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

基本信息

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
项目类别：
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

项目摘要

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（由申请人提供）：该研究项目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，以改善心律失常患者的护理。该项目旨在改善射频消融（ RFA）疗法是许多心律失常的护理标准，通过在导管尖端提供显微图像引导，这可能会改善结果和安全性并减少手术时间。该提案旨在设计、原型设计并验证在导管尖端集成前视 OCT 成像的心脏 RFA 导管。心律失常是美国发病率和死亡率的主要来源，通过经皮通路进行的基于导管的 RFA 已经出现。作为许多心律失常的潜在治愈性治疗的护理标准导管消融的目标是通过产生热损伤来瞄准和根除异常折返回路或异常异位部位的关键部分，通常在心脏的心内膜表面，同时最大限度地减少或避免对健康、正常心脏组织的损害。电生理学家目前没有在导管尖端进行实时指导来识别关键基质。因此，当前 RFA 在临床实践中的实施与显着的未满足的技术需求相关。手术时间（以及辐射）先前的结果表明，OCT 成像可以解决这些未满足的需求，并且可以通过导管尖端组织的实时、表面下成像来实现。潜在地通过四种具体方式改善 RFA 治疗：(1) 确认导管与心壁的接触和方向，(2) 可视化和识别基质以指导治疗部位的位置，(3) 监测病变形成以确认能量输送，以及 (4 ）防止出现蒸汽爆裂等并发症，该设计导向项目的具体目标是：目标 1：设计、原型并验证集成心脏 RFA/OCT 导管。 2：在动物模型中验证集成 RFA/OCT 导管的主要功能这个为期两年的设计导向项目的可交付成果将是在动物模型中验证和验证的集成 RFA/OCT 导管设计。如果成功，结果将证明通过大型动物和临床试验进一步开发该技术并将其转化为临床设备是合理的。