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: 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
• 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

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）： 项目摘要 具有功能性单心室 (FSV) 解剖结构的先天性心脏病患者最终需要进行 Fontan 手术才能长期生存。 Fontan 手术的目标是将全身静脉血重新引导至肺循环，而不通过中间的心室。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。尽管在过去十年中与 Fontan 手术相关的发病率和死亡率已大大改善，但仍有许多患者出现并发症并最终因我们尚不完全了解的原因而导致 Fontan 失败。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测量值。这 测量反映了位于肺动脉分支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，在导管插入术实验室中获得的 Fontan 压力测量值受到执行手术本身所涉及的因素的影响，并且常常是错误的。与具有双心室解剖和生理学的患者相比，Fontan 独特的生理学使得这些因素对压力测量产生更显着的影响。此外，侵入性导管实验室测量仅提供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，并最终改善与这一高危患者群体相关的发病率和死亡率。这笔资助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，用于测量单心室解剖结构患者的 Fontan 通路中的压力。这种设备的商业开发将代表着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研究设备豁免 (IDE) 研究，该研究是该设备获准在美国营销和销售之前所必需的。行业赞助商 Integrated Sensing Systems, Inc. (ISSYS) 将提供每个临床中心开展研究所需的研究设备和设备。 UM 研究人员将设计多中心 IDE 试验，作为 IDE 试验的申办研究者，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 试验和后续工作完成后，将最终申请人道主义器械豁免 (HDE)。 ISSYS 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生产的制造流程，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。