TORCH-LATAM-003: Regional Advanced-Therapy Pathways for Congenital Heart Disease

NCT07837024 | Not Yet Recruiting

• 1 other identifier: TORCH-LATAM-003
• Study Type: interventional
• Target: 360
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Congenital Heart Disease; Advanced Heart Failure; Respiratory Failure; Heart Transplantation; Lung Transplantation; Heart-Lung Transplantation

Keywords

congenital heart disease; pediatric; adult congenital heart disease; advanced heart failure; advanced respiratory failure; transplant candidacy; waiting list; mechanical circulatory support; ECMO; advanced therapies; implementation science; health services research; Latin America

Outcome Measures

Primary Outcomes (1)

• 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.

  Within 90 days after enrollment.

Secondary Outcomes (11)

• Activation of an Authorized Advanced-Therapy Pathway or Official Waiting List

  Within 180 days after the first documented advanced-pathway decision qualifying for activation.

• Time to Completed Multidisciplinary Evaluation and Advanced-Pathway Decision

  From enrollment to completed evaluation and documented advanced-pathway decision, assessed through 180 days.

• Redirection of the Advanced-Therapy Pathway

  Through 24 months after enrollment.

• Waiting-List Status or Urgency Transition

  At each documented waiting-list transition through 24 months after enrollment.

• Initiation of Temporary Mechanical Circulatory or Extracorporeal Life Support

  Through 24 months after enrollment.

Study Arms (2)

TORCH-CATP Intervention Period

EXPERIMENTAL

Participants enrolled while their cluster is assigned to the intervention period receive the TORCH Congenital Advanced Therapies Pathway, including protocolized identification and referral, multidisciplinary evaluation, pathway-decision adjudication, barrier navigation, pathway and waiting-list status tracking, and traceable donor-organ opportunity coordination when applicable.

Other: TORCH Congenital Advanced Therapies Pathway (TORCH-CATP)

Usual Local Pathway Period

NO INTERVENTION

Participants enrolled before their cluster transitions to TORCH-CATP receive locally available referral, evaluation, treatment, support, and transplant-candidacy processes. Study data collection does not alter the authority of local programs or competent authorities.

Interventions

TORCH Congenital Advanced Therapies Pathway (TORCH-CATP) OTHER

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.

TORCH-CATP Intervention Period

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:

• Child or adult of any age with congenital heart disease; enrollment of minors requires parent or legal-representative permission and assent when applicable.
• Congenital heart disease with advanced cardiac and/or respiratory failure, associated pulmonary hypertension, or another protocol-defined trigger for specialized advanced-therapy evaluation.
• Identification within an activated TORCH network cluster with an operational route to at least one authorized advanced-therapy or transplant center.
• Ability to complete protocol-defined follow-up directly or through an authorized network pathway.
• Provision of informed consent by the participant or legally authorized representative, and assent when applicable, according to local requirements.

You may not qualify if:

• Absence of congenital heart disease as the underlying condition defining the advanced cardiac and/or respiratory-failure pathway.
• No authorized route for protocol evaluation or follow-up at the time of enrollment.
• Unable or unwilling to provide informed consent or legally authorized permission when required.
• The prespecified multidisciplinary evaluation and advanced-pathway decision were already completed and remain clinically current before enrollment.

Sponsors & Collaborators

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

MeSH Terms

Conditions

Heart Defects, Congenital; Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Respiration Disorders; Respiratory Tract Diseases

Study Officials

• Eliecer Villamizar De La Hoz, MD

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eliecer Villamizar De La Hoz, MD

CONTACT

+50370878226; eliecerevillamizar@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Clusters are randomized to the sequence in which they transition from usual local pathways to the TORCH congenital advanced-therapies pathway. Repeated cross-sectional cohorts are enrolled in each cluster-period.

Study Record Dates

• First Submitted: September 8, 2026
• First Posted: September 23, 2026
• Study Start (Estimated): March 30, 2027
• Primary Completion (Estimated): March 30, 2029
• Study Completion (Estimated): March 30, 2031
• Last Updated: September 23, 2026

Record last verified: 2026-09