TORCH-LATAM-002: Regional Pathway for Adult Heart Transplant Evaluation and Candidacy
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCardioVision International Tech, S.A.S. de C.V.
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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 design
Design model
Sequential
Treatments tested in this trial
TORCH Adult Heart Transplant Evaluation and Candidacy Pathway
Other interventionA 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.
Treatment groups
360 Participants
are divided into 2 treatment groupsGroup A: TORCH Integrated Pathway PeriodExperimental treatment 1 intervention
Group B: Usual Local Pathway PeriodNo intervention 0 interventions
Trial outcomes
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.
Time frame
Within 90 days after enrollment.Secondary outcomes
1
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.2
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.3
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.4
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.Locations
Sponsors and contacts
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CardioVision International Tech, S.A.S. de C.V.
Lead sponsor
Advanced Science Technologies S.A.S.
Collaborator
Advanced Sciences Technologies, S.A. de C.V.
Collaborator
Source ClinicalTrials.gov
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