NOCTURNAL PRODUCT DEVELOPMENT, LLC — Department of Health and Human Services STTR Phase II: NHLBI

Description

DESCRIPTION provided by applicant 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 andamp mortality primarily due to poor hemodynamics and often stroke One of the main options to treat atrial fibrillation is to ablate abnormal sources of electrical activity using percutaneous radiofrequency RF catheters RF lesions isolate the spread of abnormal electrical activity from various sites in the heart including the pulmonary veins As a result a cornerstone of therapy in AF ablation procedures is to electrically isolate the pulmonary veins PVs with RF lesions essentially creating an electrical barrier between the arrhythmogenic foci inside the PVs and the rest of the heart Often the cardiologist over ablates or under ablates leaving gaps which can still transmit the abnormal electrical activity to the rest of the heart To date there are limited means for real time monitoring of tissue injury during RF ablation procedures and there are no means of directly visualizing ablated cardiac tissue to distinguish it from viable conducting tissue Here we propose to create a new generation of imaging catheters to distinguish normal cardiac tissue from ablated cardiac tissue in real time They operate based on spectral changes in tissue autofluorescence caused by thermal damage Specifically in Phase II we will expand the design of our current st generation catheter that relied on acquiring emission from a single spectral band to include acquisition from multiple emission bands within an autofluorescence range of nm and to use post acquisition analysis to reveal thermal damage to layers of endocardial collagen and underlying atrial muscle The UV multispectral catheter will be then used to examine and visualize percutaneous RF ablation lesions in live large animals such as pigs We also test on freshly excised donated human atrial tissue The catheter will undergo extensive documentation verification and validation in order to be approved for use in a human study Manufacturing process instructions will be developed and reviewed by the manufacturing partners who will construct package and sterilize the various catheter components We will work with our clinical partners to develop a human study protocol and will develop informed consent documentation instructions for use and other documentation necessary for ethics review and FDA approval At the end of Phase II we aim to have a fully functional statistically tested Fr multispectral imaging catheter approved and ready for first in man studies Our ultimate long term goal is to develop a new generation of ablation catheters enabling real time visualization of ablated cardiac tissue This technology will pave the way for easier faster safer more cost effective more reliable and minimally invasive AF ablation procedures by allowing cardiologists to see in real time if lesions are complete or if there are gaps that need to be filled in in the case of a patient who has a recurrence post ablation the catheter will be used to quickly and efficiently identify where the gap is if one exists PUBLIC HEALTH RELEVANCE Atrial fibrillation is a major health concern and a primary cause of stroke and thromboembolism Percutaneous cardiac catheter ablation is currently used to treat atrial fibrillation in order to eliminate a lifelong multidrug regimen but its main limitaion is high recurrence rate due to poor intra procedural ablation monitoring and the inability to visualize lesions directly We propose to develop and commercialize a new generation of imaging catheters that enable direct real time visualization of radiofrequency ablation lesions to achieve safer faster cheaper and more reliable atrial fibrillation ablation therapy