SIMCorIn-Silico testing and validation of Cardiovascular Implantable devices
Funding programme: Horizon 2020 (N 101017578)
Coordinator: CHARITE - UNIVERSITAETSMEDIZIN BERLIN (CHARITE)
Duration: 3 years (Jan 2021 - Dec 2024)
The SIMCor project aims to develop an in-silico platform and simulation tools for the development, validation and regulatory approval of cardiovascular devices, providing tangible value to patients and clinicians, device manufacturers, clinical researchers, medical authorities and regulatory bodies.
It will focus on two clinically and economically relevant cardiovascular procedures and devices, transcatheter aortic valve implantation (TAVI) and pulmonary artery pressure sensors (PAPS), and will extrapolate best practices for in-silico trials that will be translated into Standard Operating Procedures (SOPs) for all cardiovascular device manufacturing and clinical communities.
In order to achieve this, SIMCor will define a methodology for the generation of virtual cohorts for in-silico tests to lower the burden of preclinical tests in animals, as well as of clinical I-III stage human trials. Device-specific models will also be developed to predict device performance in terms of safety, efficacy and usability endpoints, utilising computer simulations. The consortium will then assess and quantify the impact of the virtual cohorts and computer simulations in the “real world”. The main goal is to increase treatment efficacy and patient safety while boosting innovation in the field of cardiology.
ECRIN's role in SIMCor
ECRIN is responsible for developing a conceptual framework to model the effects of computer simulation for medical device testing on clinical trial planning and to assess the clinical impact of in-silico trials. This will allow the estimation of benefits offered by in-silico technologies along several outcome dimensions such as a reduction in the duration and sample size of clinical trials, increased clinical efficacy and patient safety.