TAVI4Life | A lifelong transcatheter aortic valve prosthesis

Summary
Transcatheter aortic valve implantation (TAVI) techniques have revolutionized the therapy options for valvular heart disease. Initially developed for elderly high-risk patients, TAVI is being extended to younger patients and may become a first-line treatment in the near future.
However, the available bioprostheses for TAVI are prone to degeneration, and patients may thus require multiple re-interventions, significantly affecting their life quality. To date, a native-analogous TAVI prosthesis with in-situ remodeling capacity does not exist. Tissue engineered (TE) heart valves represent a potential solution, but are not yet suitable for high-pressure applications and lack clinical translation because of uncontrolled in-vivo remodeling, impairing their long-term functionality.
In the TAVI4Life project, I aim to develop and validate a novel TAVI prosthesis for young patients with the unique ability to transform into a fully autologous valve within the body and last for life. This project will go far beyond previous TE concepts by engineering a novel decellularized human ECM and a bioresorbable stent and applying an unconventional bioengineering approach combining in-vitro, in-silico, and in-vivo TE methods. First, I will engineer and characterize a clinical-grade ECM for high-pressure conditions and test patient-specific immuno- and hemocompatibility profile (in-vitro). Next, using computational modeling, I will design and develop a bioresorbable stent and implement an analytical valve design to develop the transcatheter prosthesis (in-silico). Finally, I will evaluate valve performance and remodeling in a preclinical large animal model (in-vivo). This highly multidisciplinary approach will lead to a valve prosthesis that lasts for life, as guided in-situ tissue remodeling will enable their long-term performance. The clinical impact will be enormous as, particularly for young patients, the TAVI4Life will significantly enhance their life expectancy and quality of life.
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More information & hyperlinks
Web resources: https://cordis.europa.eu/project/id/852814
Start date: 01-10-2020
End date: 30-09-2025
Total budget - Public funding: 1 499 375,00 Euro - 1 499 375,00 Euro
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Original description

Transcatheter aortic valve implantation (TAVI) techniques have revolutionized the therapy options for valvular heart disease. Initially developed for elderly high-risk patients, TAVI is being extended to younger patients and may become a first-line treatment in the near future.
However, the available bioprostheses for TAVI are prone to degeneration, and patients may thus require multiple re-interventions, significantly affecting their life quality. To date, a native-analogous TAVI prosthesis with in-situ remodeling capacity does not exist. Tissue engineered (TE) heart valves represent a potential solution, but are not yet suitable for high-pressure applications and lack clinical translation because of uncontrolled in-vivo remodeling, impairing their long-term functionality.
In the TAVI4Life project, I aim to develop and validate a novel TAVI prosthesis for young patients with the unique ability to transform into a fully autologous valve within the body and last for life. This project will go far beyond previous TE concepts by engineering a novel decellularized human ECM and a bioresorbable stent and applying an unconventional bioengineering approach combining in-vitro, in-silico, and in-vivo TE methods. First, I will engineer and characterize a clinical-grade ECM for high-pressure conditions and test patient-specific immuno- and hemocompatibility profile (in-vitro). Next, using computational modeling, I will design and develop a bioresorbable stent and implement an analytical valve design to develop the transcatheter prosthesis (in-silico). Finally, I will evaluate valve performance and remodeling in a preclinical large animal model (in-vivo). This highly multidisciplinary approach will lead to a valve prosthesis that lasts for life, as guided in-situ tissue remodeling will enable their long-term performance. The clinical impact will be enormous as, particularly for young patients, the TAVI4Life will significantly enhance their life expectancy and quality of life.

Status

SIGNED

Call topic

ERC-2019-STG

Update Date

27-04-2024
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Horizon 2020
H2020-EU.1. EXCELLENT SCIENCE
H2020-EU.1.1. EXCELLENT SCIENCE - European Research Council (ERC)
ERC-2019
ERC-2019-STG