Intraoperative cardiac pulsed field ablation and lesion assessment system - over 6 million americans suffer from atrial fibrillation (AF), which negatively impacts their quality of life and is…

The National Heart, Lung, and Blood Institute awarded Sigt LLC $848,381 on September 1, 2026, to develop a clinical-grade intraoperative cardiac pulsed field ablation and lesion assessment system under the Cardiovascular Diseases Research program (CFDA 93.837), a Phase II Small Business Innovation Research project.

Sigt LLC will develop a pulsed field ablation lesion assessment system (PFA-LAS) using proprietary high frequency dielectric sensing (HFDS) technology to enable intraoperative assessment of ablation procedure parameters and confirmation of durable lesion formation during treatment of atrial fibrillation. The system redesigns ablation catheter electrodes as miniature antennae to measure high-frequency reflection impedance electrical properties at megahertz-to-gigahertz frequencies, allowing simultaneous measurement of tissue dielectric properties and delivery of high-voltage pulsed electric field ablation pulses through the same electrodes. This capability addresses a current clinical gap: existing intraoperative assessment methods that rely on local electrogram diminution are unreliable and subject to confounding from myocardial stunning and edema, leading to collateral injuries including hemolysis-induced renal failure, non-contractile atria, and repeat procedures. The PFA-LAS will enable physicians to titrate pulsed field ablation applications to deliver precision ablations, improving safety and efficacy.

Performance will occur in Columbia, Maryland. The award period runs through July 31, 2028.

Intraoperative cardiac pulsed field ablation and lesion assessment system - 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). Currently, there are no methods to intraoperatively assess PFA procedures, assess and confirm durable lesion formation. 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. This leads to collateral injuries such as hemolysis induced renal failure, non-contractile atria, and repeat procedures. An intraoperative PFA-LAS, which can assess procedure parameters, assess and confirm durable lesion formation and enable physician's titrate PFA pulse applications to deliver precision ablations, will significantly improving the safety and efficacy of PFA procedures. During this phase II sbir project, we will develop a clinical grade cardiac PFA and 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, test and optimize in bench and animals, a clinical grade PFA-LAS, and quantify its safety and efficacy to deliver durable PVI and non-PVI substrates in preclinical studies.