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TORCH-LATAM-003: Regional Advanced-Therapy Pathways for Congenital Heart Disease
Sponsor: CardioVision International Tech, S.A.S. de C.V.
Summary
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.
Official title: A Stepped-Wedge Cluster Randomized Trial of the TORCH Congenital Advanced Therapies Pathway for Children and Adults With Congenital Heart Disease in Latin America
Key Details
Gender
All
Age Range
0 Days - Any
Study Type
INTERVENTIONAL
Enrollment
360
Start Date
2027-03-30
Completion Date
2031-03-30
Last Updated
2026-10-13
Healthy Volunteers
No
Conditions
Interventions
TORCH Congenital Advanced Therapies Pathway (TORCH-CATP)
A multicomponent health-services pathway that standardizes identification, referral, multidisciplinary congenital-heart-disease evaluation, advanced-pathway decision documentation, barrier navigation, longitudinal waiting-list and support status, authorized donor-organ and matching traceability, and secure information exchange. It does not assign organs, authorize therapies, or replace transplant-center or governmental decisions.