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

• 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
• 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

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.

心房纤颤（AF）在美国影响超过600万人，并且是发病的重要原因 and mortality.经皮导管射频消融（RFA）治疗房颤是标准的 然而，目前的手术由于不完全的治疗，复发率约为50%。 由于过度的射频能量沉积，消融并具有约4%的并发症风险。目前迫切 改善心脏RFA手术安全性和有效性的未满足临床需求。 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技术， 病变评估系统（HFDS-LAS）。我们的解决方案包括：设计射频消融电极 导管作为"微型雷达"来监测天线附近组织的电特性- 电极上该系统包括：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，用于在10 MHz的频率范围内测量组织介电特性 c）射频滤波器硬件，以过滤消融（KHz）和测量（MHz-GHz）频率，以及d） 直观的图形用户界面，可显示手术参数、病变形成状态和 快速准确地处理不良事件。 在第1阶段SBIR项目中，我们制作了首个心脏HFDS-LAS原型，包括9.5Fr 射频消融导管，配有天线传感器电极、频带选择性滤波器硬件和原型指南 用户界面（GUI）。在实验室和动物（n = 5）测试中，我们明确证明了 术中监测心脏RFA手术，以准确确认和量化电极组织 电接触;表征组织;确认和评估损伤形成/消融程度;并预测 微泡和蒸汽爆裂滴定射频功率，以安全有效地输送心房损伤。的 系统与所有电生理导管室设备兼容，例如心脏标测系统等，没有变化， 心脏RFA手术工作流程。 在项目的第二阶段，我们将进行优化和测试，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。该系统将经历 体外验证和性能测试以及动物确认测试，以明确量化系统 性能;并能够向FDA提交预申请和申请，以获得IDE批准， 安全性和有效性临床试验。