PeriPath: A Single Incision Delivery Tool for Epicardial Pacing and Defibrillation: Phase 2

PeriPath：用于心外膜起搏和除颤的单切口输送工具：第 2 阶段

• 批准号: 10547070
• 负责人: CHARLES I BERUL
• 金额: $ 91.41万
• 依托单位: PERICOR, LLC
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-01 至 2024-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10547070
• 关键词: Adhesions; Adult; Animal Model; Businesses; Caliber; Cardiac; Cardiac Surgery procedures; Chest; Child; Childhood; Chronic; Clinical Research; Clinical Trials; Complex; Coronary sinus structure; Defect; Defibrillators; Devices; Dilator; Electric Countershock; Endoscopes; Family suidae; Feasibility Studies; Goals; Growth; Health system; Heart; Human; Implant; Implantable Defibrillators; Industry; Infant; Institutional Review Boards; Intensive Care; Intervention; Investigation; Lead; Left ventricular structure; Life; Location; Measures; Medical Device; Methods; Monitor; Morbidity - disease rate; Needles; Newborn Infant; Obstruction; Operative Surgical Procedures; Outcome; Pacemakers; Pain; Patients; Pediatric Hospitals; Performance; Pericardial body location; Phase; Procedures; Puncture procedure; Recovery; Regulation; Research; Research Design; Research Personnel; Respiratory Diaphragm; Route; Safety; Side; Small Business Innovation Research Grant; Sternotomy; Surface; Surgeon; Surgical incisions; Surgical sutures; System; Techniques; Test Result; Testing; Thoracic Surgical Procedures; Thoracotomy; Time; Tissues; Trocars; United States; Venous; Visualization; Work; blind; cardiac device; cardiac implant; cardiac resynchronization therapy; clinical practice; commercialization; congenital anomaly; congenital heart disorder; experience; first-in-human; healing; heart rhythm; heart visualization; implantation; improved; infant animal; infection risk; millimeter; minimally invasive; multidisciplinary; novel; pain reduction; pediatric patients; porcine model; pre-clinical; prototype; sample fixation; success; tool; usability; venous sinus; verification and validation

Project Summary Each year, nearly 7,200 infants in the United States are born with a complex congenital heart disease that requires surgical intervention within the first year of life. For infants and young children with heart rhythm abnormalities, interventional treatment can be especially difficult, as the size of their vasculature and/or congenital anomalies typically preclude a transvenous approach for implanting a cardiac device such as a pacemaker or defibrillator. As a result, infants must undergo a sternotomy or thoracotomy to access the epicardial surface of the heart. We have developed a novel minimally-invasive pericardial access tool to deliver pacing and defibrillation leads to the epicardial surface of the heart under direct visualization from an endoscope. Utilizing this tool, we hypothesize that we can safely and effectively deliver pacing and defibrillation therapy through a single small port. By using a percutaneous approach, this should reduce pain and risk of infection, decrease procedure times, and minimize operative complications from an open surgical approach. In addition, direct visualization of the procedure makes it safer than blind pericardial punctures. Our team has utilized an immature porcine model implantation of cardiac devices, and demonstrated the percutaneous approach was as safe and effective as an open surgical technique. The specific goal of this Phase II SBIR project is to demonstrate superior pericardial access and epicardial pacing compared to a commercial trocar using a preclinical animal model with infant growth rate, followed by first in human (FIH) clinical trials to accelerate regulatory approval and commercialization of the PeriPath tool. In this work, we will complete the following 3 specific aims: Aim 1: Demonstrate superior performance and usability to a commercial trocar as measured by device performance and handling in tissue plates. We will conduct a pilot verification build of the PeriPath device in compliance with FDA regulation. Devices will be subjected to usability, verification, and validation testing and results compared to an EndoPath trocar using a two-one-sided test. Success is defined as PeriPath achieving superior performance and pericardial access compared to the commercially available trocar in all tests. Aim 2: Demonstrate stable pacing parameters in a chronic pacing study. We will compare the chronic pacing performance of leads implanted with the PeriPath tool to leads implanted with the EndoPath trocar. The 12-week study will use a porcine animal model with a growth rate equivalent to a newborn. We will measure pacing outcomes as well as device usability and tissue healing. We will combine the results from Aim 1 to request an investigational device exemption (IDE). Success is defined as superior usability, stable pacing parameters, and better tissue healing scores for the PeriPath tool compared with EndoPath. Aim 3: Perform a first in human feasibility clinical study using PeriPath to implant a commercial pacemaker lead. Using the IDE obtained in Aim 2, we will request institutional review board (IRB) approval at Children’s National (CN) to implant a commercially available pacing lead in a five patient feasibility study. The study will demonstrate safety and efficacy of the PeriPath device. Lead stability and pacing parameters will be monitored. Success is defined by completion of the human feasibility study, and submission of a 510(k) application. This research could have a transformative impact in changing current clinical practice by converting an open surgical approach to a minimally invasive percutaneous procedure. While the study design focuses on the unique needs of infants and children with congenital heart disease, extrapolation of these findings may benefit thousands of adult patients who have indications for cardiac resynchronization therapy but do not achieve successful implantation due to lack of transvenous access or adequate coronary sinus venous tributaries to pace key locations in the left ventricle, which could be resolved with our proposed tools and techniques.

项目摘要 每年，美国近7200名婴儿出生 需要在生命的第一年内进行手术干预的心脏病。对于婴儿和年轻人 心律异常的儿童，介入治疗可能特别困难，因为 它们的脉管系统和/或先天性异常的大小通常排除在跨性别 植入心脏装置（例如太空人或除颤器）的方法。结果，婴儿 必须进行胸骨切开术或胸腔切开术才能进入心脏的心外膜表面。我们有 开发了一种新颖的微创心包访问工具，以提供节奏和定义 在内窥镜直接可视化下，导致心脏的心外膜表面。利用 该工具，我们假设我们可以安全有效地提供起搏和定义疗法 通过一个小端口。通过使用经皮方法，这应该减轻疼痛和风险 感染，减少程序时间并最大程度地减少开放的操作并发症 手术方法。此外，该过程的直接可视化使其比盲目更安全 心包穿刺。我们的团队利用心脏的未成熟猪植入 设备并证明经皮方法与开放一样安全有效 手术技术。 该II阶段SBIR项目的具体目标是证明上心 与使用临床前动物模型相比 婴儿生长速率，然后是人类（FIH）临床试验以加速调节 Peripath工具的批准和商业化。在这项工作中，我们将完成以下内容 3个具体目的： 目的1：证明优越的性能和可用性比商业套管理 通过设备性能和在组织板中的处理进行测量。我们将进行飞行员验证 根据FDA法规构建Peripath设备。设备将受到 与使用A的内齿式套管相比，可用性，验证和验证测试和结果 双方测试。成功定义为佩里帕斯（Peripath）达到了卓越的性能和 与所有测试中的市售套道球相比，心包通道。 AIM 2：在一项慢性起搏研究中展示稳定的起搏参数。我们将比较 植入佩里径工具的铅的慢性起搏性能，植入了铅的铅 室内套管。这项为期12周的研究将使用具有增长率的猪动物模型 相当于新生儿。我们将测量起搏结果以及设备可用性和组织 康复。我们将结合AIM 1的结果，要求豁免投资设备 （IDE）。成功定义为卓越的可用性，稳定的起搏参数和更好的组织 与室内变态相比，佩里径工具的愈合得分。 AIM 3：使用Peripath进行人类可行性临床研究进行第一次植入 商业空间制造商领导。使用AIM 2中获得的IDE，我们将要求机构审查 董事会（IRB）在儿童国家（CN）批准植入市售起搏线索 在一项五项患者可行性研究中。该研究将证明佩里氏症的安全性和效率 设备。铅稳定性和起搏参数将被监视。成功是通过完成定义的 人类的可行性研究和提交510（k）申请。 这项研究可能会对改变当前临床实践的变革影响 将开放手术方法转换为微创经皮手术。而 研究设计的重点是婴儿和先天性心脏病的独特需求， 这些发现的推断可能会使数千名有指示的成年患者受益 心脏重新同步疗法，但由于缺乏 横向通道或足够的冠状窦静脉支流到太空关键位置 左心室，可以通过我们提出的工具和技术来解决。