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.
