TY - GEN AU - Almond,Christopher S AU - Buchholz,Holger AU - Massicotte,Patricia AU - Ichord,Rebecca AU - Rosenthal,David N AU - Uzark,Karen AU - Jaquiss,Robert D B AU - Kroslowitz,Robert AU - Kepler,Mary Beth AU - Lobbestael,Aaron AU - Bellinger,David AU - Blume,Elizabeth D AU - Fraser,Charles D AU - Bartlett,Robert H AU - Thiagarajan,Ravi AU - Jenkins,Kathy TI - Berlin Heart EXCOR Pediatric ventricular assist device Investigational Device Exemption study: study design and rationale SN - 1097-6744 PY - 2011///1101 KW - Adolescent KW - Child KW - Child, Preschool KW - Extracorporeal Membrane Oxygenation KW - Female KW - Follow-Up Studies KW - Heart Failure KW - diagnosis KW - Heart Transplantation KW - Heart-Assist Devices KW - Humans KW - Infant KW - Infant, Newborn KW - Male KW - Preoperative Care KW - instrumentation KW - Prospective Studies KW - Recovery of Function KW - physiology KW - Single-Blind Method KW - Treatment Outcome KW - Ventricular Function N1 - Publication Type: Clinical Trial; Comparative Study; Journal Article; Multicenter Study; Research Support, U.S. Gov't, P.H.S UR - https://doi.org/10.1016/j.ahj.2011.05.026 ER -