Precision medicine at the heart of heart failure therapy

This project aims at introducing precision medicine for improvement of cardiac resynchronization therapy (CRT) for heart failure. Heart failure is the leading cause of death and morbidity in the western world. 30% of all patients with heart failure need treatment with CRT caused by conduction defects in the conduction system in the heart. The conduction defect generates an ineffective pump function of the heart chambers. The conduction defect can be treated with CRT by placing pacemaker leads in the left and right heart chamber and thereby restore a synchronous and effective pump function. More than 100000 patients receive such treatment every year in the US and Europe, however more patients need treatment. Despite the treatment being effective, more than 30-50% of all patients treated have no effect of the treatment but are still lifelong exposed to unwanted negative effects. The prognosis of this group of patients remains poor. We have developed methods, through own research and research at the Oslo University Hospital, to better target patients who will have benefits from the treatment, and to find the right way of implementing treatment. In this way we will be able to convert treatment effect from a low responder rate to almost 100% responder rate, avoiding implantations in patients with no benefit. This will allow effective treatment at lower cost, providing the right treatment to the right patient at the right time! We are developing a cardiac catheter that can be used in patients to perform the diagnosis of dyssynchronous heart failure to ensure optimal resynchronization therapy. The catheter needs to comply with regulatory standards and the physician's needs for performance and usability, to be put to work as a clinically viable tool. Clinical studies will be performed on how the system can be implemented. The project will promote the utilization of CRT, and the treatment effect will improve with the world-wide implementation of our system.

Cardiac resynchronization therapy (CRT) with a pacemaker, is an expensive (25000 EURO/ patient) yet cost-effective heart failure therapy that saves lives. However, only up to two-thirds of patients who meet guidelines for CRT have beneficial effects. 1-2 billion EURO is annually spent on ineffective therapy in Europe/USA. Then, only one-third of HF patients eligible receives treatment, leaving a high number of patients without treatment at high costs to society (20000 EURO/year), and much more could be saved with improved utilization of CRT. We have discovered and developed a proprietary biomarker measured in patients with the PaCRTool-system, that will help select patients for CRT. The PaCRTool-system connects to the patient through ECG and electrogram electrodes and to an in-body sensor within the prototyped PreSens-catheter. This project will 1) do the final research and developments of the PaCRTool-system. It will be developed in an iterative process including research engineering, design controls, risk management and human factors research. There are no current medical devices that enable Pacertools' measurements on the market. 2) We will do the final research steps on the proprietary PreSens-catheter including pre-clinical experimental testing to confirm the biomarker performance. 3) Then we will perform the early feasibility clinical study for regulatory (CE-mark) and reimbursement purposes. This study will be designed to confirm the published experimental/ clinical data demonstrating the Pacertool biomarker using a pre-market research system in patients. The regulatory route is a driver in this project, and we will work closely with regulatory consultants to ensure compliance with the General Performance and Safety Requirements for market approval. The project is built on strong IPR; we will continue to exploit IPR. Subcontractors will be appointed for their expertise and to minimize risk. We will have the PaCRTool-system ready for market in two years.