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

描述(申请人提供)：我们建议临床评估一种新的心内ARFI超声成像系统与电解剖标测系统相结合的能力，以指导射频消融治疗心房颤动和心房扑动。同时，我们将与我们的工业合作伙伴西门子超声波公司合作，将这些技术移植到3D超声成像平台，并开发两个针对3D B型/ARFI联合成像进行优化的心内探头。建议对3D扫描仪/探头和相关的脉冲序列、波束形成方法以及待开发的信号和图像处理方法进行体模、动物以及最终的人体研究。 如果成功，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房室心脏消融手术的治疗时间，防止过度消融的并发症，并降低重复手术的比率。 公共卫生相关性：我们建议将我们在第一阶段开发的图像引导消融治疗技术从实验室转移到临床。这个系统可以显示已经治疗过的心脏的医生区域。目前，医生没有办法检查这些区域。在第一阶段，我们成功地构建了该系统，并展示了其有效性。在第二阶段，我们计划进行一系列临床试验，以证明其在治疗患者房性心律失常方面的有效性。

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.