Advanced Heart FailureTORCH-002NCT07836803
TORCH-LATAM-002: Regional Pathway for Adult Heart Transplant Evaluation and Candidacy
A study testing TORCH Adult Heart Transplant Evaluation and Candidacy Pathway in people with Advanced Heart Failure and Heart Transplantation, run by CardioVision International Tech, S.A.S. de C.V..
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Heart Failure, Heart Transplantation, Acquired Heart Disease
- What is being tested?
- TORCH Adult Heart Transplant Evaluation and Candidacy Pathway
- 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
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or older.
- Advanced heart failure or acquired or structural heart disease meeting a protocol-defined trigger for specialized heart transplant evaluation.
- Identification within an activated TORCH network cluster with an operational route to at least one authorized transplant center.
- Ability to complete the protocol-defined follow-up directly or through an authorized network pathway.
- Provision of informed consent according to applicable requirements.
Who cannot join
- Primary congenital heart disease managed under the pediatric or congenital TORCH protocol.
- No authorized route for protocol evaluation or follow-up at the time of enrollment.
- Unable or unwilling to provide informed consent when required.
- The prespecified multidisciplinary evaluation and transplant-candidacy decision were already completed before the enrollment reference time.
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 Adult Heart Transplant Evaluation and Candidacy Pathway for Adults With Advanced Heart Failure in Latin America
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.
Read the detailed description
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.
- Being tested
- TORCH Adult Heart Transplant Evaluation and Candidacy Pathway
- Keywords
- advanced heart failure, adult heart transplantation, transplant candidacy, referral pathway, waiting list, donor organ, organ utilization, implementation science, health services research, Latin America, interoperability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TORCH Adult Heart Transplant Evaluation and Candidacy PathwayOther
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.
| Study group | Role | What they receive |
|---|---|---|
| TORCH Integrated Pathway Period | Experimental | 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. Receives: Other: TORCH Adult Heart Transplant Evaluation and Candidacy Pathway |
| Usual Local Pathway Period | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within 90 days after enrollment.
Secondary outcomes (8)
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.
Measured: 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.
Measured: 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.
Measured: Through 90 days after enrollment.
Resolution of Identified Barriers
Percentage of prespecified barriers documented as resolved, with resolution defined by the barrier-specific rule.
Measured: Within 180 days after identification of each barrier.
Heart Transplantation
Percentage of enrolled participants who undergo heart transplantation.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Perioperative/periprocedural period; at final disposition of each donor organ.
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 Advanced Heart FailureStudies 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 adult heart transplant evaluation and candidacy 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
- NCT07836803
- Sponsor's protocol ID
- TORCH-LATAM-002
- Acronym
- TORCH-002
- 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