Personal Electrocardiographic Expert System

DESCRIPTION (provided by applicant): The overall goal of the project is to design and develop an easy-to-use miniaturized Personal Electrocardiographic Expert (PELEX) system for real-time, on-site registration, analysis, and wireless transmission of electrocardiographic (EGG) data using structured pattern recognition approach for tracking changes in individual ECGs. The system will be designed both for clinical and non-clinical settings, including home-based monitoring, ambulatory follow-up, First Aid in emergency and mass casualty situations. For all these settings, a system that provides a real-time, on-the-scene ECG examination, analysis, and wireless transmission is urgently needed. Analysis of ECG changes in existing devices is limited, so that only a few parameters are compared to normal values or to the previous ECG recording. The completed system (Phase I and II) will include: 1) complete, in-depth analysis of ECG changes over time, 2) detection of subtle abnormalities that are hard to identify by visual inspection, 3) individually tailored analysis, 4) fast and efficient wireless communication between individual patient recorders, central computers, and health-care providers, 5) optimized collection, storage, and retrieval of serial data, and 6) comprehensive presentation of analyzed data to the health-care provider and appropriate feedback to the patient. During Phase I, we have developed an Alpha prototype system and demonstrated its feasibility in the laboratory and clinical settings. The system has been enthusiastically received by cardiologists and spurred a strong interest from the device industry leaders. PELEX is the first all-in-one miniature (2x1x0.3 inch) wireless system that allows virtually any type of ECG testing, including gold-standard 12-lead ECG recording, stress-testing, 3/12 lead telemetry, ambulatory (Holter), event, and loop monitoring. PELEX has automatic bidirectional communication with central computer server, which performs complete analysis of ECG waveforms and an automatic, remote adjustment (individual tailoring) of monitored parameters. In Phase II, we will refine and further improve the system to develop a Beta-prototype and conduct a larger-scale clinical trial both in a hospital and ambulatory setting to validate its performance against the best currently available systems and to receive feedback from medical professionals and patients. Safety and regulatory testing will be completed, and a 51O K application will be submitted to the FDA.