Safety and Efficacy of Induced Pluripotent Stem Cell-derived Engineered Human Myocardium as Biological Ventricular Assist Tissue in Terminal Heart Failure (BioVAT-HF)
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ClinicalTrials.gov Identifier: NCT04396899 |
Recruitment Status :
Recruiting
First Posted : May 21, 2020
Last Update Posted : March 27, 2023
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Heart Failure | Biological: EHM implantation | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 53 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Safety and Efficacy of Induced Pluripotent Stem Cell-derived Engineered Human Myocardium as Biological Ventricular Assist Tissue in Terminal Heart Failure |
Actual Study Start Date : | February 3, 2020 |
Estimated Primary Completion Date : | March 2024 |
Estimated Study Completion Date : | October 2024 |
Arm | Intervention/treatment |
---|---|
EHM Implantation
All patients will receive EHM implant
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Biological: EHM implantation
Implantation of EHM on dysfunctional left or right ventricular myocardium in patients with HFrEF (EF <35%). |
- Target heart wall thickness [ Time Frame: 12 months ]Target heart wall thickness (HWT) as determined by high resolution echocardiography and/or CINE-mode MRI (17-segment model). Primary efficacy analyses are based on the changes in HWT between baseline and 2 weeks, 1 month, 3 months, 6 months and 12 months after implantation. To test for a time effect a one-way Repeated Measures ANOVA will be performed for the primary endpoint. In case of detecting a time effect this is followed by Dunnett-type pairwise comparisons to baseline using paired t-Tests. Due to the explorative character of the efficacy analysis testing will be performed at a 10% two-sided significance level. Mean differences will be reported along with 90% confidence intervals.
- Heart wall thickening fraction [ Time Frame: 12 months ]Heart wall thickening fraction (HWTF) as determined by high resolution echocardiography and/or CINE-mode MRI (17-segment model). Primary efficacy analyses are based on the changes in HWTF between baseline and 2 weeks, 1 month, 3 months, 6 months and 12 months after implantation. To test for a time effect a one-way Repeated Measures ANOVA will be performed for the primary endpoint. In case of detecting a time effect this is followed by Dunnett-type pairwise comparisons to baseline using paired t-Tests. Due to the explorative character of the efficacy analysis testing will be performed at a 10% two-sided significance level. Mean differences will be reported along with 90% confidence intervals.
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Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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 Criteria:
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04396899
Contact: Wolfram-Hubertus Zimmermann, Prof. | +49 551 / 3965781 | sekretariat.pharma@med.uni-goettingen.de | |
Contact: Florian Walker, Dr. | +49 551 / 3960825 | biovat@med.uni-goettingen.de |
Germany | |
University Medical Center Göttingen | Recruiting |
Göttingen, Lower Saxony, Germany, 37075 | |
Contact: Tim Seidler, Prof. | |
Herz- und Diabeteszentrum Nordrhein-Westfalen | Not yet recruiting |
Bad Oeynhausen, North Rhine-Westphalia, Germany, 32545 | |
Contact: Jan Gummert, Prof. | |
University Medical Center Schleswig-Holstein | Recruiting |
Lübeck, Schleswig-Holstein, Germany, 23562 | |
Contact: Stephan Ensminger, Prof. |
Principal Investigator: | Tim Seidler, Prof. | University Medical Center Goettingen | |
Study Director: | Wolfram-Hubertus Zimmermann, Prof. | University Medical Center Goettingen |
Responsible Party: | Karsten Gavenis, on behalf of Principal Investigator Prof. Seidler and Study Director Prof. Zimmermann, University Medical Center Goettingen |
ClinicalTrials.gov Identifier: | NCT04396899 |
Other Study ID Numbers: |
02289 |
First Posted: | May 21, 2020 Key Record Dates |
Last Update Posted: | March 27, 2023 |
Last Verified: | March 2023 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Heart Failure Heart Diseases Cardiovascular Diseases |