An interventional study of TORCH Congenital Advanced Therapies Pathway (TORCH-CATP) in Congenital Heart Disease, Advanced Heart Failure and Respiratory Failure, 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
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.
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.
991 studies on the registry are indexed under Heart Defects, Congenital; 251 are open to participants now.
This study's planned enrollment of 360 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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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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.
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.
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)
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.
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.
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.
Time frame: Within 90 days after enrollment.
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.
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 from enrollment to completion of the prespecified multidisciplinary evaluation and documentation of a valid 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
Percentage of enrolled participants with a documented change in intended advanced therapy or destination pathway, with origin, destination, authority, and reason recorded.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: At final disposition of each donor organ, during the perioperative/periprocedural period, including implantation, recovery without implantation, or documented non-use.
No study locations are listed for this record.
Plan to share: Undecided
Start is estimated for Mar 2027; primary completion for Mar 2029, 24 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 24 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 Sep 2026. You cannot join it, but the record below documents what was studied.
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