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: 10609534
• 负责人: Parag Karmarkar
• 金额: $ 105.56万
• 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 2025-03-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10609534
• 关键词: Ablation; Address; Adverse event; Affect; Animal Testing; Animals; Arrhythmia; Atrial Fibrillation; Benchmarking; 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; Maps; 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; Titrations; Update; Validation; Visual; Work; clinic ready; clinical efficacy; commercialization; 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.

心房颤动（AF）影响美国超过600万人，是发病率的重要原因 和死亡率。经皮导管射频消融（RFA）治疗AF是标准 护理AF的治疗。但是，由于不完整，当前程序的复发率约为50％ 由于RF能量沉积过多，消融并承受并发症的风险约4％。有紧急 未满足的临床需求以提高心脏RFA程序的安全性和效率。 满足这种临床需求；我们正在开发术中高频介电感应 病变评估系统（HFDS-LAS）。我们的解决方案涉及；设计RFA的消融电极 导管作为“微型雷达”，以监测与天线相邻的组织的电特性 电极。该系统包括； a）带有整体天线传感器消融的消融导管 电极，b）矢量网络分析仪，以10 MHz的频率范围测量组织归属特性 到4 GHz，C）RF滤波器硬件以滤波（KHz）和测量（MHz-GHz）频率和D） 直观图形用户界面显示过程参数，病变状态和警告 高速和准确性的不良事件。 在第1阶段SBIR项目期间，我们原型制作了符合9.5FR的首个心脏HFDS-LAS 带有天线传感器电极的RFA导管，带选择性滤波器硬件和原型指南 用户界面（GUI）。在板凳和动物（n = 5）测试中，我们明确证明了 术中监测心脏RFA程序以准确：确认和量化电子组织 电触点；表征组织；确认并评估病变形成/消融程度；并预测 微泡和蒸汽流-POPS滴定RF功率，以安全有效地递送心房病变。这 系统与所有EP Cathlab设备兼容，例如心脏地图系统等，没有任何更改 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-LA的设计， 包括8.5FR导管，带有全向天线传感器电极，高保真滤波器硬件和一个 GUI显示组织类型，病变形成和关键程序参数。系统将经历 在体外进行验证和性能测试，并在动物中进行验证测试，以量化系统 表现;并启用提交前提交和提交给FDA以进行IDE许可 安全性和有效的临床试验。