TORCH-LATAM: A Regional Pathway to Improve Transplant Evaluation for Congenital Heart Disease

Sponsor
CardioVision International Tech, S.A.S. de C.V.
Study ID
NCT07799272
Status
Not Yet Recruiting

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Conditions

  • Congenital Heart Disease

Eligibility Criteria

Sex
ALL
Age
0 Days - N/A
Healthy Volunteers
Not accepted

Interventions

  • TORCH Integrated Transplant Access Pathway (TORCH-ITAP) — OTHER
    TORCH-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.

Study Details

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.

Key Dates

First listed
Sep 2, 2026
Start date
Mar 31, 2027
Status verified
Aug 2026
Primary completion
Sep 30, 2029
Completion
Jun 30, 2031

Study Design

Enrollment
600 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • No Intervention: Usual Care Phase
    Participants receive the site-specific usual transplant referral and evaluation pathway. Minimum study measurement is collected without activation of TORCH-ITAP.
  • Experimental: TORCH-ITAP Phase
    The regional network implements TORCH-ITAP, including standardized identification and referral, common-data assessment, candidacy adjudication, donor-organ and match workflow, and structured navigation and traceability.

Primary Outcome Measure

Percentage of Participants Completing Standardized Multidisciplinary Transplant Evaluation With a Documented Candidacy Decision [ Time Frame: Within 90 days after formal trial enrollment ]

Central Contacts

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