High frequency dielectric sensing cardiac radio frequency ablation monitoring and lesion assessment system - atrial fibrillation (AF) affects over 6 million individuals in the USA and is a significant…

High frequency dielectric sensing cardiac radio frequency ablation monitoring and lesion assessment system - atrial fibrillation (AF) affects over 6 million individuals in the USA and is a significant cause of morbidity and mortality. Percutaneous catheter radio frequency ablation (RFA) treatment of AF is the standard of care for treatment of AF. However, current procedures have a ~50% recurrence rate, due to incomplete ablations and carry a ~4% risk of complications, due to excessive RF energy deposition. There is an urgent unmet clinical need to improve the safety and efficacy of cardiac RFA procedures. To address this clinical need; we are developing an intraoperative high frequency dielectric sensing lesion assessment system (HFDS-LAS). Our solution involves; designing the ablation electrode of an RFA catheter as a "miniature radar" to monitor the electrical properties of the tissue adjacent to the antenna- electrode. The system comprises; a) steerable ablation catheter with an integrated antenna-sensor ablation electrode, B) vector network analyzer to measure tissue dielectric properties in a frequency range of 10 MHZ to 4 GHZ, C) RF filter hardware to filter ablation (KHZ) and measurement (MHZ-GHZ) frequencies and D) intuitive graphic user interface which displays procedure parameters, state of lesion formation and warns of adverse events at high speed and accuracy. During phase 1 sbir project, we prototyped a first-of-its-kind cardiac HFDS-LAS comprising a 9.5FR RFA catheter with an antenna-sensor electrode, band selective filter hardware and a prototype guidance user interface (GUI). In bench and animal (N=5) testing, we definitively demonstrated feasibility of intraoperatively monitoring cardiac RFA procedures to accurately: confirm and quantify electrode-tissue electrical contact; characterize tissue; confirm and assess lesion formation/extent of ablation; and predict micro-bubbles and steam-pops to titrate RF power to safely and efficaciously deliver atrial lesions. The system is compatible with all EP cathlab equipment e.g. cardiac mapping systems, etc., with no changes to cardiac RFA procedural workflow. During phase 2 of the project, we will optimize and test to finalize design of a clinical grade HFDS-LAS, comprising 8.5FR catheter with omnidirectional antenna-sensor electrode, high fidelity filter hardware and a GUI displaying tissue type, lesion formation and critical procedure parameters. The system will undergo verification and performance testing in vitro and validation testing in animals to definitively quantify system performance; and enable submit a pre submission and a submission to the FDA for IDE clearance towards a safety and efficacy clinical trial.