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
- 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 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
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 Adult Heart Transplant Evaluation and Candidacy Pathway for Adults With Advanced Heart Failure in Latin America
- ClinicalTrials.gov ID
- NCT07836803
- Acronym / sponsor ID
- TORCH-002 / TORCH-LATAM-002
- Keywords
- advanced heart failure, adult heart transplantation, transplant candidacy, referral pathway, waiting list, donor organ, organ utilization, implementation science
- 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-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.
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.
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 adult heart transplant evaluation and candidacy pathway. Repeated cross-sectional cohorts are enrolled in each cluster-period.
| Arm | Type | Receives |
|---|---|---|
| TORCH Integrated Pathway Period | Experimental | Other: TORCH Adult Heart Transplant Evaluation and Candidacy PathwayParticipants 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
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 Adult Heart Transplant Evaluation and Candidacy PathwayA 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. | Other | TORCH Integrated Pathway Period |
Primary outcome
Completion of Multidisciplinary Advanced Heart Failure Evaluation and Documented Transplant Candidacy Decision Within 90 Days
Time frame: Within 90 days after enrollment.
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.
8 secondary outcomes
Activation of an Authorized Pathway or Official Waiting List
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 frame: From enrollment to completed evaluation and documented candidacy decision, assessed through 180 days.
Participant-Level Barriers to Evaluation and Pathway Activation
Time frame: Through 90 days after enrollment.
Resolution of Identified Barriers
Time frame: Within 180 days after identification of each barrier.
Heart Transplantation
Time frame: Through 24 months after enrollment.
Death or Irreversible Clinical Deterioration
Time frame: Through 24 months after enrollment.
Durable Mechanical Circulatory Support Implantation
Time frame: 24 months after enrollment.
Utilization of TORCH-Evaluated Donor Organs
Time frame: Perioperative/periprocedural period; at final disposition of each donor organ.
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 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..
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 (+50370876226, 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 Advanced Heart Failure Evaluation and Documented Transplant Candidacy 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.