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.
Child or adult of any age with congenital heart disease; enrollment of minors requires parent or legal-representative permission and assent when applicable.
Congenital heart disease with advanced cardiac and/or respiratory failure, associated pulmonary hypertension, or another protocol-defined trigger for specialized advanced-therapy evaluation.
Identification within an activated TORCH network cluster with an operational route to at least one authorized advanced-therapy or transplant center.
Ability to complete protocol-defined follow-up directly or through an authorized network pathway.
Absence of congenital heart disease as the underlying condition defining the advanced cardiac and/or respiratory-failure pathway.
No authorized route for protocol evaluation or follow-up at the time of enrollment.
Unable or unwilling to provide informed consent or legally authorized permission when required.
The prespecified multidisciplinary evaluation and advanced-pathway decision were already completed and remain clinically current before enrollment.
Sequential
TORCH Congenital Advanced Therapies Pathway (TORCH-CATP)
Other interventionA 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.
Completion of Multidisciplinary Congenital Advanced-Therapy Evaluation and Documented Pathway Decision Within 90 Days
Percentage of eligible enrolled participants who complete the prespecified multidisciplinary congenital advanced-therapy evaluation and have a documented advanced-pathway decision within 90 days after enrollment. APD-A, APD-B, APD-D, APD-E, APD-F, APD-G, and APD-H count as completed decisions when the minimum evaluation is complete. APD-C denotes incomplete evaluation and is not counted as success. Death, irreversible deterioration, or missing evidence before day 90 is not counted as success unless the minimum evaluation and a valid decision were documented.
Activation of an Authorized Advanced-Therapy Pathway or Official Waiting List
Percentage of participants with a qualifying advanced-pathway decision who achieve documented activation of an authorized pathway or official waiting list. Enrollment alone is not activation.
Time to Completed Multidisciplinary Evaluation and Advanced-Pathway Decision
Time from enrollment to completion of the prespecified multidisciplinary evaluation and documentation of a valid advanced-pathway decision.
Redirection of the Advanced-Therapy Pathway
Percentage of enrolled participants with a documented change in intended advanced therapy or destination pathway, with origin, destination, authority, and reason recorded.
Waiting-List Status or Urgency Transition
Number and distribution of documented waiting-list status or urgency transitions by reason among participants with an official waiting-list episode.
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CardioVision International Tech, S.A.S. de C.V.
Lead sponsor
Advanced Science Technologies S.A.S.
Collaborator
Advanced Sciences Technologies, S.A. de C.V.
Collaborator
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