Case study 2 – Medical device for non-invasive cardiac assessment in patients with Tetralogy of Fallot
Tetralogy of Fallot (ToF) is a rare condition caused by a combination of four heart defects that are present at birth (congenital). This combination of lesions occurs in 1 of every 35,0000-30,000 live births, and accounts for 7-10% of all congenital cardiac malformations. These defects, which affect the structure of the heart, cause oxygen-poor blood to flow out of the heart and to the rest of the body. All babies who have ToF need corrective surgery. The gold standard method to assess the cardiac mechanical function during open chest surgeries can only be performed through Transesophageal Echocardiography (TE). However, this technique is invasive and strictly depends on the user experience in both video acquisition and analysis. Moreover, it is used to assess the Left Ventricle but falls short in measuring the mechanical function of the Right Ventricle.
Main goals
The OrphaDev4Kids Project will support the development of a non-invasive medical device (Videocardiograph – VCG) for the assessment of the mechanical function of the heart in real time during open-chest surgery in children with tetralogy of Fallot (ToF) through the elaboration of high temporal and spatial resolution parameters of ventricular function using video kinematic recordings. The proposed MD is being developed by an innovative tech SME, J.E.M. Tech.