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NCT07837024Not yet recruiting

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

A Stepped-Wedge Cluster Randomized Trial of the TORCH Congenital Advanced Therapies Pathway for Children and Adults With Congenital Heart Disease in Latin America

Source: ClinicalTrials.gov · Last updated 13 Oct 2026

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Study type
Interventional
Enrollment
360 (estimated)
First submitted
8 Sept 2026
Start date
30 Mar 2027
Primary completion date
30 Mar 2029
Lead sponsor
CardioVision International Tech, S.A.S. de C.V.
NCT number
NCT07837024

What you commit to

  • Study type: Interventional
  • Planned participants: 360
  • From 30 Mar 2027 to the primary completion date, 30 Mar 2029
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Absence of congenital heart disease as the underlying condition defining the advanced cardiac and/or respiratory-failure pathway.

Other

  • 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.

Who the study is looking for

  • 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.

Age in the registry: 0 days to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.