New generation of catheters for treatment of atrial fibrillation

ABSTRACT Atrial fibrillation (AF) remains the most commonly occurring cardiac arrhythmia. It is associated with a lower quality of life and a higher rate of morbidity and mortality primarily due to poor hemodynamic performance and often stroke. One of the primary options to treat AF is cardiac ablation where the physician applies radiofrequency energy via percutaneous catheters to form a series of lesions that directly destroys or isolates abnormal sources of electrical activity. Specific to AF ablation, a series of lesions are created to encircle the pulmonary veins forming an electrical barrier that isolates the arrhythmogenic foci inside the vein from the rest of the heart. However, while attempting to form lesion sets, the physician inadvertently leaves viable gaps that can be extremely difficult to detect, especially when the tissue is electrically stunned but remains metabolically viable. When this happens, these gaps will heal over time and reconduct the abnormal electrical activity to the rest of the heart, causing high post-procedural recurrence rates. As such, there is a strong clinical need to identify these gaps. Unfortunately, to date there are limited means for real-time monitoring of tissue injury and gap detection during ablation procedures and there are no means of directly detecting permanently damaged cardiac tissue. Here we propose to commercialize a new generation of percutaneous catheters that can distinguish viable from ablated cardiac tissue by sensing, in real time, spectral changes in tissue autofluorescence profiles caused by thermal damage. During the Phase II we produced and tested in live animals two versions of catheters, one that acquires an optical signature from a single fiber at the point where catheter tip touches the tissue, and a more complex version capable of hyperspectral imaging. This Phase IIB proposal seeks NIH funding to help commercialize the first optically enabled therapeutic ablation catheters under the trade name OmniView™. The first major task of the proposal to do so will be to manufacture 270 catheters and 20 instruments to be used for V&V testing and the subsequent clinical trial. These catheters and the instruments will undergo extensive V&V safety testing based upon standards outlined in the proposal. GLP live animal testing will be conducted in the large-animal porcine model. Following successful V&V testing, we will prepare an Investigational Device Exemption document set for submission to the FDA in order to receive permission to begin the clinical trial. We have identified five hospital sites with highly regarded electrophysiologists who are eager to participate. We have also held initial meetings with the FDA to obtain feedback on clinical strategy and have identified a CRO for clinical trial oversight. We will then perform the clinical trial as the key step towards commercialization. In summary, there remains an unmet clinical need for a system that can distinguish, in real-time, healthy versus ablated myocardial tissue with high resolution in order to identify and ablate gaps between lesions. Our new generation of percutaneous catheters and instruments is capable of acquiring tissue autofluorescence profiles during the ablation procedure therefore assisting physicians in providing better care.