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

• 批准号: 8895381
• 负责人: Martin Bocks
• 金额: $ 98.68万
• 依托单位: INTEGRATED SENSING SYSTEMS, INC. (ISSYS)
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-09-01 至 2016-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8895381
• 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

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）：项目总结功能性单心室（FSV）解剖结构的先天性心脏病患者最终需要Fontan手术才能获得长期生存。Fontan手术的目的是将体静脉血重新引导至肺循环，而不通过介入的心室腔。因此，流向肺部的血液几乎完全是被动的、非脉动的过程。尽管Fontan手术相关的发病率和死亡率在过去十年中有了显著改善，但仍有许多患者发生并发症，最终Fontan失败，原因我们尚不完全清楚。Fontan通路中的压力可以说是最接近地预测缓和循环的整体健康的单一测量。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状况。不幸的是，在导管插入实验室中获得的Fontan压力测量值不稳定，并且经常错误地受到执行程序本身所涉及的元件的影响。与双心室解剖结构和生理结构的患者相比，Fontan的独特生理结构允许这些因素对压力测量值产生更显著的影响。此外，有创导管室测量仅提供了独特循环内发生的情况的快照，并不代表日常生活正常活动期间发生的情况。在门诊环境中测量慢性、连续Fontan通路压力的能力将使我们更好地了解Fontan生理学，并最终改善与这一高风险患者人群相关的发病率和死亡率。该基金的研究人员一直在开发一种新型的微型无线植入式压力传感器，用于测量单心室解剖结构患者的Fontan通路中的压力。这种器械的商业开发将代表为这一高风险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）的研究人员将领导开展研究器械豁免（IDE）研究，这是该器械在美国获准上市和销售之前所需的。行业赞助商Integrated Sensing Systems，Inc.（ISBN）将提供各临床试验机构开展研究所需的试验用器械和设备。UM的研究者将设计多中心IDE 试验，担任IDE试验的申办者研究者，在UM招募患者，监督其他临床试验中心的患者招募，并与FDA和ISBN合作提交 一旦试验和随访完成，人道主义器械豁免（HDE）的最终申请。ISBN将负责执行所有HDE后活动，包括上市后警戒，将最终确定这些植入物的生产工艺，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。