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

NCT07799272 | Not Yet Recruiting DMC

• 1 other identifier: TORCH-LATAM-001
• Study Type: interventional
• Target: 600
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Congenital Heart Disease

Keywords

Heart Transplantation; Heart-Lung Transplantation; Lung Transplantation; Health Services Research

Outcome Measures

Primary Outcomes (1)

• 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.

  Within 90 days after formal trial enrollment

Secondary Outcomes (5)

• Activation of an Official Transplant Pathway or Waitlist

  Within 6 months after candidacy decision

• Receipt of Heart, Heart-Lung, or Selected Bilateral Lung Transplantation With Cardiac Repair

  Within 12 months after enrollment

• Pretransplant Death or Irreversible Clinical Deterioration

  Within 12 months after enrollment

• Utilization of TORCH-Evaluated Donor Organs

  At final disposition of each donor organ (implantation or documented non-use)

• Patient and Graft Survival

  30 days, 90 days, and 1 year after transplantation

Study Arms (2)

Usual Care Phase

NO INTERVENTION

Participants receive the site-specific usual transplant referral and evaluation pathway. Minimum study measurement is collected without activation of TORCH-ITAP.

TORCH-ITAP Phase

EXPERIMENTAL

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)

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.

TORCH-ITAP Phase

Eligibility Criteria

• Age: 0 Days+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Availability of the minimum baseline dataset required for standardized multidisciplinary evaluation and risk stratification.
• Written informed consent from the participant or legally authorized representative, with assent and re-consent as applicable under local requirements.
• Ability to undergo protocol-defined longitudinal follow-up.
• For participants referred from a non-transplant site, an operational referral route within the participating network to at least one authorized transplant center must exist. Prior acceptance by that transplant center is not required for trial enrollment; completion of specialist evaluation and the candidacy decision are post-enrollment trial processes/outcomes.

You may not qualify if:

• 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.
• A legal, regulatory, or safety condition that prohibits participation in research at the enrolling site.

Sponsors & Collaborators

• CardioVision International Tech, S.A.S. de C.V.: lead
• Advanced Sciences Technologies, S.A. de C.V.: collaborator
• Advanced Science Technologies S.A.S.: collaborator

MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Eliecer Villamizar De La Hoz., MD

  CardioVision International Tech, S.A.S. de C.V.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eliecer Villamizar De La Hoz, MD

CONTACT

50370876226; eliecerevillamizar@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Participants, care providers, and investigators are open-label because TORCH-ITAP is an operational health-services pathway. Primary endpoint verification will be performed centrally by outcome assessors blinded to randomized cluster-period assignment where operationally feasible.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Stepped-wedge cluster-randomized trial represented in ClinicalTrials.gov as Crossover Assignment with two intervention conditions. Regional network clusters begin in usual care and cross over in a randomized prespecified sequence to TORCH-ITAP; once transitioned, a cluster remains exposed. New eligible recipient participants are enrolled consecutively within each cluster-period and are followed longitudinally after enrollment.

Study Record Dates

• First Submitted: August 27, 2026
• First Posted: September 2, 2026
• Study Start (Estimated): March 1, 2027
• Primary Completion (Estimated): September 1, 2029
• Study Completion (Estimated): June 1, 2031
• Last Updated: September 2, 2026

Record last verified: 2026-08