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NOT YET RECRUITING
NCT07837024
NA

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

Sponsor: CardioVision International Tech, S.A.S. de C.V.

View on ClinicalTrials.gov

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

Interventions

OTHER

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.