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CORDIS

In Silico testing and validation of Cardiovascular Implantable devices

Deliverables

In-silico trial impact assessment framework

Document describing the conceptual framework for the insilico trial impact assessment

Project handbook

Reference document indicating standards for project management internal communication meetings and reporting

Project presentation

Document presenting project rationale mission goals and expected outcomes in common language to be used as base for the launch of initial press releases and production of preliminary communication materials

Validated constitutive models of the vessel wall

Report on constitutive model validation

Quality assurance guidelines

Reference document with procedures and best practices to guarantee quality of reporting

Constitutive vessel model

Simplified vessel model describing the homogeneous behavior of the vessel once in contact with the device

Self-assessment plan

Reference document indicating specific goals and key performance indicators for selfassessment of WP activities

Report on 3D finite element simulation

Report on the results of 3D simulations for a subset of patients.

First version of the simulation models

A document that describes the selection of the first version of simulation models for virtual cohort generation and the installation of models within the computing framework for the parallel simulation of multiple patient datasets

Reduced order model

Description of the reduced order model implemented in a prototype

Sensitivity and uncertainty quantification toolbox

A report that demonstrates the proofofprinciple of the application of uncertainty quantification and sensitivity analysis to both use cases

System requirements

Document describing the defined technical requirements for the adaptation and extension of the cloudbased infrastructure its integration structure and workflow elements

Guidelines for documentation

Providing guidelines for documentation of reports for hemodynamic studies of TAVI in medical device submissions

Data management plan

Document describing how data will be acquired processed and stored in compliance with privacy and security obligations

Communication and dissemination strategy plan

Document describing the overall project strategy for communication and dissemination including analysis of primary and secondary audiences envisaged strategies and preliminarily produced materials

Definition of model output

A document with definition of the outputs of interests their correlations and their joint probability density functions for each of the two insilico clinical trials in WP9

Conceptual framework report

Report describing the conceptual framework that illustrates all effect channels that the use of virtual cohorts and computer simulations may have

Enhanced constitutive vessel model

Report on development and parameterization of enhanced constitutive vessel models of the pulmonary artery and aortic sinus.

First version of the definition of the input space

A document that elaborates on how the available data templates are converted to a first definition of the input space ie based on expert opinion

Kick-off meeting report

Report on topics issues and outcomes of the project kickoff meeting

Regulatory feedback report (1)

Report incorporating feedback from the first and second round up with regulatory authorities on SOPs, virtual cohort generation, device effect simulation and translation into the clinical setting.

Uncertainty quantification and re-definition of input space

A document describing how the input space can be redefined based on the results of a sensitivity analysis and it can reduce the output uncertainty for both use cases

SOPs for data acquisition for in-silico models

Providing standards and workflow for preclinical and clinical data acquisition.

Fast device deployment model

Modelling of the fast device deployment process implemented in a prototype.

Specification of data-processing requirements

A protocol specifying imaging modality settings (resolutions, quality measures, formats) for TAVI and PAPS.

Specification and quantification of synthetic boundary conditions

An elaboration of specification for synthetic boundary condition generation (standards, quality measures, formats).

SOPs for data processing for in-silico models

Describing procedures and workflows for the processing of preclinical (in vitro, in vivo) and clinical data (imaging, sensor data) for generating virtual cohorts.

Specification and quantification of subject-specific data-based boundary conditions

An elaboration of specification describing formats and resolution of clinical imaging and sensor data used for simulations with subject-specific boundary conditions.

SOPs for in-silico analysis of TAVI

Providing standard protocols for performing CFD and FSI simulation as well as PIV measurements of TAVI in medical device submissions

SOPs for virtual cohorts generation and validation

Describing procedures for optimal virtual cohort generation and validation.

IGA model

IGA based model for 3D device deployment simulation

Uncertainty quantification for input data

Tools, parameters and methods for quantification of clinical data used as boundary conditions for simulations and for validation.

SOPs for validation of in-silico models

Providing standard protocols for multi-level validation of in-silico models

Validated virtual cohorts for in-silico trials

Accurate validated virtual cohorts will be delivered for both use cases.

Publications

Surrogate model based sensitivity analysis of a one dimensional arterial pulse wave propagation model with correlated input

Author(s): Pjotr Hilhorst
Published in: NO JOURNAL TITLE, Issue 5, 2022
Publisher: Zenodo
DOI: 10.5281/zenodo.7225277

A statistical shape model of the porcine and human pulmonary artery for evaluation of medical devices

Author(s): Jan Brüning
Published in: 2023
Publisher: ESB2023
DOI: 10.5281/zenodo.8164649

SIMCor. Deliverable 7.2 - Definition of model templates (TUE, M9)

Author(s): Huberts, Wouter
Published in: 2021
Publisher: OpenAIRE
DOI: 10.5281/zenodo.6146528

SIMCor. Deliverable 7.4 - Sensitivity and uncertainty quantification toolbox (TUE, M15)

Author(s): Huberts, Wouter
Published in: 2022
Publisher: N/A
DOI: 10.5281/zenodo.7036217

SIMCor. Deliverable 1.3: Project handbook (LYN, M4)

Author(s): Anna Rizzo
Published in: NA, Issue NA, 2021, Page(s) NA
Publisher: NA
DOI: 10.5281/zenodo.4750993

SIMCor. Deliverable 6.1 - Data processing requirements (CHA, M4)

Author(s): Brüning, Jan
Published in: 2021
Publisher: OpenAIRE
DOI: 10.5281/zenodo.5094742

SIMCor. Deliverable 4.2 - Standard operating procedures for data processing for in-silico models (CHA, M12)

Author(s): Bruning, Jan; Krüger, Nina; Goubergrits, Leonid; Lesage, Raphaëlle; Huberts, Wouter; Schievano, Silvia
Published in: 2021
Publisher: OpenAIRE
DOI: 10.5281/zenodo.6150519

From Engineering Metrics to Clinical Endpoints

Author(s): Andreas Arndt
Published in: 2023
Publisher: ESB2023
DOI: 10.5281/zenodo.8164674

Virtual cohort generation and validation

Author(s): Wouter Huberts
Published in: 2023
Publisher: ESB2023
DOI: 10.5281/zenodo.8164594

SIMCor. Deliverable 3.2 - Data management plan (LYN, M6)

Author(s): Rizzo, Anna
Published in: 2021
Publisher: OpenAIRE
DOI: 10.5281/zenodo.5095494

SIMCor. Leaflet

Author(s): Rizzo, Anna; Servidio, Stefania
Published in: Issue 2, 2022
Publisher: N/A
DOI: 10.5281/zenodo.6151181

SIMCor. Deliverable 7.8 - Validated virtual cohorts for in-silico trials (TUE, CHA)

Author(s): Huberts, Wouter; Verstraeten, Sabine; Brüning, Jan
Published in: Issue 3, 2023
Publisher: Zenodo
DOI: 10.5281/zenodo.10670423

SIMCor. Deliverable 2.1 - Project presentation (LYN, M1)

Author(s): Rizzo, Anna
Published in: 2021
Publisher: OpenAIRE
DOI: 10.5281/zenodo.4644534

SIMCor. Deliverable 2.2 - Communication and dissemination strategy plan (LYN, M2)

Author(s): Rizzo, Anna
Published in: 2021
Publisher: OpenAIRE
DOI: 10.5281/zenodo.4664231

SIMCor. Deliverable 1.2 - Kick-off meeting report (LYN, M2)

Author(s): De Maldè, Mirko
Published in: 2021
Publisher: OpenAIRE
DOI: 10.5281/zenodo.4644568

SIMCor. Deiverable 6.3 - Uncertainty quantification for input data (CHA, M21)

Author(s): Goubergrits, Leonid; Kruger, Nina; Bruning, Jan
Published in: 2022
Publisher: N/A
DOI: 10.5281/zenodo.7105663

SIMCor. Deliverable 1.3 - Project handbook (LYN, M4)

Author(s): Anna Rizzo
Published in: 2021
Publisher: OpenAIRE
DOI: 10.5281/zenodo.4750992

SIMCor. Deliverable 7.1 - Definition of model output (TUE, M6)

Author(s): Huberts, Wouter
Published in: 2021
Publisher: OpenAIRE
DOI: 10.5281/zenodo.6074807

SIMCor. Deliverable 4.1 - SOPs for data acquisition for in-silico models (UCL, M18)

Author(s): Schievano, Silvia; Capelli, Claudio; Bruning, Jan; Lesage, Raphaelle; Ohmann, Christian; Panagiotopoulou, Maria; Montgomery Liljeroth, Ebba; Staument, Bernard
Published in: 2022
Publisher: N/A
DOI: 10.5281/zenodo.7041346

Mapping the use of computer modelling and simulation in clinics

Author(s): Raphaëlle; Michiel; Silvia; Ine; Claudio; Giulia; Martina; Roberta; Goran
Published in: NA, Issue NA, 2022, Page(s) NA
Publisher: VPH Institute
DOI: 10.5281/zenodo.7974392

SIMCor. Deliverable 7.3 - First version of the definition of the input space (TUE, M12)

Author(s): Huberts, Wouter
Published in: 2021
Publisher: OpenAIRE
DOI: 10.5281/zenodo.6150326

Patient-based clinical trials

Author(s): Pablo E. Verde
Published in: 2023
Publisher: ESB2023
DOI: 10.5281/zenodo.8164661

SIMCor. Deliverable 1.5 – Quality assurance guidelines (LYN, M8)

Author(s): De Maldè, Mirko
Published in: 2021
Publisher: OpenAIRE
DOI: 10.5281/zenodo.5095412

SIMCor. Deliverable 7.5 - Uncertainty quantification and re-definition of input space (TUE, M18)

Author(s): Huberts, Wouter; Stiehm, Michael; Borowsky, Finja; Oldeburg, Jan
Published in: 2022
Publisher: N/A
DOI: 10.5281/zenodo.7041286

Virtual cohort generation of aortic valve stenosis geometries

Author(s): Sabine Verstraeten; Frans van de Vosse; Wouter Huberts
Published in: 2023
Publisher: ESB2023
DOI: 10.5281/zenodo.8164617

SIMCor. Deliverable 4.4 - Guidelines for documentation (IIB, M12)

Author(s): Stiehm, Michael; Brüning, Jan; Lesage, Raphaëlle; Czypionka, Thomas; Oldenburg, Jan; Huberts, Wouter; Rolf-Pissarczyk, Malte; Luther; Torsten; Staumont, Bernard; Geris, Liesbet
Published in: 2021
Publisher: OpenAIRE
DOI: 10.5281/zenodo.6150904

SIMCor. Deliverable 1.4 - Self-assessment plan (LYN, M6)

Author(s): De Maldè, Mirko
Published in: 2021
Publisher: OpenAIRE
DOI: 10.5281/zenodo.5095487

SIMCor. Deliverable 10.1 - In-silico trial impact assessment framework (ECRIN, M12)

Author(s): Aydin, Burç; Ohmann, Christian
Published in: 2021
Publisher: OpenAIRE
DOI: 10.5281/zenodo.6353627

A fast in silico model for preoperative risk assessment of paravalvular leakage

Author(s): Michelle Spanjaards, Finja Borowski, Laura Supp, René Ubachs, Valentina Lavezzo & Olaf van der Sluis
Published in: Biomechanics and Modeling in Mechanobiology, 2024, ISSN 1617-7940
Publisher: Springer
DOI: 10.1007/s10237-024-01816-8

Feasibility Assessment of Using CDISC Data Standards for in vivo and in silico Medical Device Trials

Author(s): Burç Aydin, Eanna Kiely, Christian Ohmann
Published in: Journal of the Society of Clinical Data Management, Issue Volume 3, Issue 3 2023, Fall 2023, 2023, ISSN 2694-1473
Publisher: Society of clinical data management
DOI: 10.47912/jscdm.230

CT‑based comparison of porcine, ovine, and human pulmonary arterial morphometry

Author(s): Leonid Goubergrits, Marie Schafstedde, Nikola Cesarovic, Angelika Szengel, Boris Schmitt, Moritz Wiegand, Jan Romberg 4, Andreas Arndt 4, Titus Kuehne 1,2 & Jan Brüning 1,2*
Published in: Scientific reports, 2023, ISSN 2045-2322
Publisher: Nature Publishing Group
DOI: 10.1038/s41598-023-47532-8

Analysis on the effects of hypo-attenuated leaflet thickening on the hemodynamics of transcatheter aortic valve prostheses by means of particle image velocimetry

Author(s): Oldenburg, Jan, Borowski, Finja, Kaule, Sebastian, Schmitz, Klaus-Peter, Öner, Alper and Stiehm, Michael.
Published in: tm - Technisches Messen, 2023, ISSN 2196-7113
Publisher: Oldenbourg Wissenschaftsverlag
DOI: 10.1515/teme-2022-0116

Validation of a Fluid Structure Interaction Model for TAVR using Particle Image Velocimetry

Author(s): Finja Borowski, Robert Ott, Jan Oldenburg, Sebastian Kaule, Alper Öner, Klaus-Peter Schmitz, Michael Stiehm
Published in: Current Directions in Biomedical Engineering, Issue vol. 8, no. 2, 2022, Page(s) 512-515, ISSN 2364-5504
Publisher: De Gruyter
DOI: 10.1515/cdbme-2022-1131

Computation of flow through TAVI device by means of physics informed neural networks

Author(s): Oldenburg, Jan, Borowski, Finja, Schmitz, Klaus-Peter and Stiehm, Michael.
Published in: Current Directions in Biomedical Engineering, Issue vol. 8, no. 2, 2022, Page(s) 741-744, ISSN 2364-5504
Publisher: De Gruyter
DOI: 10.1515/cdbme-2022-1189

Mapping the use of computational modelling and simulation in clinics: A survey

Author(s): Lesage, R., Van Oudheusden, M., Schievano, S., Van Hoyweghen, I., Geris, L., Capelli, C.
Published in: Frontiers in Medical Technology, 2023, ISSN 2673-3129
Publisher: Frontiers Media S.A.
DOI: 10.3389/fmedt.2023.1125524

Geometry aware physics informed neural network surrogate for solving Navier–Stokes equation (GAPINN)

Author(s): Jan Oldenburg; Finja Borowski; Alper Öner; Klaus-Peter Schmitz; Michael Stiehm
Published in: Advanced Modeling and Simulation in Engineering Sciences, Issue 9, 2022, ISSN 2213-7467
Publisher: Springer Open
DOI: 10.1186/s40323-022-00221-z

Efficient sensitivity analysis for biomechanical models with correlated inputs

Author(s): Pjotr L. J. Hilhorst, Sjeng Quicken, Frans N. van de Vosse, Wouter Huberts
Published in: International Journal for Numerical Methods in Biomedical Engineering, 2023, ISSN 2040-7947
Publisher: Wiley Online LIbrary
DOI: 10.1002/cnm.3797

Echocardiogram-based ventricular isogeometric cardiac analysis using multi-patch fitted NURBS

Author(s): Robin Willems, Lex Verberne, Olaf van der Sluis, Clemens V. Verhoosel
Published in: Computer Methods in Applied Mechanics and Engineering, Issue 425, 2024, Page(s) 116958, ISSN 0045-7825
Publisher: Elsevier BV
DOI: 10.1016/j.cma.2024.116958

In-silico enhanced animal study of pulmonary artery pressure sensors: assessing hemodynamics using computational fluid dynamics

Author(s): Jan Brüning, Pavlo Yevtushenko, Adriano Schlief, Tobias Jochum, Livia van Gijzen, Sonja Meine, Jan Romberg, Titus Kuehne, Andreas Arndt, Leonid Goubergrits
Published in: Frontiers in Cardiovascular Medicine, 2023, ISSN 2297-055X
Publisher: Frontiers
DOI: 10.3389/fcvm.2023.1193209

Critical time-step size analysis and mass scaling by ghost-penalty forimmersogeometric explicit dynamics

Author(s): Stein K.F. Stoter, Sai C. Divi, E. Harald van Brummelen, Mats G. Larson, Frits de Prenter, Clemens V. Verhoosel
Published in: Computer Methods in Applied Mechanics and Engineering, Issue Volume 412, 1 July 2023, 2023, Page(s) 116074, ISSN 0045-7825
Publisher: Elsevier BV
DOI: 10.1016/j.cma.2023.116074

CFD-based synthetic data generation for machine learning based pressure drop assessment in aortic stenosis

Author(s): Matei, T. I., Popescu, A. B., Nita, C. I., Ciusdel, C. F., & Itu, L. M.
Published in: Studies in Informatics and Control, Issue 32(4), 2023, Page(s) 49-58, ISSN 1220-1766
Publisher: National Institute for R & D in Informatics

Analysis of thrombosis risk of commissural misaligned transcatheter aortic valve prostheses using particle image velocimetry

Author(s): Finja Borowski, Sebastian Kaule, Jan Oldenburg, Klaus-Peter Schmitz, Alper Öner and Michael Stiehm
Published in: tm - Technisches Messen, 2023, ISSN 2196-7113
Publisher: Oldenbourg Wissenschaftsverlag
DOI: 10.1515/teme-2022-0100

Scientific and regulatory evaluation of mechanistic in silico drug and disease models in drug development: Building model credibility

Author(s): Flora T. Musuamba,Ine Skottheim Rusten,Raphaëlle Lesage,Giulia Russo,Roberta Bursi,Luca Emili,Gaby Wangorsch,Efthymios Manolis,Kristin E. Karlsson,Alexander Kulesza,Eulalie Courcelles,Jean-Pierre Boissel,Cécile F. Rousseau,Emmanuelle M. Voisin,Rossana Alessandrello,Nuno Curado,Enrico Dall’ara,Blanca Rodriguez,Francesco Pappalardo, Liesbet Geris.
Published in: CPT: Pharmacometrics & Systems Pharmacology, Issue 10 (8), 2021, Page(s) 804-825, ISSN 2163-8306
Publisher: Nature Publishing Group
DOI: 10.1002/psp4.12669

Cascaded neural network-based CT image processing for aortic root analysis

Author(s): Nina Krüger; Alexander Meyer; Lennart Tautz; Markus Hüllebrand; Isaac Wamala; Marius Pullig; Markus Kofler; Jörg Kempfert; Simon Sündermann; Volkmar Falk; Anja Hennemuth
Published in: International Journal of Computer Assisted Radiology and Surgery, 17 (3), Issue 17, 2022, Page(s) 507–519, ISSN 1861-6410
Publisher: Springer Verlag
DOI: 10.1007/s11548-021-02554-3

Pre-operative risk assessment of paravalvular leakage using a computational TAVI deployment model

Author(s): Spanjaards, M., Ubachs, R., Lavezzo, V., Van der Sluis, O
Published in: 28th Annual Conference of the European Society of Biomechanics (ESB2023), 2023
Publisher: European Society of Biomechanics

Potential of using shell elements methods in FSI simulations of pulmonary arteries

Author(s): Moradi, H., van de Vosse, F., Huberts, W
Published in: 28th Annual Conference of the European Society of Biomechanics (ESB2023), 2023
Publisher: European Society of Biomechanics

Inter-species differences in pulmonary artery morphometry and hemodynamics

Author(s): Brüning, J., Krüger, N., Yevtushenko, P., Goubergrits, L.
Published in: 28th Annual Conference of the European Society of Biomechanics (ESB2023), 2023
Publisher: European Society of Biomechanics

Measurement of Steady Flow through a Transcatheter Aortic Valve Replacement by means of Particle Image Velocimetry

Author(s): Jan Oldenburg, Finja Borowski, Sebastian Kaule, Alper Öner, Klaus-Peter Schmitz and Michael Stiehm
Published in: 2022
Publisher: German Society for Laser Anemometry (GALA) Annual Conference

Identification of the most influential factors on pulmonary artery hemodynamics using variance-based sensitivity analysis

Author(s): Moradi, Hamed; Van de Vosse, Frans; Huberts, Wouter
Published in: VPH2022 Abstract Book, Issue 5, 2022
Publisher: VPH Institute
DOI: 10.5281/zenodo.7488716

Validation of a Synthetic Cohort of Aortic Stenosis Patients

Author(s): Brüning, Jan; Yevtushenko, Pavlo; Goubergrits, Leonid
Published in: VPH2022 Abstract Book, Issue 1, 2022
Publisher: VPH Institute
DOI: 10.5281/zenodo.7488850

Deep Learning Based Detection of Collateral Circulation in Coronary Angiographies

Author(s): Cosmin-Andrei Hatfaludi; Daniel Bunescu; Costin Florian Ciuşdel; Alex Serban; Karl Böse; Marc Oppel; Stephanie Schröder; Christopher Seehase; Harald F. Langer; Jeanette Erdmann; Henry Nording; Lucian Mihai Itu
Published in: Crossref, Issue 7, 2022
Publisher: Institute of Electrical and Electronic Engineers
DOI: 10.1109/cbms58004.2023.00337

Non-parametric statistical shape modelling for in silico trials of TAVI

Author(s): Verstraeten, Sabine; Suasso de Lima de Prado, Damián; Hoeijmakers, Martijn; Van de Vosse, Frans; Huberts, Wouter
Published in: VPH2022 Abstract Book, Issue 2, 2022
Publisher: VPH Institute
DOI: 10.5281/zenodo.7488786

Virtual cohort generation for in silico trials of transcatheter aortic valve implantation

Author(s): Verstraeten, S., Hoeijmakers, M., van de Vosse, F., Huberts, W.
Published in: 28th Annual Conference of the European Society of Biomechanics (ESB2023), 2023
Publisher: European Society of Biomechanics

Sensitivity analysis of an one-dimensional pulse wave propagation model with correlated input

Author(s): Hilhorst, Pjotr; Quicken, Sjeng; Van de Vosse, Frans; Huberts, Wouter
Published in: VPH2022 Abstract Book, Issue 4, 2022
Publisher: VPH Institute
DOI: 10.5281/zenodo.7488829

Assessment of Thrombogenic Potential of Prosthetic Heart Valves based on Particle Image Velocimetry Measurements

Author(s): Finja Borowski, Jan Oldenburg, Sebastian Kaule, Klaus-Peter Schmitz, Alper Öner, Michael Stiehm1
Published in: 2022
Publisher: German Society for Laser Anemometry (GALA) Annual Meeting

Computer modelling and simulation in clinics: mapping usage and opinions for advancing in silico medicine

Author(s): Raphaelle Lesage; Michiel Van Oudheusden; Martina Contin; Silvia Schievano; Liesbet Geris; Claudio Capelli
Published in: VPH2022 Abstract Book, Issue 3, 2022
Publisher: VPH Institute
DOI: 10.5281/zenodo.7437507

Generation of synthetic aortic valve stenosis geometries for in silico trials

Author(s): Sabine Verstraeten, Martijn Hoeijmakers, Pim Tonino, Jan Brüning, Claudio Capelli, Frans van de Vosse, Wouter Huberts
Published in: Numerical Methods in Biomedical Engineering, 2023, ISSN 2040-7939
Publisher: John Wiley & Sons Ltd.
DOI: 10.1002/cnm.3778

Scan-based immersed isogeometric flow analysis

Author(s): Verhoosel, Clemens V.; van Brummelen, E. Harald; Divi, Sai C.; de Prenter, Frits
Published in: Frontiers in Computational Fluid-Structure Interaction and Flow Simulation: Research from Lead Investigators under 40 - 2022, edited by Tayfun Tezduyar, 2022, Springer Nature Switzerland AG, Issue 1, 2022, ISSN 2331-8422
Publisher: Forntiers
DOI: 10.48550/arxiv.2208.14994

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