2024-092, 2023-222, 2020-103 INVENTORS
SHORT DESCRIPTION This technology introduces an innovative AI-driven system for precise detection and treatment of atrial fibrillation (AF) through advanced 3D mapping and bipolar ablation. BACKGROUND Atrial Fibrillation (AF) is an irregular rapid heart rhythm and the most common heart disorder, affecting more than 6.1 million people in the U.S. with healthcare costs exceeding $6 billion annually. Unfortunately, conventional therapies and treatments have limited efficacy. Current diagnostic and therapeutic approaches often suffer from limitations in spatial resolution and multi-surface mapping capabilities, which impedes accurate localization of critical slow conduction zones and arrhythmogenic drivers. The current standard for catheter ablation, pulmonary vein isolation (PVI), has a success rate of only ~29% for those with persistent AF. A paradigm shift targeting the fundamental molecular mechanisms of AF is needed to improve patient outcomes and reduce healthcare costs. ABSTRACT This innovative technology provides an integrated system combining advanced multi-electrode mapping hardware and specialized software algorithms to detect and treat AF drivers by targeting both electrical reentry patterns and regions of elevated oxidative stress. Multiple catheter designs enable simultaneous endocardial and epicardial high-density mapping, capturing detailed intracardiac signals with optimized electrode spacing, while the hardware supports bipolar transmural ablation. The software employs AI-based algorithms that analyze electrogram metrics—including cycle length, dominant frequency, organization and fractionation indexes, conduction velocity, voltage, and activation patterns—both before and after administration of a ROS scavenger like N-acetylcysteine. Three distinct algorithmic approaches work collaboratively to identify hotspots via calculating percentage changes, assessing individual parameter overlaps, and performing multivariate analyses to delineate regions of slow conduction or high oxidative injury. The system generates real-time 3D visualizations of AF drivers and guides ablation strategies, validated through rigorous testing in passive and active heart setups as well as in vivo animal models, thereby linking structural characteristics, such as myofiber crossings and fibro-fatty infiltrations, to the functional substrates responsible for sustaining AF. APPLICATIONS
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