Congenital Heart DiseaseTORCH-003NCT07837024
TORCH-LATAM-003: Regional Advanced-Therapy Pathways for Congenital Heart Disease
A study testing TORCH Congenital Advanced Therapies Pathway (TORCH-CATP) in people with Congenital Heart Disease and Advanced Heart Failure, run by CardioVision International Tech, S.A.S. de C.V..
Trial 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… Read more about this study
- Who is it for?
- Ages 0 days and older
- Conditions the study is for
- Congenital Heart Disease, Advanced Heart Failure, Respiratory Failure
- What is being tested?
- TORCH Congenital Advanced Therapies Pathway (TORCH-CATP)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- No sites listed yet
- Study dates
- 30 Mar 2027to 30 Mar 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 days and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Stepped-Wedge Cluster Randomized Trial of the TORCH Congenital Advanced Therapies Pathway for Children and Adults With Congenital Heart Disease in Latin America
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.
Read the detailed description
Each TORCH regional network cluster is anchored in an authorized advanced-therapy or transplant center and may include activated evaluation, referral, congenital cardiology, pulmonary hypertension, intensive-care, mechanical-support, donor-origin, procurement, preservation, logistics, and data-coordination nodes. Children and adults with congenital heart disease may be identified at transplanting or non-transplanting centers when an authorized route to specialized evaluation exists. Authorized centers and competent authorities retain all legal and clinical authority for candidacy, waiting-list activation, organ acceptance, allocation, and transplantation.
The recipient pathway records identification, referral, enrollment, completion of multidisciplinary congenital evaluation, a documented advanced-pathway decision, barrier management, activation of an authorized pathway or official waiting list, longitudinal clinical and support status, transplantation, regulated external-protocol enrollment, or an alternative outcome. Study enrollment is analytically distinct from advanced-therapy candidacy and official wait-list status.
The pathway permits clinically documented redirection among heart, lung, heart-lung, or other authorized transplant evaluation; temporary or durable mechanical support; recovery; surveillance; palliative care; and independently governed investigational protocols. TORCH does not assign an investigational therapy, device, cell, organoid, or xenograft and does not infer efficacy or safety for such products.
Where legally authorized, donor-organ and recipient pathways converge at traceable compatibility and offer episodes. Each decision, non-acceptance reason, reassignment, urgency change, distance, logistics constraint, and final disposition is time-stamped. TORCH does not create a supranational allocation authority or override governmental or institutional systems.
Interoperability may range from audited manual transfer to structured documents, batch exchange, application programming interfaces, standards-based exchange, or validated remote-monitoring devices. Cross-border activity is activated only after applicable ethical, regulatory, institutional, data-protection, financial, and operational approvals.
- Conditions
- Congenital Heart Disease, Advanced Heart Failure, Respiratory Failure, Heart Transplantation, Lung Transplantation, Heart-Lung Transplantation
- Being tested
- TORCH Congenital Advanced Therapies Pathway (TORCH-CATP)
- 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
- Medical subject headings
- Heart Defects, Congenital, Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within 90 days after enrollment.
Secondary outcomes (11)
Activation of an Authorized Advanced-Therapy Pathway or Official Waiting List
Percentage of participants with a qualifying advanced-pathway decision who achieve documented activation of an authorized pathway or official waiting list. Enrollment alone is not activation.
Measured: Within 180 days after the first documented advanced-pathway decision qualifying for activation.
Time to Completed Multidisciplinary Evaluation and Advanced-Pathway Decision
Time from enrollment to completion of the prespecified multidisciplinary evaluation and documentation of a valid advanced-pathway decision.
Measured: From enrollment to completed evaluation and documented advanced-pathway decision, assessed through 180 days.
Redirection of the Advanced-Therapy Pathway
Percentage of enrolled participants with a documented change in intended advanced therapy or destination pathway, with origin, destination, authority, and reason recorded.
Measured: Through 24 months after enrollment.
Waiting-List Status or Urgency Transition
Number and distribution of documented waiting-list status or urgency transitions by reason among participants with an official waiting-list episode.
Measured: At each documented waiting-list transition through 24 months after enrollment.
Initiation of Temporary Mechanical Circulatory or Extracorporeal Life Support
Percentage of enrolled participants with initiation of protocol-defined temporary mechanical circulatory support or extracorporeal life support; organ supported, configuration, and therapeutic intent are classified.
Measured: Through 24 months after enrollment.
Durable Mechanical Support Implantation
Percentage of enrolled participants receiving protocol-defined durable mechanical circulatory or respiratory support; device category and therapeutic strategy are reported separately.
Measured: Through 24 months after enrollment.
Transplantation by Organ Type
Percentage of enrolled participants who undergo heart, lung, or heart-lung transplantation, reported separately by organ type.
Measured: Through 24 months after enrollment.
Survival Free From Irreversible Clinical Deterioration
Percentage of enrolled participants alive without protocol-defined irreversible deterioration that precludes the intended advanced-therapy pathway at each prespecified time point.
Measured: At 90 days, 1 year, and 2 years after enrollment.
Resolution of Identified Barriers
Percentage of prespecified clinical, administrative, financial, regulatory, logistical, geographic, social, technological, or information barriers documented as resolved according to the barrier-specific rule; each barrier is the unit of analysis.
Measured: Within 180 days after identification of each barrier.
Authorized Enrollment in an External Advanced-Therapy Protocol
Percentage of enrolled participants who provide protocol-specific consent and are formally enrolled in an independently governed advanced-therapy protocol. Referral, contact, screening, or APD-G alone is not enrollment. This outcome measures access and not efficacy or safety of the external product.
Measured: 24 months after enrollment.
Utilization of TORCH-Evaluated Donor Organs
Percentage of donor organs meeting the prespecified evaluable-opportunity denominator that are implanted. Final disposition is classified as implanted, recovered but not implanted, or not recovered, with prespecified reasons for non-use recorded.
Measured: At final disposition of each donor organ, during the perioperative/periprocedural period, including implantation, recovery without implantation, or documented non-use.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2026
- Study start30 Mar 2027 (estimated)
- Primary completion30 Mar 2029 (estimated)
- Study completion30 Mar 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Heart DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CardioVision International Tech, S.A.S. de C.V.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Advanced Science Technologies
- Responsible party
- Sponsor
- Investigators
- Eliecer Villamizar De La Hoz, MD, Principal investigator, CardioVision International Tech S.A. de C.V.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07837024
- Sponsor's protocol ID
- TORCH-LATAM-003
- Acronym
- TORCH-003
- Status last verified
- Sep 2026
- First submitted
- 8 Sep 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Stepped-Wedge Cluster Randomized Trial of the TORCH Congenital Advanced Therapies Pathway for Children and Adults With Congenital Heart Disease in Latin America
- ClinicalTrials.gov ID
- NCT07837024
- Acronym / sponsor ID
- TORCH-003 / TORCH-LATAM-003
- 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
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- CardioVision International Tech, S.A.S. de C.V.Industry (pharma, biotech, devices)
- Collaborators
- Advanced Science Technologies
- Study start
- 30 Mar 2027 (estimated)
- Primary completion
- 30 Mar 2029 (estimated)
- Study completion
- 30 Mar 2031 (estimated)
- First posted
- 23 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Each TORCH regional network cluster is anchored in an authorized advanced-therapy or transplant center and may include activated evaluation, referral, congenital cardiology, pulmonary hypertension, intensive-care, mechanical-support, donor-origin, procurement, preservation, logistics, and data-coordination nodes. Children and adults with congenital heart disease may be identified at transplanting or non-transplanting centers when an authorized route to specialized evaluation exists. Authorized centers and competent authorities retain all legal and clinical authority for candidacy, waiting-list activation, organ acceptance, allocation, and transplantation.
The recipient pathway records identification, referral, enrollment, completion of multidisciplinary congenital evaluation, a documented advanced-pathway decision, barrier management, activation of an authorized pathway or official waiting list, longitudinal clinical and support status, transplantation, regulated external-protocol enrollment, or an alternative outcome. Study enrollment is analytically distinct from advanced-therapy candidacy and official wait-list status.
The pathway permits clinically documented redirection among heart, lung, heart-lung, or other authorized transplant evaluation; temporary or durable mechanical support; recovery; surveillance; palliative care; and independently governed investigational protocols. TORCH does not assign an investigational therapy, device, cell, organoid, or xenograft and does not infer efficacy or safety for such products.
Where legally authorized, donor-organ and recipient pathways converge at traceable compatibility and offer episodes. Each decision, non-acceptance reason, reassignment, urgency change, distance, logistics constraint, and final disposition is time-stamped. TORCH does not create a supranational allocation authority or override governmental or institutional systems.
Interoperability may range from audited manual transfer to structured documents, batch exchange, application programming interfaces, standards-based exchange, or validated remote-monitoring devices. Cross-border activity is activated only after applicable ethical, regulatory, institutional, data-protection, financial, and operational approvals.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| TORCH-CATP Intervention Period | Experimental | Other: TORCH Congenital Advanced Therapies Pathway (TORCH-CATP)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. |
| 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. |
Who may qualify
- Ages
- 0 days and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TORCH Congenital Advanced Therapies Pathway (TORCH-CATP)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. | Other | TORCH-CATP Intervention Period |
Primary outcome
Completion of Multidisciplinary Congenital Advanced-Therapy Evaluation and Documented Pathway Decision Within 90 Days
Time frame: Within 90 days after enrollment.
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.
11 secondary outcomes
Activation of an Authorized Advanced-Therapy Pathway or Official Waiting List
Time frame: Within 180 days after the first documented advanced-pathway decision qualifying for activation.
Time to Completed Multidisciplinary Evaluation and Advanced-Pathway Decision
Time frame: From enrollment to completed evaluation and documented advanced-pathway decision, assessed through 180 days.
Redirection of the Advanced-Therapy Pathway
Time frame: Through 24 months after enrollment.
Waiting-List Status or Urgency Transition
Time frame: At each documented waiting-list transition through 24 months after enrollment.
Initiation of Temporary Mechanical Circulatory or Extracorporeal Life Support
Time frame: Through 24 months after enrollment.
Durable Mechanical Support Implantation
Time frame: Through 24 months after enrollment.
Transplantation by Organ Type
Time frame: Through 24 months after enrollment.
Survival Free From Irreversible Clinical Deterioration
Time frame: At 90 days, 1 year, and 2 years after enrollment.
Resolution of Identified Barriers
Time frame: Within 180 days after identification of each barrier.
Authorized Enrollment in an External Advanced-Therapy Protocol
Time frame: 24 months after enrollment.
Utilization of TORCH-Evaluated Donor Organs
Time frame: At final disposition of each donor organ, during the perioperative/periprocedural period, including implantation, recovery without implantation, or documented non-use.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- TORCH-LATAM Institutional Study WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Eliecer Villamizar De La Hoz, MD principal investigator
CardioVision International Tech S.A. de C.V.
Questions about this trial
What is this clinical trial studying?
A study testing TORCH Congenital Advanced Therapies Pathway (TORCH-CATP) in people with Congenital Heart Disease and Advanced Heart Failure, run by CardioVision International Tech, S.A.S. de C.V..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eliecer Villamizar De La Hoz, MD (+50370878226, info@torch-latam.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Completion of Multidisciplinary Congenital Advanced-Therapy Evaluation and Documented Pathway Decision Within 90 Days (time frame: Within 90 days after enrollment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.