Cardiac radiofrequency ablation catheter with integrated OCT imaging

具有集成 OCT 成像功能的心脏射频消融导管

• 批准号: 9105411
• 负责人: ANDREW Martin ROLLINS
• 金额: $ 23.78万
• 依托单位: CASE WESTERN RESERVE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2015
• 资助国家: 美国
• 起止时间: 2015-07-15 至 2019-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9105411
• 关键词: Ablation; Address; Adult; American; Anatomy; Animal Model; Animals; Arrhythmia; Blood; Blood flow; Cardiac; Cardiac ablation; Catheters; Clinical; Clinical Trials; Development; Devices; Dose; Echocardiography; Electrodes; Family suidae; Feedback; Fluoroscopy; Goals; Health; Heart; Image; Imagery; Imaging Device; Investigation; Lesion; Location; Measurement; Monitor; Morbidity - disease rate; Optical Coherence Tomography; Oryctolagus cuniculus; Outcome; Patient Care; Patients; Perforation; Physicians; Positioning Attribute; Preparation; Procedures; Puncture procedure; Radiation; Radiofrequency Catheter Ablation; Radiofrequency Interstitial Ablation; Research; Resolution; Safety; Site; Source; Steam; Structure; Surface; Tachyarrhythmias; Technology; Temperature; Testing; Thrombosis; Time; Tissue imaging; Tissues; Translations; United States; Work; base; clinical practice; curative treatments; design; electric impedance; experience; image guided; improved; improved outcome; meetings; microscopic imaging; mortality; pressure; prevent; programs; prototype; radiofrequency; skills training; standard of care; treatment site

 DESCRIPTION (provided by applicant): The long-term goal of this research program is to develop catheter-based optical coherence tomography (OCT) imaging tools that will improve the care of patients suffering from cardiac arrhythmias. This project aims to improve radiofrequency ablation (RFA) therapy, which is the standard of care for many arrhythmias, by providing microscopic image guidance at the tip of the catheter. This may potentially improve outcomes and safety and reduce procedure times. The specific objective of this proposal is to design, prototype, and validate a cardiac RFA catheter integrated with forward-viewing OCT imaging at the catheter tip. Cardiac arrhythmias are a major source of morbidity and mortality in the United States and catheter-based RFA through percutaneous access has emerged as the standard of care for the potential curative treatment of many arrhythmias. The goal of catheter ablation is to target and eradicate the critical component of an abnormal reentrant circuit or abnormal ectopic site by creating thermal lesions, usually on the endocardial surface of heart, while minimizing or avoiding damage to healthy, normal heart tissue. Practice of cardiac RFA requires a high level of skill and training. Electrophysiologists currently do not have real-time guidance at the cathete tip to identify critical substrates and structures to target or to avoid, to visualize catheter-tisue contact, nor to monitor the placement of a lesion or complications. Thus, current implementation of RFA in clinical practice is associated with significant unmet technological needs. Additional catheter-tip technology may decrease procedural time (and therefore radiation dose), improve outcomes and improve patient and operator safety. Previous results indicate that OCT imaging can address these unmet needs and can be accomplished within the heart via percutaneous access. Real-time, sub-surface imaging of the tissue at the catheter tip may potentially improve RFA therapy in four specific ways: (1) confirming catheter contact and orientation with the heart wall, (2) visualizing and identifying substrates to guide location of treatment sites, (3) monitorig lesion formation to confirm energy delivery, and (4) preventing complications such as steam pops, perforations, or thrombosis by detecting early signs of overtreatment, thin walls, and blood at the catheter tip. The specific aims of this design-directed project are: Aim 1: Design, prototype, and verify an integrated cardiac RFA/OCT catheter. Aim 2: Validate the primary functions of the integrated RFA/OCT catheter in animal models. The deliverable outcome of this two-year design-directed project will be an integrated RFA/OCT catheter design that is verified and validated in animal models. If successful, the results will justify further development and translation of the technology into a clinical device through large animal and clinical trials.

 描述（通过应用程序提供）：该研究计划的长期目标是开发基于导管的光学相干断层扫描（OCT）成像工具，以改善患有心律不齐的患者的护理。该项目旨在通过在导管尖端提供微观图像指导，以改善许多心律不齐的护理标准，这是许多心律不齐的护理标准。这可能会改善结果和安全性并减少程序时间。该提案的具体目标是设计，原型和验证与导管尖端的前视角OCT成像集成的心脏RFA导管。心律不齐是美国发病率和死亡率的主要来源，并且通过经皮通道基于导管的RFA已成为许多心律不齐的治疗方法的护理标准。导管消融的目的是通过在心脏的心内表面产生热病变来靶向和消除异常的恢复回路或异常生态部位的关键成分，同时最大程度地减少或避免损害健康的正常心脏组织。心脏RFA的练习需要高水平的技能和培训。当前的电生理学家目前没有在角ove尖端进行实时指导，无法识别靶向或避免，可视化导管 - 提示接触的关键基板和结构，也不监测病变或并发症的位置。这是当前在临床实践中RFA的实施与大量未满足的技术需求有关。其他导管尖端技术可能会减少程序时间（因此可以降低辐射剂量），改善结果并改善患者和操作员的安全。先前的结果表明，OCT成像可以满足这些未满足的需求，并且可以通过经皮进入在心脏内完成。在导管尖端的组织的实时，地下表面成像可能有四种特定方式可以改善RFA治疗：（1）确认导管接触和与心脏壁的取向，（2）可视化和识别底物以指导底物以指导治疗位置的位置，（3）通过确认能量传递的迹象，以及（4）诸如蒸汽，或者在蒸汽中的复杂性，以及蒸汽的复杂性，（4）过度治疗，薄壁和导管尖端的血液。该设计指导项目的具体目的是：AIM 1：设计，原型并验证集成的心脏RFA/OCT导管。 AIM 2：验证动物模型中综合RFA/OCT导管的主要功能。这个为期两年的设计指导项目的可交付结果将是一个集成的RFA/OCT导管设计，在动物模型中得到了验证和验证。如果成功，结果将证明通过大型动物和临床试验将技术的进一步发展和转化为临床装置。

项目成果

Imaging of Atrioventricular Nodal Conduction Tissue in Porcine Hearts Using Optical Coherence Tomography.

使用光学相干断层扫描对猪心脏房室结传导组织进行成像。

• DOI: 10.19102/icrm.2019.100601
• 发表时间: 2019
• 期刊: The Journal of innovations in cardiac rhythm management
• 作者: Kilinc,OrhanU;Zhao,Xiaowei;Jenkins,MichaelW;Snyder,ChristopherS;Rollins,AndrewM
• 通讯作者: Rollins,AndrewM