This document was developed to provide two standard operating procedures (SOP) on flow field assessment of transcatheter aortic valve implants (TAVI) by means of numerical simulation applying fluid structure interaction (FSI) and particle image velocimetry measurements. The SOPs are designed for SIMCor partners as well as for the scientific community.

The SOP-D4.5.1 is about building a computational model and performing simulations in the field of FSI for TAVI. Where applicable, existing standards and guidance are referenced within this document. Additionally, specific exemplary applications of the general procedure and recommendations are given, using the TAVI use case, which represents a minimally invasive implantation of biological valve prostheses into the aortic root via catheterization.

The SOP-D4.5.2 provides recommendations and standardised procedures and workflows for performing flow field measurement in TAVI by means of Particle Image Velocimetry (PIV). The document describes working steps and gives general important information in preparation and performing PIV measurements in TAVI. Explanations and recommendations are provided throughout the protocol to extend the understanding of different components and working steps of a PIV system and the corresponding measurement method.

Standards, guidelines, and recommendations for flow field assessment in TAVI were applied. Confronting the current workflow with the evolving practice as the project continues may lead to updates, thus subsequent iterations of the SOP are foreseen.

SIMCor (In-Silico testing and validation of Cardiovascular IMplantable devices) has received funding from the European Union's Horizon 2020 research and innovation programme under grant agreement No 101017578.