TORCH-LATAM-002: Regional Pathway for Adult Heart Transplant Evaluation and Candidacy (TORCH-002)
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.
Aperçu de l'étude
Statut
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Eliecer Villamizar De La Hoz, MD
- Numéro de téléphone: +50370876226
- E-mail: info@torch-latam.org
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La 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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Recherche sur les services de santé
- Répartition: Randomisé
- Modèle interventionnel: Affectation séquentielle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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. |
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. |
|
Aucune 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. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Completion of Multidisciplinary Advanced Heart Failure Evaluation and Documented Transplant Candidacy Decision Within 90 Days
Délai: 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.
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Activation of an Authorized Pathway or Official Waiting List
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: Through 24 months after enrollment.
|
Percentage of enrolled participants who undergo heart transplantation. |
Through 24 months after enrollment.
|
|
Death or Irreversible Clinical Deterioration
Délai: 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
Délai: 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
Délai: 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.
|
Collaborateurs et enquêteurs
Collaborateurs
Les enquêteurs
- Chercheur principal: Eliecer Villamizar De La Hoz, MD, CardioVision International Tech S.A. de C.V.
Publications et liens utiles
Liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Autres numéros d'identification d'étude
- TORCH-LATAM-002
Plan pour les données individuelles des participants (IPD)
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Informations sur les médicaments et les dispositifs, documents d'étude
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