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.
Each TORCH regional network cluster is anchored in an authorized advanced-therapy or transplant center and may include activated evaluation, referral, congenital cardiology, pulmonary hypertension, intensive-care, mechanical-support, donor-origin, procurement, preservation, logistics, and data-coordination nodes. Children and adults with congenital heart disease may be identified at transplanting or non-transplanting centers when an authorized route to specialized evaluation exists. Authorized centers and competent authorities retain all legal and clinical authority for candidacy, waiting-list activation, organ acceptance, allocation, and transplantation. The recipient pathway records identification, referral, enrollment, completion of multidisciplinary congenital evaluation, a documented advanced-pathway decision, barrier management, activation of an authorized pathway or official waiting list, longitudinal clinical and support status, transplantation, regulated external-protocol enrollment, or an alternative outcome. Study enrollment is analytically distinct from advanced-therapy candidacy and official wait-list status. The pathway permits clinically documented redirection among heart, lung, heart-lung, or other authorized transplant evaluation; temporary or durable mechanical support; recovery; surveillance; palliative care; and independently governed investigational protocols. TORCH does not assign an investigational therapy, device, cell, organoid, or xenograft and does not infer efficacy or safety for such products. Where legally authorized, donor-organ and recipient pathways converge at traceable compatibility and offer episodes. Each decision, non-acceptance reason, reassignment, urgency change, distance, logistics constraint, and final disposition is time-stamped. TORCH does not create a supranational allocation authority or override governmental or institutional systems. Interoperability may range from audited manual transfer to structured documents, batch exchange, application programming interfaces, standards-based exchange, or validated remote-monitoring devices. Cross-border activity is activated only after applicable ethical, regulatory, institutional, data-protection, financial, and operational approvals.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
360
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.
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.
Time frame: Within 90 days after enrollment.
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 frame: Within 180 days after the first documented advanced-pathway decision qualifying for 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.
Time frame: From enrollment to completed evaluation and documented advanced-pathway decision, assessed through 180 days.
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.
Time frame: Through 24 months after enrollment.
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.
Time frame: At each documented waiting-list transition through 24 months after enrollment.
Initiation of Temporary Mechanical Circulatory or Extracorporeal Life Support
Percentage of enrolled participants with initiation of protocol-defined temporary mechanical circulatory support or extracorporeal life support; organ supported, configuration, and therapeutic intent are classified.
Time frame: Through 24 months after enrollment.
Durable Mechanical Support Implantation
Percentage of enrolled participants receiving protocol-defined durable mechanical circulatory or respiratory support; device category and therapeutic strategy are reported separately.
Time frame: Through 24 months after enrollment.
Transplantation by Organ Type
Percentage of enrolled participants who undergo heart, lung, or heart-lung transplantation, reported separately by organ type.
Time frame: Through 24 months after enrollment.
Survival Free From Irreversible Clinical Deterioration
Percentage of enrolled participants alive without protocol-defined irreversible deterioration that precludes the intended advanced-therapy pathway at each prespecified time point.
Time frame: At 90 days, 1 year, and 2 years after enrollment.
Resolution of Identified Barriers
Percentage of prespecified clinical, administrative, financial, regulatory, logistical, geographic, social, technological, or information barriers documented as resolved according to the barrier-specific rule; each barrier is the unit of analysis.
Time frame: Within 180 days after identification of each barrier.
Authorized Enrollment in an External Advanced-Therapy Protocol
Percentage of enrolled participants who provide protocol-specific consent and are formally enrolled in an independently governed advanced-therapy protocol. Referral, contact, screening, or APD-G alone is not enrollment. This outcome measures access and not efficacy or safety of the external product.
Time frame: 24 months after enrollment.
Utilization of TORCH-Evaluated Donor Organs
Percentage of donor organs meeting the prespecified evaluable-opportunity denominator that are implanted. Final disposition is classified as implanted, recovered but not implanted, or not recovered, with prespecified reasons for non-use recorded.
Time frame: At final disposition of each donor organ, during the perioperative/periprocedural period, including implantation, recovery without implantation, or documented non-use.
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