E!113841 Precision medicine for improved and personalized Cardiac Resynchronization Therapy (CRT)

This project aims to introduce precision medicine to improve cardiac resynchronization therapy (CRT) for heart failure. Electrical conduction disease in the heart muscle is a critical cause of heart failure through heart disease or as a result of artificial stimulation of the heart through an implantable pacemaker. Pacertool has developed a system that measures the effects of conduction disease in the heart muscle to determine the cause of heart failure. The PaCRTool-system identifies patients who will benefit from resynchronization therapy and guides the implantation of a resynchronization device for treatment optimization. Heart failure associated with conduction disease is among the leading causes of death worldwide, and treatment is underutilized. The system will benefit millions of heart failure patients worldwide.

Pacertool is developing a medical device system that supports the implantation of pacemakers in heart failure patients. We have developed products that enable a proprietary biomarker measurement of dyssynchronous heart failure. The system consists of a cardiac catheter with a sensor for detection of the biomarker Td, software for processing of signals and a signal amplifier for signal acquisition. The project has enabled Pacertool to perform required research and investigations into device development and that regulatory process. We are now in the phase of finalizing products with the aim of entering the market in 2023 with disruptive products for the treatment of dyssynchronous heart failure. The technology will ensure personalized effective and optimized heart failure treatment and target a worldwide growing population of more than 26 million patients from whom 10-20% may benefit from the cost-effective Pacertool technology.

Development of an accelerometer mounted on the tip of an introducer sheet, digitally connected to PaCRTool, with similar performance as gold standard pressure sensors (Work Package (WP) 2). OUH has a long track record in evaluation of accelerometer signals for cardiac surveillance. Teaming up with OUH allows us to develop and validate accelerometers signals in an optimal environment with best possible chances of success. - Improvement of the software performance to be able to integrate accelerometer signals and to apply specific algorithms/ filtering to detect signal events within the SW (WP3). This will be led by PTOOL. - Development of a signal amplifier that works in the environment of PaCRTool (WP4). The new amplifier will provide optimal signal quality for automatic detection algorithms. CATH has extensive knowledge and will identify all specific elements that should be included (HW and SW interfaces, SW application), and develop an amplifier in order to meet optimal requirements for signal acquisition and performance. - Test the integrated HW (accelerometer + amplifier) and SW system in the animal laboratory and validate acceleration parameters against gold standard pressure sensors (WP5). - Preparation of regulatory documents and filings to speed up the regulatory processes (WP1)