Novel Micro-Implant to Measure Intracardiac Pressure in Congenital Heart Patients

描述(由申请人提供)：项目摘要具有功能性单心室(FSV)解剖的先天性心脏病患者最终需要Fontan手术以获得长期生存。Fontan手术的目标是在不通过中间脑室的情况下将全身静脉血液重新路由到肺循环。因此，流向肺部的血液几乎完全是一个被动的、非脉动的过程。尽管与Fontan手术相关的发病率和死亡率在过去十年中有了很大的改善，但仍有许多患者出现并发症，最终Fontan失败，原因我们尚不完全清楚。可以说，Fontan通路中的压力是最能准确预测姑息循环整体健康状况的单一指标。这 测量反映了位于分支肺动脉和全身单心室之间的所有心脏和血管结构的一般情况。不幸的是，在插管实验室获得的Fontan压力测量结果受操作过程中涉及的因素的影响多变，而且常常是错误的。Fontan独特的生理功能使这些因素对压力测量的影响比具有双心室解剖和生理功能的患者更大。此外，侵入性导管实验室测量仅提供了独特循环内发生的情况的快照，并不代表日常生活活动期间发生的情况。在动态环境中测量慢性连续Fontan通路压力的能力将有助于更好地了解Fontan生理学，并最终将改善与这一高危患者群体相关的发病率和死亡率。这笔赠款的研究人员一直在开发一种新型微型无线植入式压力传感器，用于测量单脑室解剖患者Fontan通路中的压力。这种设备的商业开发将代表着在为这一高危患者群体提供护理方面的重大技术进步。在拟议的拨款中，密歇根大学(UM)的研究人员将牵头开展调查设备豁免(IDE)研究，这是该设备获准在美国营销和销售之前所需的。行业赞助商集成传感系统公司(ISsys)将为每个临床站点提供开展这项研究所需的研究设备和设备。密歇根大学的研究人员将设计多中心集成开发环境 试验，作为IDE试验的赞助商调查员，在UM招募患者，监督其他临床试验地点的患者招募，并与FDA和ISsys合作提交 一旦试验和后续行动完成，最终申请人道主义设备豁免(HDE)。ISsys将负责执行HDE后的所有活动，包括后市场警觉，将最终确定生产这些植入物的制造工艺，维护FDA要求的医疗器械质量基础设施，并负责所有商业化活动。

DESCRIPTION (provided by applicant): PROJECT SUMMARY Congenital heart disease patients with functional single ventricle (FSV) anatomy ultimately require a Fontan operation for long term survival. The goal of the Fontan operation is to re-route systemic venous blood to the pulmonary circulation without passing through an intervening ventricular chamber. As a result, blood flow to the lungs is almost entirely a passive, non-pulsatile process. Although morbidity and mortality associated with the Fontan procedure has improved considerably over the last decade, there are still many patients who develop complications and eventual Fontan failure for reasons we do not yet entirely understand. The pressure in the Fontan pathway is arguably the single measurement that most closely predicts the overall health of the palliated circulation. This measurement reflects the general condition of all the cardiac and vascular structures that lie between the branch pulmonary arteries and the systemic single ventricle. Unfortunately, Fontan pressure measurements obtained in the catheterization laboratory are variably, and often erroneously, influenced by elements involved in performing the procedure itself. The unique physiology of the Fontan allows these factors to have a more significant influence on the pressure measurements compared to patients with biventricular anatomy and physiology. Furthermore, the invasive cath lab measurement provides only a snapshot of what is occurring within the unique circulation and does not represent what is taking place during normal activities of daily living. The ability to measure chronic, serial Fontan pathway pressures in an ambulatory setting will result in a better understanding of the Fontan physiology and should ultimately improve morbidity and mortality associated with this high risk patient population. Investigators on this grant have been developing a novel miniature wireless implantable pressure sensor to measure the pressure in the Fontan pathway of patients with single ventricle anatomy. Commercial development of such a device would represent a significant technological advancement in providing care to this high risk patient population. In the proposed grant, investigators at the University of Michigan (UM) will lead the effort to carry out the Investigational Device Exemption (IDE) study that is required before the device can be approved for marketing and sales in the United States. The industry sponsor, Integrated Sensing Systems, Inc. (ISSYS) will provide the investigational device and equipment required for each clinical site to carry-out the study. Investigators at UM will design the multi-center IDE trial, serve as the Sponsor Investigator for the IDE trial, enroll patients at the UM, oversee enrollment of patients at the other clinical trial sites, and work with FDA and ISSYS to submit the final application for Humanitarian Device Exemption (HDE) once the trial and follow-up is completed. ISSYS will be responsible for performing all the post HDE activities, including Post Market Vigilance, will finalize the manufacturing process for production of these implants, maintain the FDA-required medical-device quality infrastructure, and be in charge of all commercialization activities.