Clinical Evaluation of an Ultrasound Based Imaging System for Guiding Cardiac Abl

指导心脏功能的超声成像系统的临床评价

• 批准号: 8535544
• 负责人: PATRICK D WOLF
• 金额: $ 75.23万
• 依托单位: DUKE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-09-30 至 2016-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8535544
• 关键词: Ablation; Academic Medical Centers; Acoustics; Anatomy; Animal Experiments; Animal Testing; Animals; Arrhythmia; Atrial Fibrillation; Atrial Flutter; Biosensing Techniques; Blood Vessels; Breast; Canis familiaris; Cardiac; Cardiac ablation; Catheters; Clinic; Clinical; Clinical Research; Clinical Trials; Coagulation Process; Collaborations; Computer software; Development; Devices; Dimensions; Echocardiography; Electrophysiology (science); Environment; Funding; Healthcare; Heart; Heart Atrium; Hour; Human; Image; Imagery; Imaging technology; In Vitro; Institutional Review Boards; Kidney; Laboratories; Laboratory Animals; Left; Left atrial structure; Lesion; Liver; Location; Maps; Measures; Methods; Modification; Morbidity - disease rate; Multimodal Imaging; Myocardial; Navigation System; Patients; Phase; Physicians; Physiologic pulse; Positioning Attribute; Procedures; Process; Property; Pulmonary veins; Puncture procedure; Qualifying; Radiation; Radiofrequency Interstitial Ablation; Research; Right atrial structure; Series; Services; System; Tachyarrhythmias; Techniques; Technology; Testing; Three-Dimensional Imaging; Time; Tissues; Ultrasonography; United States; Ventricular; Wolves; Work; base; computerized data processing; image guided therapy; image processing; imaging modality; meetings; migration; novel; performance tests; prevent; programs; prototype; public health relevance; research clinical testing; tool

DESCRIPTION (provided by applicant): We propose to clinically evaluate the ability of a novel intracardiac ARFI ultrasound imaging system combined with an electro-anatomic mapping system to guide radio-frequency ablations procedures for treating atrial fibrillation and atrial flutter. In parallel, and in collaboration with our industrial partner Siemens Ultrasound, we will migrate these technologies to a 3D ultrasonic imaging platform and develop two intracardiac probes optimized for combined 3D B-mode/ARFI imaging. Phantom, animal and, ultimately, human studies are proposed to evaluate the 3D scanner/probes and the related pulse sequences, beam forming methods and signal and image processing methods to be developed. If successful, the proposed methods will provide the electrophysiologist with real-time visualization of cardiac ablation lesions and with the ability guide the creation of these lesions. As such, the proposed studies could markedly reduce treatment times for atrial and ventricular cardiac ablation procedures, prevent complications from over ablation and reduce the rates of repeat procedures. PUBLIC HEALTH RELEVANCE: We propose to move from the laboratory to the clinic the technique we developed in Phase I for image guided ablation therapy. This system can show the physician regions of the heart which have already been treated. Currently physicians have no means to examine these regions. In Phase I we successfully built the system and demonstrated its efficacy. In phase II we plan a series of clinical tests to demonstrate its utility for treating atrial arrhythmias in patients.

描述（由申请人提供）：我们提议临床评价新型心内ARFI超声成像系统与电解剖标测系统结合指导射频消融术治疗房颤和房扑的能力。与此同时，我们将与我们的工业合作伙伴Siemens Ultrasound合作，将这些技术迁移到3D超声成像平台，并开发两种针对组合3D B模式/ARFI成像进行优化的心内探头。提出了体模、动物和最终人体研究，以评价3D扫描仪/探头和相关脉冲序列、波束形成方法以及待开发的信号和图像处理方法。 如果成功的话，所提出的方法将为电生理学家提供心脏消融病变的实时可视化，并能够指导这些病变的创建。因此，拟议的研究可以显著减少心房和心室心脏消融术的治疗时间，预防过度消融的并发症，并降低重复手术的发生率。 公共卫生相关性：我们建议将我们在I期开发的图像引导消融治疗技术从实验室转移到临床。该系统可以向医生显示已经治疗过的心脏区域。目前，医生没有办法检查这些区域。在第一阶段，我们成功地建立了系统，并证明了其有效性。在第二阶段，我们计划进行一系列的临床试验，以证明其在治疗患者房性心律失常的效用。