Project: PreAmplifier the Next Generation: MR-compatible and wireless

• General background_x000D_The objective of this project is to develop the next generation of a preamplifier for a new hybrid system for the electrophysiological (EP) and hemodynamic examination of the heart, which is MR-compatible and wireless. This will provide a new flexibility to carry out examinations of cardiovascular diseases with conventional angiography or alternatively with the expected imaging modality of the future, MRT._x000D_• Market drivers in cardiology_x000D_1. Prevalence of cardiovascular diseases_x000D_According to the WHO cardiovascular diseases are the number one cause of death and since the major causes are tobacco use, physical inactivity, and an unhealthy diet it is projected to reCO so. An estimated 17.5 million people died from cardiovascular disease in 2005, representing 30 % of all global deaths. In studies it could be shown that approximately 1/3 of all stroke cases are related to atrial fibrillation, which is the most frequent persistent heart arrhythmia. The cardiologic market is therefore an attractive market, particularly growing for atrial fibrillation. _x000D_2. Innovative technologies_x000D_In diagnosis imaging modalities like CT, MRT and ultrasound are getting more importance in the clinical workflows in the heart catheter lab. CT for instance provides excellent anatomical images of heart and coronary arteries and is meanwhile established as an exclusion criterion for certain diseases. With MRT new functional information can be provided like blood flow, myocardium wall motion, vitality assessment of muscle tissue with stress-MRT and assessment of plaque in blood vessels. This functional information can have great impact on therapeutic decisions resulting in a better medical care and saving unnecessary costs. A better assessment of arteriosclerotic plaque and measurement of the vitality of myocardium can influence the decision pro or cons the implantation of a stent in the blood supplying vessel tremendously. In therapy a trend towards minimal-invasive interventions instead of heart surgery can be observed aiming to minimize the risk for the patient and to shorten the hospitalization. These new methods treat the heart through a catheter with visual real-time control of the intervention. Implants like occluders for PFO, heart valves, stents, and also balloons are delivered through catheters. To benefit from all these innovative methods in diagnosis and in therapy with real-time control, the single devices grow gradually more and more together. Hybrid scanners for imaging with navigation and integrated systems, offering comprehensive clinical solutions to the physician, are the future in the heart catheter lab aiming to provide a time efficient medical care on the highest available level for patients, very often hospitalized as an emergency case in the cardiology. _x000D_• Hybrid system: synergetic combination of EP and hemodynamic _x000D_EP and hemodynamic are closely related concerning workflow and clinical parameters. Every EP examination is a minimal-invasive intervention and in compliance with the guidelines the systemic arterial blood pressure as critical hemodynamic parameters has to be monitored. The measurement of the cardiac output with a hemodynamic monitoring system can be used as a tool to control the therapy with ablation, aiming to improve the imperfect contraction of the heart chambers due to misguided electric potential propagation. Therefore bringing both applications together in one hybrid system provides an efficient tool for the physician and will be the answer to the development on the device market towards complete clinical solutions. _x000D_• MRT as a key modality for cardiovascular diseases_x000D_The interventional diagnosis and therapy for patients with cardiovascular diseases with MRT is still at the beginning. Some experts believe in a hybrid scanner, others believe in the future diagnostic value of the MRT, partly replacing angiography. Presently the advantages of MRT as an imaging modality with 3-dimensional free positioning, functional imaging, and most important no exposure to radiation and well-tolerated contrast agents without iodine are motivating many research projects to work on this topic. The technical feasibility of real-time control with MR with specifically marked catheters and optimized imaging sequences and for interventions with MR-compatible instruments could be shown in research projects under study conditions. The hybrid system for EP and hemodynamic monitoring, developed in this project, will be the first product on the market for a safe and reliable diagnosis and treatment of cardiovascular diseases in the MR environment. _x000D_• Consortium of project_x000D_Participants are seleon (D), CardioTek (NL) and Schwarzer (D) as research perfoming SME's and medical device producers. Scientific Ps are Prof. Hennig, Medical Physics Dep. of Diagnostic Radiology University Hospital Freiburg (D) for the MR-experiments and Prof. Timmer, Institute for Physics in Freiburg (D) for data analysis. _x000D__x000D_

Acronym	PANG (Reference Number: 5185)
Duration	01/11/2010 - 28/02/2014
Project Topic	The objective is to develop a MR-compatible and wireless preamplifier for an innovative hybrid system for the electrophysiological and hemodynamic examination of the heart aiming for the future set-up in the heart catheter lab with angiography, with MRT or with a hybrid scanner.
Project Results (after finalisation)	In the frame of this project an algorithm to reconstruct ECG recorded in an MRI environment could be developed.
Network	Eurostars
Call	Eurostars Cut-Off 3

Project partner

Number	Name	Role	Country
6	CardioTek B.V.	Partner	Netherlands
6	Institute for Phyiscs, University of Freiburg	Partner	Germany
6	Schwarzer GmbH	Partner	Germany
6	seleon GmbH	Coordinator	Germany
6	Universitätsklinikum für die Medizinische Fakultät der Albert-Ludwigs-Universität Freiburg	Partner	Germany
6	Universitätsklinikum für die Medizinische Fakultät der Albert-Ludwigs-Universität Freiburg	Partner	Germany