Minimally Invasive Epicardial Pacing in Infants and Children with Congenital Heart Disease

Children’s National Hospital
Washington, DC

Principal Investigator: Charles Berul, MD, Chief of Cardiology

We are proposing a novel lead attachment mechanism to improve chronic stability for pacing leads that are implanted on the outside of the heart without open chest surgery. This mechanism is targeted at infants, small children, and individuals with congenital heart disease who are unable to have a pacemaker placed through the traditional transvenous approach and for those who require temporary pacing wires not immediately concurrent with open cardiac surgery. We have developed four unique solutions that rely on an improved grasping mechanism of the cardiac tissue, increased surface area contact, and strain relief. The goal of this project is to demonstrate the feasibility of manufacturing such device, evaluate the fixation integrity and investigate the long-term stability of the prototype attachment mechanisms compared to standard leads in a chronic pig study

This project aims to the following:

1.     Demonstrate device feasibility by manufacturing the novel lead and performing ex vivo mechanical testing on the benchtop and in a recently developed pediatric cardiac simulation doll

2.     Demonstrate effectiveness of the lead by measuring the performance of the pacing system across a 3-month survival study in an immature animal model.