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

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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.