Building on the accomplishments of the prior Phase I and Phase II NIH SBIR grants in which Infoscitex was the lead institution and MIT was the subcontractor, in this Phase II competitive renewal grant application we propose to develop a commercial quality catheter guidance system that will allow clinicians to treat ventricular tachycardia (VT) with radio frequency (RF) ablation. This system features an innovative single equivalent moving dipole (SEMD) inverse algorithm that reduces the total time required to locate the site of arrhythmia, precisely position an RF ablation catheter, and only requires that the patient be maintained in the arrhythmia for a few beats. During the first two years the team at Infoscitex will design and construct the commercial quality catheter guidance system while Professor Cohen at MIT will conduct animal studies using the prototype catheter guidance system developed during Phase II in order to refine the algorithms and procedures for using this system and to test the efficacy of the system in animal models of VT. During year 3 of this project, Dr. Cohen at MIT will test the commercial quality system in animal models of VT and the engineering team at Infoscitex will implement any modifications dictated by the animal testing. In addition, during the Phase II competitive renewal, we will take the steps needed to prepare for the successful commercialization of this technology either by spinning out a startup company or through licensure of the technology to an established company.
Ischemic heart disease is perhaps the most common pathophysiologic substrate for the development of ventricular tachycardia (VT). VT also occurs in a wide variety of different types of structural heart disease including non-ischemic dilated cardiomyopathy, hypertrophic cardiomyopathy, valvular disease, congenital heart disease, and primary electrophysiological abnormalities such as Wolff-Parkinson-White Syndrome [3]. However, it is estimated that 80% of sudden cardiac deaths attributed to arrhythmias occur in patients with a prior myocardial infarction (MI). The electrical properties of infarcted tissue can cause formation of a reentrant circuit and precipitation of a lethal VT. These regions can also become points of abnormal initiation of impulse activity. Transient myocardial ischemia, perhaps caused by coronary spasm or unstable platelet thrombi, can lead to death via the same mechanisms. This research is aimed at the development of a commercial quality catheter guidance system that will facilitate clinicians in treating VT with radio frequency (RF) ablation. This system features an innovative single equivalent moving dipole (SEMD) inverse algorithm that reduces the total time required to locate the site of arrhythmia, precisely position an RF ablation catheter, and only requires that the patient be maintained in the arrhythmia for a few beats. This clinical system will ultimately permit RF ablation to become an effective and efficient tool for treating a wide variety of VT, reducing mortality and morbidity from this prevalent clinical problem.
