Texas Children’s Hospital hosted a two-day training workshop on June 25-26 for the PumpKIN clinical trial protocol attended by cardiovascular surgeons and cardiologists from medical centers throughout the United States.
Texas Children’s Hospital is one of 22 hospitals selected as a clinical site in an NHLBI trial of new technology for children, infants and neonates with severe heart failure who need mechanical circulatory support. This study, PumpKIN (Pumps for Kids, Infants, Neonates), will randomize candidates to one of two types of advanced heart support devices as a bridge to transplant – the infant Jarvik 2000 system or the FDA-approved Berlin Heart Pediatric EXCOR® ventricular assist device (VAD).
Tim Baldwin, PhD, NHLBI project officer for contract research on pediatric ventricular devices, discussed the protocol, study design and trial eligibility for this five-year study. Dr. Robert Jarvik, designer and biomedical engineer of the first artificial heart used as a permanent implant in a human being, spoke on the development of the Jarvik 2000 device and noted the critical need for devices manufactured specially for children. The cardiovascular surgeons and cardiologists also participated in lab training.
“A critical need exists for long-term mechanical circulatory support for children with severe heart failure, many of whom die while waiting for a heart transplant. This clinical trial will hopefully give us another option in pediatric circulatory support devices so that we can continue to make progress in treating these sick children,” said Dr. Charles D. Fraser, Texas Children’s surgeon-in-chief.