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TORCH-LATAM-002: Regional Pathway for Adult Heart Transplant Evaluation and Candidacy
Sponsor: CardioVision International Tech, S.A.S. de C.V.
Summary
TORCH-LATAM-002 is a pragmatic stepped-wedge cluster randomized trial evaluating an integrated regional pathway for adults with advanced heart failure who require specialized heart transplant evaluation and a documented candidacy decision. Participating network clusters transition from usual local pathways to the TORCH Adult Heart Transplant Evaluation and Candidacy Pathway. The primary outcome is completion of multidisciplinary evaluation and a documented transplant-candidacy decision within 90 days after enrollment. The study also examines pathway activation, barriers, clinical outcomes, waiting-list trajectories, and traceable donor-organ opportunities. Enrollment does not constitute placement on an official waiting list, organ allocation, or authorization of cross-border care.
Official title: A Stepped-Wedge Cluster Randomized Trial of the TORCH Adult Heart Transplant Evaluation and Candidacy Pathway for Adults With Advanced Heart Failure in Latin America
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
360
Start Date
2027-03-30
Completion Date
2031-03-30
Last Updated
2026-09-23
Healthy Volunteers
No
Interventions
TORCH Adult Heart Transplant Evaluation and Candidacy Pathway
A multicomponent health-services pathway that standardizes identification, referral, multidisciplinary evaluation, candidacy documentation, barrier navigation, longitudinal wait-list status, donor-organ opportunity traceability, and authorized information exchange across activated network nodes. The pathway supports but does not replace institutional or governmental clinical, listing, allocation, or regulatory decisions.