM implantation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
53 participants
Where
3 sitesGermany
Study dates
3 Feb 2020to Dec 2027
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Symptomatic heart failure (NYHA II-IV) with reduced ejection fraction (HFrEF with LVEF ≤35%) as assessed by echocardiography.
  • Patients on guideline-directed medical therapy
  • NT-proBNP >300 pg/mL for patients in sinus rhythm or >900 pg/mL if in atrial fibrillation
  • History of previous heart failure hospitalization in the past 12 months
  • At least one hypo- or dyskinetic segment or dilated heart chamber to demark the implant target area
  • (A) Stable disease condition allowing for an elective left-lateral mini-thoracotomy (for LV applications) or (B) open-chest surgery (for RV applications) for a clinically indicated intervention on the LV (e.g., coronary bypass surgery, valve repair, mechanical circulatory support device implantation) with concomitant RV dysfunction, diagnosed using the Tricuspid Annular Plane Systolic Excursion (TAPSE) index <16 mm (Rudski et al. 2010).
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  • 18-80 years of age
  • 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.

Who cannot join

  • Contraindication to immunosuppressive drugs (e.g. known history of unresolved cancer, hepatitis B/C, HIV, HTLV1)
  • Contraindication to TachoSil® (e.g. hypersensitivity to human fibrinogen, human thrombin, horse collagen, human albumin, Riboflavin, Natriumchloride, Natriumcitrate, L-Arginin-Hydrochloride)
  • Hypertrophic cardiomyopathy (HCM)
  • Terminal kidney failure (stage 4; GFR <30 ml/min) at the time of enrolment
  • Terminal liver failure (Child-Pugh stage C; score >10) at the time of enrolment
  • History of disabling stroke
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  • Reduced life expectancy in the short term due to non-cardiac disease
  • Any condition that excludes adherence to study protocol (in particular lack of adherence to prescribed medication)
  • Simultaneous participation in another interventional trial
  • Pregnant or breastfeeding females
  • Known or suspected alcohol and/or drug abuse

Trial locations and contacts

3 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Wolfram-Hubertus Zimmermann, Prof. contact

+49 551 / 3965781

sekretariat.pharma@med.uni-goettingen.de

Florian Walker, Dr. contact

+49 551 / 3960825

biovat@med.uni-goettingen.de

Germany3 sites, 3 recruiting

  • Herz- und Diabeteszentrum Nordrhein-Westfalen

    Bad Oeynhausen, North Rhine-Westphalia, 32545

    Jan Gummert, Prof.

    Not yet recruiting

  • University Medical Center Göttingen

    Göttingen, Lower Saxony, 37075

    Tim Seidler, Prof.

    Recruiting

  • University Medical Center Schleswig-Holstein

    Lübeck, Schleswig-Holstein, 23562

    Stephan Ensminger, Prof.

    Recruiting

Other trials in Germany

About this study

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 Assist Tissue" or BioVAT), results in sustainable remuscularization and biological enhancement of myocardial performance in the failing heart. EHM are constructed from defined mixtures of induced pluripotent stem cell (iPSC)-derived cardiomyocytes and stromal cells in a bovine collagen type I hydrogel. Comprehensive preclinical testing confirmed the rationale for the clinical translation of the myocardial remuscularization strategy by EHM implantation. The patient target population for EHM therapy is patients suffering from advanced heart failure with reduced ejection fraction (HFrEF; EF: ≤35%) and no realistic option for heart transplantation.

Conditions
Heart Failure
Being tested
EHM implantation
Medical subject headings
Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EHM implantationBiological

    Implantation of EHM on dysfunctional left or right ventricular myocardium in patients with HFrEF (EF <35%).

Study groups in NCT04396899
Study groupRoleWhat they receive
EHM ImplantationOtherAll patients will receive EHM implant
Receives: Biological: EHM implantation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Adverse events

    Number of Adverse events related to the procedure, including in particular arrhythmic events and worsening of disease progression within 28 days (Part A) and the whole study duration (Part B)

    Measured: 12 months

  2. Heart target heart wall thickness

    Change of target heart wall thickness (TWTh in mm) Echo or cCT or cMRI

    Measured: 12 months

  3. LV/RV-ejection fraction

    Change of LV/RV-ejection fraction (LV/RV-EF in %) Echo or cCT or cMRI

    Measured: 12 months

  4. Patient reported outcome

    Patient reported outcome Change of KCCQ-23 OSS (Overall Summary Score)

    Measured: 12 months

Secondary outcomes (18)

  1. Major adverse cardiac events

    Frequency of major adverse cardiac events (MACE; non-fatal myocardial infarction, non-fatal stroke, and cardiovascular death)

    Measured: 12 months

  2. Arrhythmic events

    Frequency and severity of arrhythmic events

    Measured: 12 months

  3. Immune rejection

    Incidence of immune rejection (DSA, CK/CK-MB, hs-cTnT, circulating cell-free allograft DNA)

    Measured: 12 months

  4. Mechanical perturbation of ventricular function

    Incidence of mechanical perturbation of ventricular function by EHM graft

    Measured: 12 months

  5. Recurrent hospitalizations for heart failure

    Frequency of recurrent hospitalizations for heart failure

    Measured: 12 months

  6. Mechanical circulatory assist device implantation

    Time to mechanical circulatory assist device implantation

    Measured: 12 months

  7. Heart transplantation

    Time to heart transplantation.

    Measured: 12 months

  8. Cardiopulmonary stress testing (VO2max)

    Functional status in patients as determined by cardiopulmonary stress testing (VO2max)

    Measured: 12 months

  9. Cardiopulmonary stress testing six-minute walk test (6MWT)

    Functional status in patients as determined by cardiopulmonary stress testing six-minute walk test (6MWT) - distance (in m)

    Measured: 12 months

  10. Hand-grip strength

    Functional status in patients as determined by and hand-grip strength measurements

    Measured: 12 months

  11. NYHA classification

    Patient reported outcomes assessed by NYHA classification

    Measured: 12 months

  12. Quality of life score (EQ-5D-5L)

    Patient reported outcomes assessed by quality of life score (EQ-5D-5L)

    Measured: 12 months

  13. Hospital Anxiety and Depression Scale (HADS)

    Patient reported outcomes assessed by study adherence motivation according to following questionnaire: HADS

    Measured: 12 months

  14. Mortality

    All-cause and cardiovascular mortality

    Measured: 12 months

  15. Montreal Cognitive Assessment (MoCA)

    Patient reported outcomes assessed by study adherence motivation according to following questionnaire: MoCA

    Measured: 12 months

  16. Medication adherence

    Patient reported outcomes assessed by study adherence motivation according to medication adherence questionnaire.

    Measured: 12 months

  17. Brief Illness Perception Questionnaire (B-IPQ)

    Patient reported outcomes assessed by study adherence motivation according to following questionnaire: B-IPQ

    Measured: 12 months

  18. Treatment Expectation Questionnaire (TEX-Q)

    Patient reported outcomes assessed by study adherence motivation according to following questionnaire: TEX-Q

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 May 2020
  2. Study start3 Feb 2020
  3. Primary completionDec 2027 (estimated)
  4. Study completionDec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
53 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04396899
Sponsor's protocol ID
02289
Acronym
BioVAT-HF
Status last verified
Feb 2026
First submitted
11 May 2020
Last updated
20 Feb 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Zimmermann WH, Ensminger S, Kutschka I, Paitazoglou C, Seidler T, Brandenburg S, Anker SD, Bader N, Bergau L, Bremmer F, Diogo PG, Eitel I, Fujita B, Gerecke B, Hasenfuss G, Hellenkamp K, Hermann-Lingen C, Jebran AF, Jurczyk D, Knaus R, Legler T, Lotz J, Placzek M, Puhler T, Riggert J, Sadlonova M, Saraei R, Strobel P, Tiburcy M, Ullrich C, Voigt JU, Walker F, Wollnik B, Yigit G, Friede T; BioVAT-HF Investigators. Stem-Cell-Derived Biologic Ventricular Assist Tissue in Heart Failure. N Engl J Med. 2026 May 28;394(20):1991-2001. doi: 10.1056/NEJMoa2513525.

    PubMed 42202318

  • Montague EC, Ozcan B, Sefton E, Wulkan F, Alibhai FJ, Laflamme MA. Human pluripotent stem cell-based cardiac repair: Lessons learned and challenges ahead. Adv Drug Deliv Rev. 2025 Jul;222:115594. doi: 10.1016/j.addr.2025.115594. Epub 2025 May 5.

    PubMed 40334814

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing EHM implantation in people with Heart Failure, run by University Medical Center Goettingen at 3 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 20 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Wolfram-Hubertus Zimmermann, Prof. (+49 551 / 3965781, sekretariat.pharma@med.uni-goettingen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adverse events (time frame: 12 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04396899, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2026.

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