An interventional study of TORCH Integrated Transplant Access Pathway (TORCH-ITAP) in Congenital Heart Disease, sponsored by CardioVision International Tech, S.A.S. de C.V.. Not yet recruiting. Open to participants aged 0 Days and older. Per ClinicalTrials.gov, last updated 2026-10-13.
Sponsored by CardioVision International Tech, S.A.S. de C.V. · Not applicable, Interventional, and Health services research
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.
TORCH-LATAM evaluates a regional health-services intervention for pediatric and adult participants with congenital heart disease who meet protocol-defined international triggers for transplant referral/evaluation or who already have documented transplant candidacy. The intervention begins before official waitlisting. It follows a traceable cascade from identification and screening through consent and enrollment, standardized multidisciplinary assessment, candidacy adjudication, activation of an authorized transplant pathway, donor-organ opportunity assessment, immunologic and anatomic-physiologic matching, procurement, preservation, transport, transplantation, and follow-up.
The unit of randomization is a TORCH Regional Network Cluster rather than an individual hospital. A cluster is a functional network anchored in an authorized transplant center and may include referral/evaluation sites, donor-origin hospitals, procurement or preservation functions, and regional data coordination. Clusters begin in usual care and transition at randomized prespecified steps to TORCH-ITAP; after transition they remain exposed to the intervention.
TORCH uses layered eligibility. Recipient eligibility is separate from donor-organ eligibility, immunologic compatibility, anatomic-physiologic matching, and final transplant-episode feasibility. Donation after brain death and donation after circulatory death are donation pathways and are not synonymous with extended-criteria donation. Procurement/reperfusion strategies, preservation technologies, infectious or malignancy transmission risk, and extended preservation/transport exposure are captured as separate dimensions. Preservation technologies are not randomized by the parent protocol unless a future prespecified substudy introduces randomized assignment.
The primary confirmatory analysis follows intention-to-treat according to randomized cluster-period assignment. The primary outcome is analyzed with a generalized linear mixed model including intervention and calendar period as fixed effects and cluster as a random effect. Time-to-transplant and pretransplant death or irreversible deterioration are analyzed using competing-risk/time-to-event methods. Donor-organ utilization and preservation analyses use nested multilevel or observational methods appropriate to their unit of analysis. Predictive modeling is exploratory and is separated from the confirmatory analysis.
The digital platform implements a version-controlled Common Data Model with role-based access, audit trails, timestamps, structured reasons for clinical and operational decisions, and interoperable data elements. Platform development and testing with synthetic or non-identifiable data may occur before participant enrollment and does not constitute the ClinicalTrials.gov Study Start Date.
TORCH-LATAM does not create an organ allocation authority. Official listing, organ allocation, procurement, transplantation, and any cross-border movement remain subject to applicable law, competent authorities, institutional authorization, informed consent, and traceability.
991 studies on the registry are indexed under Heart Defects, Congenital; 251 are open to participants now.
This study's planned enrollment of 600 is above the median of 60 across 507 interventional studies indexed under Heart Defects, Congenital.
Browse Heart Defects, Congenital studies →CardioVision International Tech, S.A.S. de C.V. is the lead sponsor of 4 studies on the registry; 4 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants receive the site-specific usual transplant referral and evaluation pathway. Minimum study measurement is collected without activation of TORCH-ITAP.
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.
Other: TORCH Integrated Transplant Access Pathway (TORCH-ITAP)
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.
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.
Time frame: Within 90 days after formal trial enrollment
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.
Time frame: Within 6 months after candidacy decision
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.
Time frame: Within 12 months after enrollment
Pretransplant Death or Irreversible Clinical Deterioration
Cumulative incidence of death or deterioration that permanently prevents transplantation before transplantation.
Time frame: Within 12 months after enrollment
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.
Time frame: At final disposition of each donor organ (implantation or documented non-use)
Patient and Graft Survival
Organ-specific patient and graft survival after transplantation.
Time frame: 30 days, 90 days, and 1 year after transplantation
No study locations are listed for this record.
Plan to share: Undecided
Start is estimated for Mar 2027; primary completion for Sep 2029, 30 months later.
Of 223 interventional studies with no phase under Heart Defects, Congenital, half reached primary completion within 34 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 57. This study's planned 30 months is below that.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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