An interventional study of TORCH Adult Heart Transplant Evaluation and Candidacy Pathway in Advanced Heart Failure, Heart Transplantation and Acquired Heart Disease, sponsored by CardioVision International Tech, S.A.S. de C.V.. Not yet recruiting. Open to participants aged 18 Years 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-002 is a pragmatic stepped-wedge cluster randomized trial evaluating an integrated regional pathway for adults with advanced heart failure who require specialized heart transplant evaluation and a documented candidacy decision. Participating network clusters transition from usual local pathways to the TORCH Adult Heart Transplant Evaluation and Candidacy Pathway. The primary outcome is completion of multidisciplinary evaluation and a documented transplant-candidacy decision within 90 days after enrollment. The study also examines pathway activation, barriers, clinical outcomes, waiting-list trajectories, and traceable donor-organ opportunities. Enrollment does not constitute placement on an official waiting list, organ allocation, or authorization of cross-border care.
Each TORCH regional network cluster is anchored in an authorized transplant center and may include activated evaluation, referral, identification, donor-origin, procurement, preservation, logistics, and data-coordination nodes. Adults may be identified at transplanting or non-transplanting centers when an authorized route to specialized evaluation exists. The transplant center 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 evaluation, documented candidacy decision, barrier management, activation of an authorized pathway or official waiting list, clinical change while waiting, donor-recipient opportunity, transplantation, or an alternative outcome. Study enrollment is analytically distinct from transplant candidacy and official wait-list status.
The donor-organ pathway records identification of a possible donor, confirmation of the applicable donation pathway, authorization, organ characterization, activation of an evaluable donor-organ opportunity, compatibility assessment, organ acceptance or rejection, procurement, preservation, transport, implantation, and final disposition. Donation after brain death and donation after circulatory determination of death are represented as distinct branches; normothermic regional perfusion is recorded only when applicable.
The two pathways converge at a traceable donor-organ-recipient matching episode. A characterized organ may be assessed for more than one compatible recipient, and each offer, decision, reason for non-acceptance, reassignment, urgency change, distance, logistics constraint, and final disposition is time-stamped. TORCH does not create a supranational allocation authority and does not 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. Lack of an automated interface does not by itself exclude a site or participant when an authorized, secure, timely, and auditable fallback is available. Cross-border activity is activated only after applicable ethical, regulatory, institutional, data-protection, financial, and operational approvals.
6,331 studies on the registry are indexed under Heart Failure; 1,396 are open to participants now.
This study's planned enrollment of 360 is above the median of 76 across 4,049 interventional studies indexed under Heart Failure.
Browse Heart Failure 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.
Counted across the registry records on this site, refreshed daily.
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 Adult Heart Transplant Evaluation and Candidacy Pathway, including protocolized identification and referral, multidisciplinary evaluation, candidacy adjudication, barrier navigation, pathway and wait-list status tracking, and traceable donor-organ opportunity coordination when applicable.
Other: TORCH Adult Heart Transplant Evaluation and Candidacy Pathway
Participants enrolled before their cluster transitions to the TORCH pathway receive the locally available referral, evaluation, treatment, and transplant-candidacy processes. Study data collection does not alter the legal authority of local transplant programs or competent authorities.
A multicomponent health-services pathway that standardizes identification, referral, multidisciplinary evaluation, candidacy documentation, barrier navigation, longitudinal wait-list status, donor-organ opportunity traceability, and authorized information exchange across activated network nodes. The pathway supports but does not replace institutional or governmental clinical, listing, allocation, or regulatory decisions.
Completion of Multidisciplinary Advanced Heart Failure Evaluation and Documented Transplant Candidacy Decision Within 90 Days
Percentage of eligible enrolled participants who complete the prespecified multidisciplinary advanced heart failure evaluation and have a documented transplant-candidacy decision within 90 days after enrollment. A completed decision includes candidate for pathway or wait-list activation, conditional candidate with modifiable risk, not a candidate for isolated heart transplantation, too stable or transplant not currently indicated, or an alternative therapeutic pathway. An incomplete evaluation is not counted as success.
Time frame: Within 90 days after enrollment.
Activation of an Authorized Pathway or Official Waiting List
Percentage of participants with a candidacy decision qualifying for activation who achieve documented activation of an authorized treatment pathway or official waiting list. Enrollment and candidacy do not themselves constitute listing.
Time frame: Within 180 days after the first documented transplant-candidacy decision qualifying for pathway or waitlist activation.
Time to Completed Evaluation and Candidacy Decision
Time from enrollment to completion of the prespecified multidisciplinary evaluation and documentation of a transplant-candidacy decision.
Time frame: From enrollment to completed evaluation and documented candidacy decision, assessed through 180 days.
Participant-Level Barriers to Evaluation and Pathway Activation
Number and percentage of participants with prespecified clinical, administrative, financial, regulatory, logistical, geographic, social, technological, or data-exchange barriers. Multiple categories may be recorded.
Time frame: Through 90 days after enrollment.
Resolution of Identified Barriers
Percentage of prespecified barriers documented as resolved, with resolution defined by the barrier-specific rule.
Time frame: Within 180 days after identification of each barrier.
Heart Transplantation
Percentage of enrolled participants who undergo heart transplantation.
Time frame: Through 24 months after enrollment.
Death or Irreversible Clinical Deterioration
Percentage of enrolled participants who die or develop protocol-defined irreversible deterioration that precludes the intended transplant pathway.
Time frame: Through 24 months after enrollment.
Durable Mechanical Circulatory Support Implantation
Percentage of enrolled participants receiving durable mechanical circulatory support. Temporary extracorporeal membrane oxygenation or other temporary support is not counted.
Time frame: 24 months after enrollment.
Utilization of TORCH-Evaluated Donor Organs
Percentage of donor organs meeting the prespecified TORCH donor-organ opportunity denominator that are implanted. Final disposition is classified as implanted, recovered but not implanted, or not recovered. Prespecified reasons for non-use are recorded.
Time frame: Perioperative/periprocedural period; at final disposition of each donor organ.
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 236 industry-sponsored interventional studies with no phase under Heart Failure, half reached primary completion within 34 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 62. This study's planned 24 months is below that.
Counting every sponsor, half of 1,354 studies reached it within 31 months; a quarter within 16 and three quarters within 52.
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.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
CardioVision International Tech, S.A.S. de C.V. →