Clinical Research Directory

TORCH-LATAM-003: Regional Advanced-Therapy Pathways for Congenital Heart Disease

TORCH-LATAM-003 is a pragmatic stepped-wedge cluster randomized trial evaluating a regional pathway for children and adults with congenital heart disease and advanced cardiac and/or respiratory failure who may require heart, lung, or heart-lung transplantation, mechanical circulatory or extracorporeal support, or another regulated advanced-therapy pathway. Clusters transition from usual local pathways to TORCH-CATP. The primary outcome is completion of the prespecified multidisciplinary evaluation and documentation of an advanced-pathway decision within 90 days after enrollment. The study also evaluates barriers, authorized pathway or waiting-list activation, longitudinal status, advanced support, definitive therapy, and clinical outcomes. Donor-organ and matching events are captured only where legally authorized and do not replace national allocation systems or transplant-center decisions.