Intraoperative Pulsed Field Ablation and Lesion Assessment System

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Over 6 million Americans suffer from atrial fibrillation (AF), which negatively impacts their quality of life and is associated with high morbidity and mortality. Pulsed Electric Field Ablation (PFA) has emerged as a promising; non-thermal, tissue-specific ablation modality for treatment of AF. During PFA, trains of ultrashort (µs duration) high voltage (~2KV) electric pulses are delivered to the myocardium via single or multi-electrode catheters resulting in lesion formation by induced electric fields (e-fields). Intraoperatively, efficacy of PFA is assessed by diminution of local electrograms (iEGMs), which is unreliable and can be confounded by myocardial stunning and edema formation. Currently, there are no methods to intraoperatively assess PFA procedures, assess and confirm durable lesion formation. An intraoperative PFA-LAS, which can assess procedure parameters, assess and confirm durable lesion formation, will enable effectively deliver contiguous durable transmural lesions; significantly improving the safety and efficacy of PFA procedures. During this Phase 1 SBIR Project, we propose to develop a novel intraoperative Cardiac PFA Lesion Assessment System (PFA-LAS) using “High Frequency Dielectric Sensing” (HFDS) technology developed in our lab. HFDS technology involves redesigning the ablation electrodes of the PFA catheter as “miniature antennae”; and intraoperatively measuring their High Frequency Reflection Impedance Electrical Properties (HFEPs) at MHz-GHz frequencies. This enables simultaneously assess dielectric properties of the volume of tissue undergoing ablation in contact with electrode, and deliver the high voltage PFA pulses with the same electrodes; hence intraoperatively assess procedure parameters and confirm durable lesion formation. The system fits in an interventional EP lab, with no changes to procedural workflow. We will design, prototype and test in bench and animals, a first generation PFA-LAS, and definitively demonstrate its feasibility to intraoperatively monitor procedure parameters, assess and confirm durable lesion formation.