Characterization and Utilization of Therapeutic Cardiac Devices in Children with Congenital Heart Disease
This project aims to determine whether data capture of device utilization in a Pediatric Cardiac Catheterization Laboratory is possible across multiple different institutions. The pilot study is designed to begin to devise a global approach that will ultimately be applied across institutions and networks.
This Test-Case aims to determine if NESTcc can adequately capture a specific stent implantation in pulmonary arteries and systemic veins during congenital heart disease therapy. The stents being studied are of particular interest in pediatric patients. Successful implantation and use surveillance could provide the impetus for more robust outcome assessment, and subsequent possible label expansion. In addition, this project is characterizing the range of pediatric stent use at participating PEDSnet sites and developing a scalable approach to investigating pediatric device use in PCORnet networks.
Formal regulatory (U.S. Food and Drug Administration – FDA) approval for devices used in congenital heart disease is rare, and the majority are used “off-label” after adult approval. The lack of formal regulatory authorization and the potential cost of separate pediatric studies have both undermined industry development and constrained therapies in the pediatric space.
This study aims to allow for the collection of prevalence information across a consortium of multiple institutions. System protocols and conventions already established by NESTcc would serve as an ideal framework in the initial real-time phase of this project.