TORCH-LATAM-002: Regional Pathway for Adult Heart Transplant Evaluation and Candidacy

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.

Inclusion Criteria: * Age 18 years or older. * Advanced heart failure or acquired or structural heart disease meeting a protocol-defined trigger for specialized heart transplant evaluation. * Identification within an activated TORCH network cluster with an operational route to at least one authorized transplant center. * Ability to complete the protocol-defined follow-up directly or through an authorized network pathway. * Provision of informed consent according to applicable requirements. Exclusion Criteria: * Primary congenital heart disease managed under the pediatric or congenital TORCH protocol. * No authorized route for protocol evaluation or follow-up at the time of enrollment. * Unable or unwilling to provide informed consent when required. * The prespecified multidisciplinary evaluation and transplant-candidacy decision were already completed before the enrollment reference time.