Congenital heart disease can progress to advanced cardiac or cardiopulmonary failure requiring heart, heart-lung, or, in selected congenital conditions, bilateral lung transplantation with cardiac repair. Access to transplant evaluation and organ utilization can vary across regions and institutions, and potential candidates who are never referred or evaluated are not represented in conventional waiting-list statistics. TORCH-LATAM is a pragmatic multicenter stepped-wedge cluster-randomized effectiveness-implementation trial evaluating the TORCH Integrated Transplant Access Pathway (TORCH-ITAP) in Latin America. Regional network clusters transition in a randomized sequence from usual care to TORCH-ITAP. The pathway standardizes early identification and referral, a common recipient dataset, multidisciplinary candidacy adjudication, structured donor-organ assessment, immunologic and anatomic-physiologic matching, preservation and transport traceability, and navigation of clinical, regulatory, logistical, and financial barriers. The primary outcome is the proportion of enrolled recipient participants who complete a standardized multidisciplinary transplant evaluation and receive a documented candidacy decision within 90 days. Secondary outcomes include activation of an official transplant pathway or waitlist where applicable, transplantation within 12 months, pretransplant death or irreversible deterioration, donor-organ utilization, post-transplant safety and survival, and implementation outcomes. Recipient participants constitute the ClinicalTrials.gov enrollment; donors, organs, donor-recipient matches, preservation strategies, and transplant episodes are nested analytic units. TORCH-ITAP does not allocate organs and does not supersede national transplant laws, authorized transplant programs, or governmental requirements for cross-border organ movement.
Confirmed congenital heart disease.
Age from birth with no protocol-defined upper age limit.
Advanced cardiac, pulmonary vascular, or cardiopulmonary deterioration meeting contemporary international criteria for transplant referral/evaluation, or previously documented transplant candidacy by an authorized program.
Clinical presentation within the TORCH scope: heart transplantation; heart-lung transplantation; or, in selected congenital heart disease, bilateral lung transplantation with cardiac repair after multidisciplinary adjudication.
Absence of congenital heart disease or a transplant indication outside the TORCH congenital-heart-disease scope.
No protocol-defined indication for transplant referral/evaluation after standardized review.
A contemporary absolute contraindication to all transplant strategies applicable to the participant that is confirmed by multidisciplinary adjudication and is not considered reversible or re-evaluable under the protocol.
Inability to obtain required informed consent/assent or to collect the minimum essential baseline dataset.
Crossover
TORCH Integrated Transplant Access Pathway (TORCH-ITAP)
Other interventionTORCH-ITAP is a multicomponent regional health-services pathway that standardizes early identification and referral, a common recipient dataset, multidisciplinary candidacy adjudication, structured donor-organ assessment, immunologic and anatomic-physiologic matching, preservation and transport traceability, and navigation of clinical, regulatory, logistical, and financial barriers. It supports authorized transplant pathways but does not allocate organs or supersede applicable law, competent authorities, or institutional authorization.
Percentage of Participants Completing Standardized Multidisciplinary Transplant Evaluation With a Documented Candidacy Decision
Percentage of enrolled recipient participants who complete the protocol-defined minimum multidisciplinary transplant evaluation and receive a final documented candidacy decision within 90 days. Final decisions include candidate/active pathway, candidate with a documented reversible condition/temporarily inactive status, not a candidate under current conditions, or an alternative transplant strategy within protocol scope. Deferred/incomplete evaluation does not count as success. Participants who die before final decision remain in the denominator and are classified as failures.
Activation of an Official Transplant Pathway or Waitlist
Percentage of TORCH-adjudicated candidates who enter an active authorized transplant pathway or official waitlist when applicable under local rules.
Receipt of Heart, Heart-Lung, or Selected Bilateral Lung Transplantation With Cardiac Repair
Cumulative incidence of protocol-scope transplantation after enrollment, with death or irreversible deterioration treated as competing events in prespecified analyses.
Pretransplant Death or Irreversible Clinical Deterioration
Cumulative incidence of death or deterioration that permanently prevents transplantation before transplantation.
Utilization of TORCH-Evaluated Donor Organs
Percentage of donor organs meeting the prespecified TORCH donor-organ opportunity denominator that are implanted. Final disposition is classified as implanted, recovered but not implanted, or not recovered. Prespecified reasons for non-use are recorded.
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CardioVision International Tech, S.A.S. de C.V.
Lead sponsor
Advanced Science Technologies
Collaborator
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