DEVELOPMENT AND CLINICAL TEST OF QT VARIABILITY MONITOR

Robin Medical, Inc., Baltimore MD

Investigators

Linked publications & trials

Abstract

Dilated cardiomyopathy is a common syndrome with a high mortality rate, affecting about 4 million patients in the US. About half of these deaths are sudden, presumably due to lethal tachyarrhythmias, and growing evidence suggests that these arrhythmia are associated with altered ventricular repolarization. We aim to develop our methodology of QT-interval variability analysis, which quantifies ventricular repolarization lability, into a line of devices for long term risk stratification of sudden cardiac death (SCD) and for short term prediction of ventricular arrhythmia. Following demonstration of technical and clinical feasibility during Phase I, we plan to develop and test the first commercial device, a stand alone ECG monitor with QT-variability analysis capabilities, for risk stratification of SCD in heart failure patients; to collect additional data, by data recording in cardiac care unit and in implantable cardioverter defibrillators (ICDs), shortly before arrhythmia occurrence; and finally to use this data as the basis for the development of automatic arrhythmia predictive scheme, which compares realtime estimated parameters to a normal reference model. The latter application has enormous clinical importance for improved patient monitoring (in CCUs) and for improved function of ICDs. PROPOSED COMMERCIAL APPLICATIONS: A device which can define high risk of arrhythmia is critical to better allocate resources for arrhythmia prevention. Its potential market is related to the 5 billion dollars global market of ECG management devices: patient monitors, ECG recorders, holter systems, pacemakers, ICDs. Robin Medical has already established a joint venture with a leading manufacturer of ICDs looking into the use of QT monitoring for "prediction and prevention strategies" for ICDs.