The objective of this work is to transition the development of a ventricular assist system designed to support neonates and small children from animal testing into a single center clinical trial. The 2001 report of the NHLBI) sponsored Task Force on Research in Pediatric Cardiovascular Disease identified the pressing need for novel systems to support children severely compromised by congenital cardiovascular malformations, cardiomyopathies, congestive heart failure, arrhythmias, myocardial infarctions and coronary artery aneurysms. The pediatric ventricular assist device under development by Levitronix and its development partner the University of Pittsburgh (UOP) is intended to fulfill the need for acute and temporary cardiac life support (up to 4 weeks) in infants and small children. Our goal will be to extend technology associated with a small-scale paracorporeal MagLev centrifugal blood pump, to create a clinical product for infants and small children. Uniquely, this pump has no seals, bearings or other movable parts that are traditionally associated with thrombus formation or mechanical failure. In Phase I of the project, we demonstrated the soundness of this technology for the pediatric application through a series of in vitro and in vivo experiments. In Phase II of the project, we optimized pump design to accommodate the hemodynamic conditions typical for the pediatric patient and demonstrated effective hemodynamic performance and biocompatibility in a series of in vivo implants simulating clinically realistic conditions. Acknowledging the importance and clinical need of advancing this technology rapidly into the clinical arena, we propose here a Phase II Continuation to support the completion of the hardware development to its final clinical form, performance of the final series of pre-clinical animal testing using the clinical-form hardware; and, the initiation of clinical trials.
Our specific Aims i nclude:
Aim 1 : Characterize the in vitro hemodynamic properties and hemocompatibility of Levitronix pediatric VAD-cannula system (PediVAS).
Aim 2 : Determine PediVAS function and biocompatibility in the juvenile ovine model.
Aim 3. Conduct preliminary clinical safety and efficacy trials of the Levitronix PediVAS in infants and children with heart failure. In achieving these goals, these results will lead to a novel therapeutic opportunity to improve the care of children with congenital and/or acquired cardiac defects. By achieving the above specific aims, we intend to fabricate fully verified and validated hardware, establish component reliability, and conduct a pilot phase clinical trial. Levitronix has substantial experience in fabricating clinical-use blood pump hardware and meeting regulatory requirements for clinical trial testing. The University of Pittsburgh and Children's Hospital have more than 20 years of experience in the clinical testing and validation of ventricular assist devices for adult and pediatric patients. The research team, consisting of Levitronix and University of Pittsburgh, is thus positioned to conduct the first FDA approved clinical trial of a pediatric VAD. If successful, these results will lead to a novel therapeutic option for the care of children with congenital and/or acquired cardiac defects. 7. Project Narrative The PediVAS system is being developed to address the need to support children with severely compromised heart conditions. The pediatric ventricular assist device is intended to fulfill the need for acute and temporary cardiac life support (up to 4 weeks) in infants and small children. ? ? ?
