High Frequency Dielectric Sensing Cardiac Radio Frequency Ablation Monitoring and Lesion Assessment System

高频介电感应心脏射频消融监测和病变评估系统

基本信息

批准号：
10483317
负责人：
Parag Karmarkar
金额：
$ 59.83万
依托单位：
SIGT, LLC
依托单位国家：
美国
项目类别：
财政年份：
2019
资助国家：
美国
起止时间：
2019-05-01 至 2024-03-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10483317
关键词：
Ablation Address Adverse event Affect Animal Testing Animals Arrhythmia Atrial Fibrillation Cardiac Cardiac ablation Catheters Clinical Clinical Research Cryosurgery Data Deposition Electrodes Equipment Frequencies Future Health Care Costs Heart Atrium In Vitro Individual Injury Intraoperative Monitoring Intuition Lesion Measurement Measures Mechanics Microbubbles Monitor Morbidity - disease rate Noise Outcome Patients Performance Phase Physiologic pulse Preclinical Testing Procedures Quality of life Radar Radiofrequency Interstitial Ablation Recurrence Risk Safety Small Business Innovation Research Grant Speed Steam System Technology Testing Time Tissues Update Validation Visual Work base clinical efficacy cost effective design dielectric property efficacy clinical trial electrical property graphical user interface improved in vitro testing in vivo mortality novel performance tests pre-clinical prevent processing speed prototype real time monitoring sensor sensor technology standard of care success vector

项目摘要

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.

心房颤动 (AF) 在美国影响着超过 600 万人，是发病的一个重要原因经皮导管射频消融 (RFA) 治疗 AF 是标准治疗方法。然而，由于治疗不彻底，目前的治疗复发率约为 50%。由于过多的射频能量沉积，消融并带来约 4% 的并发症风险。提高心脏 RFA 手术安全性和有效性的临床需求尚未得到满足。为了满足这一临床需求；我们正在开发一种术中高频介电传感我们的解决方案包括设计 RFA 消融电极。导管作为“微型雷达”来监测与天线相邻的组织的电特性—— 该系统包括：a) 具有集成天线传感器消融的可操纵消融导管。电极，b) 矢量网络分析仪，用于测量 10 MHz 频率范围内的组织介电特性至 4 GHz，c) 用于过滤消融 (KHz) 和测量 (MHz-GHz) 频率的射频滤波器硬件，以及 d) 直观的图形用户界面，显示程序参数、病变形成状态和警告快速、准确地处理不良事件。在第一阶段 SBIR 项目中，我们制作了首个心脏 HFDS-LAS 原型，其中包含 9.5Fr 带有天线传感器电极、频带选择滤波器硬件和原型指南的 RFA 导管用户界面 (GUI)。在实验室和动物 (n=5) 测试中，我们明确证明了其可行性。术中监测心脏 RFA 程序以准确：确认和量化电极组织电接触；确定和评估病变形成/消融程度；微气泡和蒸汽爆破滴定射频功率，以安全有效地输送心房病变。系统与所有 EP 导管实验室设备兼容，例如心脏测绘系统等，无需更改心脏 RFA 程序工作流程。在项目的第二阶段，我们将优化和测试以最终确定临床级 HFDS-LAS 的设计，包括带有全向天线传感器电极的 8.5Fr 导管、高保真滤波器硬件和 GUI 显示组织类型、病变形成和关键手术参数。体外验证和性能测试以及动物验证测试，以明确量化系统性能；并允许向 FDA 提交预提交和提交以获得 IDE 许可安全性和有效性的临床试验。