TORCH-LATAM-004 is a pragmatic stepped-wedge cluster randomized trial evaluating a regional pathway for adults with advanced heart failure secondary to acquired or structural heart disease who may require heart or combined transplantation, mechanical circulatory or extracorporeal support, advanced structural intervention, or another regulated advanced-therapy pathway. Clusters transition from usual local pathways to TORCH-AATP. 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, mechanical support, definitive therapy, external regulated pathways, 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.
Adult aged 18 years or older at informed consent.
Documented acquired or structural heart disease with advanced heart failure meeting a 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.
Congenital heart disease as the primary condition, or absence of a documented pathophysiological relationship between acquired or structural heart disease and advanced heart failure.
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 advanced-pathway decision were already completed and remain clinically current before enrollment.
Sequential
TORCH Adult Advanced Therapies Pathway (TORCH-AATP)
Other interventionA multicomponent health-services pathway that standardizes identification, referral, multidisciplinary adult advanced-heart-failure 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 Adult Advanced-Therapy Evaluation and Documented Pathway Decision Within 90 Days
Percentage of eligible enrolled participants who complete the prespecified multidisciplinary adult 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 adult 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
Collaborator
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