ECG R-Wave and Current of Injury 1.3 2007/12/17 06:29:23 US/Central 2007/12/17 15:13:17.816 US/Central Sally Anzelc salsters_542@yahoo.com Sally Anzelc salsters_542@yahoo.com Current of Injury R-Wave Module 2: Method/Protocol This protocol is being written after studying the document on Research Proposal Format found on the World Wide Web. All sections of the protocol are addressed below. Determine which field of science you are most interested in: This protocol focuses on active fixation Medtronic leads for atrial/ventricular applications. Proposed research question: Is it possible and/or desirable to eliminate the current of injury (COI) phenomenon during cardiac active fixation lead implantation? The protocol will either manage COI or eliminate it through filtering of this “interference” signal. Brief descriptive title of proposed research: ECG R-Wave and Current of Injury Reason for research: Currently, active fixation lead implantation causes acute endocardial tissue injury that manifests as an increased R-wave on an ECG. The implant physician may think that an adequate R-wave has been captured (≥ 5mV). However, when the COI subsides, the R-wave may not be adequate. The only solution to this is another surgery for the patient. The physician must re-open the device “pocket” and re-position the lead. Background information on your topic: Background information has been provided in the introduction of this paper. The papers by Saxonhouse et al, Redfearn et al, and Laske et al provide the background information. List of references relevant to your topic: Please see the references section at the end of this paper. Any hypothesis(ses) relevant to your research that you are specifically investigating: Instead of trying to eliminate the current of injury, as it can mask the true R-wave value, is it a useful tool for predicting adequate lead fixation and pacing thresholds? The current literature describes COI as an important tool for determining acceptable lead fixation and thresholds. Resources available to you already: Professor Holte, Jim Glover (Medtronic Field Engineer), U of M Biomedical Library, lab space and equipment at Medtronic Other resources you think you will need in order to proceed: My time on evenings or weekends, as I work full-time. Also, I may need an updated statistical package for data analysis. Potential costs for additional resources: Unknown at this time. I have access to a Pruka 3 and Medtronic 2290 analyzer, but any other equipment would be a cost. Proposed experiment: The entire methodology of Redfearn et al will be carried out in order to see if their results are reproducible. In addition, the lead data post-implant will be saved to disk. I will research various filtering techniques that may be able to separate the current of injury from the true R-wave post-fixation. Timetable: I am allowing one month for obtaining patient consent and internal review board approval. Collecting lead data, statistical data analysis, and writing the research report should take approximately three months. Any other concerns for this research: The research must be approved by the internal review boards at the University of Minnesota and at Medtronic, Inc. Also, all patients must provide written consent. After compiling and analyzing data, reach logical conclusions and write a research report: This is out of the scope of the current project, as the goal is to write this protocol.