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

NCT07836803 | Not Yet Recruiting

• 1 other identifier: TORCH-LATAM-002
• Study Type: interventional
• Target: 360
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Advanced Heart Failure; Heart Transplantation; Acquired Heart Disease

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

Outcome Measures

Primary Outcomes (1)

• 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.

  Within 90 days after enrollment.

Secondary Outcomes (8)

• Activation of an Authorized Pathway or Official Waiting List

  Within 180 days after the first documented transplant-candidacy decision qualifying for pathway or waitlist activation.

• Time to Completed Evaluation and Candidacy Decision

  From enrollment to completed evaluation and documented candidacy decision, assessed through 180 days.

• Participant-Level Barriers to Evaluation and Pathway Activation

  Through 90 days after enrollment.

• Resolution of Identified Barriers

  Within 180 days after identification of each barrier.

• Heart Transplantation

  Through 24 months after enrollment.

Study Arms (2)

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.

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.

Interventions

TORCH Adult Heart Transplant Evaluation and Candidacy Pathway OTHER

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.

TORCH Integrated Pathway Period

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• CardioVision International Tech, S.A.S. de C.V.: lead
• Advanced Science Technologies S.A.S.: collaborator
• Advanced Sciences Technologies, S.A. de C.V.: collaborator

Study Officials

• Eliecer Villamizar De La Hoz, MD

  CardioVision International Tech S.A. de C.V.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eliecer Villamizar De La Hoz, MD

CONTACT

+50370876226; eliecerevillamizar@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 8, 2026
• First Posted: September 23, 2026
• Study Start (Estimated): March 30, 2027
• Primary Completion (Estimated): March 30, 2029
• Study Completion (Estimated): March 30, 2031
• Last Updated: September 23, 2026

Record last verified: 2026-09