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，美国有近7，200名婴儿出生时患有复杂的先天性 需要在出生后第一年内进行手术干预的心脏病。的婴幼 儿童心律异常，介入治疗可能特别困难， 其脉管系统尺寸和/或先天性异常通常排除了经静脉 用于植入心脏装置（例如起搏器或除颤器）的方法。因此，婴儿 必须进行胸骨切开术或胸廓切开术以进入心脏的心外膜表面。我们有 开发了一种新型微创心包穿刺工具，用于起搏和除颤 在内窥镜的直接观察下通向心脏的心外膜表面。利用 我们假设我们可以安全有效地提供起搏和除颤治疗， 一个小小的港口。通过使用经皮方法，这应该减少疼痛和风险 感染，减少手术时间，并尽量减少手术并发症， 手术入路此外，直接可视化的程序，使它比盲目更安全 心包穿刺我们的团队利用未成熟的猪模型植入心脏 设备，并证明经皮方法是安全和有效的开放 手术技术。 本阶段II SBIR项目的具体目标是证明上级心包 使用临床前动物模型与市售套管针进行比较的入路和心外膜起搏 与婴儿生长速度，其次是第一次在人类（FIH）临床试验，以加快监管 PeriPath工具的批准和商业化。在这项工作中，我们将完成以下工作 3个具体目标： 目标1：证明与市售穿刺器上级， 通过器械性能和在组织板中的处理进行测量。我们将进行试点验证 根据FDA法规构建PeriPath器械。器械将经受 与使用的EndoPath穿刺器相比的可用性、验证和确认测试及结果 双单侧检验成功的定义是：PeriPath实现了上级性能， 在所有试验中，与市售穿刺器相比，心包穿刺。 目的2：在慢性起搏研究中证明稳定的起搏参数。我们将比较 使用PeriPath工具植入的电极导线与使用 EndoPath穿刺器。这项为期12周的研究将使用猪动物模型， 相当于新生儿。我们将测量起搏结局以及器械可用性和组织 治愈我们将结合目标1的结果联合收割机申请试验用器械豁免 （IDE）.成功定义为上级可用性、稳定的起搏参数和更好的组织 与EndoPath相比，PeriPath工具的愈合评分。 目的3：使用PeriPath植入一个植入物进行首次人体可行性临床研究。 市售起搏器电极导线。使用目标2中获得的IDE，我们将请求进行机构审查 在Children's National（CN）获得IRB批准，植入市售起搏电极导线 五个病人的可行性研究。本研究将证明PeriPath的安全性和有效性 设备.将监测电极导线稳定性和起搏参数。成功的定义是完成 人体可行性研究，并提交510（k）申请。 这项研究可能会对改变目前的临床实践产生变革性的影响， 将开放手术方法转换为微创经皮手术。而 研究设计侧重于患有先天性心脏病的婴儿和儿童的独特需求， 这些发现的外推可能会使数千名有适应症的成年患者受益， 心脏栓塞治疗，但由于缺乏 经静脉入路或适当的冠状窦静脉分支，以起搏 左心室，这可以用我们提出的工具和技术来解决。