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

用于测量先天性心脏病患者心内压的新型微型植入物

基本信息

批准号：
8686556
负责人：
Martin Bocks
金额：
$ 100万
依托单位：
INTEGRATED SENSING SYSTEMS, INC. (ISSYS)
依托单位国家：
美国
项目类别：
财政年份：
2011
资助国家：
美国
起止时间：
2011-09-01 至 2017-05-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8686556
关键词：
Activities of Daily Living Anatomy Arteries Authorization documentation Blood Blood Circulation Blood Vessels Blood flow Blue Cross Cardiac Cardiac Catheterization Procedures Cardiovascular system Caring Catheterization Charge Chronic Clinical Trials Code Common Ventricle Communication Complex Computer software Contracts Country Data Databases Development Devices Elements Enrollment Ensure Environment Equipment Europe European European Union Failure Fontan Procedure Goals Grant Health Health Insurance Portability and Accountability Act Heart Home environment Hospitals Human Resources Implant Industry Institutional Review Boards International Internet Laboratories Lead Life Lung Maintenance Managed Care Marketing Measurement Measures Medical Care Team Medical Device Michigan Monitor Morbidity - disease rate Pathway interactions Patients Physicians Physiology Postoperative Period Procedures Process Production Pulmonary Artery Branch Pulmonary Circulation Pump Ramp Recruitment Activity Reporting Research Infrastructure Research Personnel Rest Route Safety Sales Scandinavia Schools Services Structure System Systems Integration Technology Time Training United States Universities Venous Ventricular Wireless Technology Work Workplace clinical research site commercialization compliance behavior congenital heart disorder cost data management design follow-up formycin triphosphate hemodynamics high risk implantation improved intracardiac pressure manufacturing process meetings mortality new technology novel operation patient population post-market pressure public health relevance sensor vigilance

项目摘要

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.

描述（由申请人提供）：功能性单脑室（FSV）解剖结构的项目摘要最终需要Fontan操作才能长期生存。 Fontan操作的目的是将系统性的静脉血重新释放到肺部循环，而不会穿过中间的心室腔室。结果，流向肺的血流几乎完全是一个被动的非脉冲过程。尽管在过去的十年中，与Fontan程序相关的发病率和死亡率已大大提高，但由于我们尚未完全理解的原因，仍然有许多患者患有并发症和最终的Fontan失败。 Fontan途径中的压力可以说是最紧密地预测受损循环的整体健康的单个测量。这测量反映了分支肺动脉和全身单脑室之间所有心脏和血管结构的一般状况。不幸的是，在导管实验室中获得的方丹压力测量值是可变的，而且通常错误地受到执行程序本身涉及的要素的影响。与双室解剖学和生理学患者相比，方丹的独特生理允许这些因素对压力测量的影响更大。此外，侵入性的CATH LAB测量仅提供了独特循环中发生的事情的快照，并且不能代表日常生活正常活动中发生的事情。在门诊环境中测量慢性串行方通路压力的能力将使人们更好地了解丰坦生理学，并最终会改善与这个高风险患者人群相关的发病率和死亡率。该赠款的研究人员一直在开发一种新型的微型无线植入压力传感器，以测量单脑室解剖患者Fontan途径的压力。这种设备的商业开发将代表为这一高风险患者人群提供护理的重大技术进步。在拟议的赠款中，密歇根大学（UM）的调查人员将领导努力进行调查设备豁免（IDE）研究，这是在该设备被批准用于美国营销和销售之前所需的。行业赞助商，Integrated Sensing Systems，Inc。（ISSYS）将提供每个临床站点进行研究所需的研究设备和设备。 UM的调查人员将设计多中心IDE 试验，担任IDE试验的赞助商研究者，在UM中注册患者，监督其他临床试验地点的患者入学，并与FDA和ISSYS合作提交审判和随访完成后，人道主义设备豁免（HDE）的最终申请。 ISSYS将负责执行所有HDE活动，包括市场警惕，将最终确定生产这些植入物的制造过程，维护FDA要求的医疗设备质量质量基础设施，并负责所有商业化活动。