Optimal Management of LVOTO

Optimal Management of Critical Left Outflow Tract Obstruction (LVOTO)

  • Clinical Trial Information

    Trial Contact: Kube, Alicia

    Trial Phone: 321.841.7485

  • IRB No: 15.078.06

    Protocol Abbrev: LVOTO-CHSS

    Principal Investigator: William M. Decampli, MD

    Age Group: Pediatric

  • Objective

    1). Assemble a multi-institutional inception cohort of infants with critical LVOTO undergoing all currently available and future treatment strategies.
    2). Determine morphologic correlates of physiology prior to intervention in critical left ventricular outflow tract obstruction.
    3). Identify risk factors that affect outcomes.
    4). Determine the value of emerging management strategies.
    5). Assess late outcomes including functional health status, quality of life, developmental outcomes, and identification of electrophysiological and other complications.

  • Key Eligibility

    Inclusion Criteria:
    -Any neonate (≤ age 30 days at admission to a CHSS institution), date of admission after December 31, 2004, with AV & VA concordance whose left ventricular outflow tract obstruction precludes an adequate systemic cardiac output through the aortic valve.

    Exclusion Criteria:
    -First intervention at a non-CHSS institution
    -AV or VA discordance
    -Atrioventricular Septal Defect