TORCH-LATAM-002: Regional Pathway for Adult Heart Transplant Evaluation and Candidacy (TORCH-002)

October 7, 2026 updated by: CardioVision International Tech, S.A.S. de C.V.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
360

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: TORCH Integrated Pathway Period

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

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.
No Intervention: Usual Local Pathway Period

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 the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Within 90 days after enrollment.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.

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.
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.

Time from enrollment to completion of the prespecified multidisciplinary evaluation and documentation of a transplant-candidacy decision.
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.

Number and percentage of participants with prespecified clinical, administrative, financial, regulatory, logistical, geographic, social, technological, or data-exchange barriers. Multiple categories may be recorded.
Through 90 days after enrollment.
Resolution of Identified Barriers
Time Frame: Within 180 days after identification of each barrier.

Percentage of prespecified barriers documented as resolved, with resolution defined by the barrier-specific rule.
Within 180 days after identification of each barrier.
Heart Transplantation
Time Frame: Through 24 months after enrollment.

Percentage of enrolled participants who undergo heart transplantation.
Through 24 months after enrollment.
Death or Irreversible Clinical Deterioration
Time Frame: Through 24 months after enrollment.

Percentage of enrolled participants who die or develop protocol-defined irreversible deterioration that precludes the intended transplant pathway.
Through 24 months after enrollment.
Durable Mechanical Circulatory Support Implantation
Time Frame: 24 months after enrollment.

Percentage of enrolled participants receiving durable mechanical circulatory support. Temporary extracorporeal membrane oxygenation or other temporary support is not counted.
24 months after enrollment.
Utilization of TORCH-Evaluated Donor Organs
Time Frame: Perioperative/periprocedural period; at final disposition of each donor organ.

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.
Perioperative/periprocedural period; at final disposition of each donor organ.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
CardioVision International Tech, S.A.S. de C.V.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Advanced Science Technologies

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Eliecer Villamizar De La Hoz, MD, CardioVision International Tech S.A. de C.V.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 30, 2027

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 30, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 30, 2031

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 8, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 17, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 23, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 13, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 7, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TORCH-LATAM-002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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