Acquired Heart Disease, Advanced Heart Failure, Heart Transplantation, Mechanical Circulatory Support, Structural Heart Disease
Conditions
Keywords
advanced heart failure, acquired heart disease, structural heart disease, transplant candidacy, waiting list, mechanical circulatory support, ECMO, advanced structural intervention, advanced therapies, implementation science, health services research, Latin America
Brief summary
TORCH-LATAM-004 is a pragmatic stepped-wedge cluster randomized trial evaluating a regional pathway for adults with advanced heart failure secondary to acquired or structural heart disease who may require heart or combined transplantation, mechanical circulatory or extracorporeal support, advanced structural intervention, or another regulated advanced-therapy pathway. Clusters transition from usual local pathways to TORCH-AATP. The primary outcome is completion of the prespecified multidisciplinary evaluation and documentation of an advanced-pathway decision within 90 days after enrollment. The study also evaluates barriers, authorized pathway or waiting-list activation, longitudinal status, mechanical support, definitive therapy, external regulated pathways, and clinical outcomes. Donor-organ and matching events are captured only where legally authorized and do not replace national allocation systems or transplant-center decisions.
Detailed description
Each TORCH regional network cluster is anchored in an authorized advanced-therapy or transplant center and may include activated evaluation, referral, advanced-heart-failure, structural-heart, intensive-care, mechanical-support, donor-origin, procurement, preservation, logistics, and data-coordination nodes. Adults with advanced heart failure secondary to acquired or structural heart disease may be identified at transplanting or non-transplanting centers when an authorized route to specialized evaluation exists. Authorized centers and competent authorities retain all legal and clinical authority for advanced-therapy candidacy, waiting-list activation, organ acceptance, allocation, and transplantation. The recipient pathway records identification, referral, enrollment, completion of multidisciplinary adult evaluation, a documented advanced-pathway decision, barrier management, activation of an authorized pathway or official waiting list, longitudinal clinical and support status, transplantation, advanced structural intervention, regulated external-protocol enrollment, or an alternative outcome. Study enrollment is analytically distinct from advanced-therapy candidacy and official wait-list status. The pathway permits clinically documented redirection among heart or combined transplantation; temporary or durable mechanical support; advanced structural intervention; recovery; surveillance; palliative care; and independently governed investigational protocols. TORCH does not assign an investigational drug, device, cell, organoid, xenograft, or other experimental therapy and does not infer efficacy or safety for such products. Where legally authorized, donor-organ and recipient pathways converge at traceable compatibility and offer episodes. Each decision, non-acceptance reason, reassignment, urgency change, distance, logistics constraint, and final disposition is time-stamped. TORCH does not create a supranational allocation authority or 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. Cross-border activity is activated only after applicable ethical, regulatory, institutional, data-protection, financial, and operational approvals.
Interventions
OTHERTORCH Adult Advanced Therapies Pathway (TORCH-AATP)
A multicomponent health-services pathway that standardizes identification, referral, multidisciplinary adult advanced-heart-failure evaluation, advanced-pathway decision documentation, barrier navigation, longitudinal waiting-list and support status, authorized donor-organ and matching traceability, and secure information exchange. It does not assign organs, authorize therapies, or replace transplant-center or governmental decisions.
Sponsors
CardioVision International Tech, S.A.S. de C.V.
Advanced Sciences Technologies, S.A. de C.V.
Advanced Science Technologies S.A.S.
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention model description
Clusters are randomized to the sequence in which they transition from usual local pathways to the TORCH adult advanced-therapies pathway. Repeated cross-sectional cohorts are enrolled in each cluster-period.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult aged 18 years or older at informed consent. * Documented acquired or structural heart disease with advanced heart failure meeting a protocol-defined trigger for specialized advanced-therapy evaluation. * Identification within an activated TORCH network cluster with an operational route to at least one authorized advanced-therapy or transplant center. * Ability to complete protocol-defined follow-up directly or through an authorized network pathway. * Provision of informed consent according to applicable requirements.
Exclusion criteria
* Congenital heart disease as the primary condition, or absence of a documented pathophysiological relationship between acquired or structural heart disease and advanced heart failure. * 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 advanced-pathway decision were already completed and remain clinically current before enrollment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Completion of Multidisciplinary Adult Advanced-Therapy Evaluation and Documented Pathway Decision Within 90 Days | Within 90 days after enrollment. | Percentage of eligible enrolled participants who complete the prespecified multidisciplinary adult advanced-therapy evaluation and have a documented advanced-pathway decision within 90 days after enrollment. APD-A, APD-B, APD-D, APD-E, APD-F, APD-G, and APD-H count as completed decisions when the minimum evaluation is complete. APD-C denotes incomplete evaluation and is not counted as success. Death, irreversible deterioration, or missing evidence before day 90 is not counted as success unless the minimum evaluation and a valid decision were documented. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Activation of an Authorized Advanced-Therapy Pathway or Official Waiting List | Within 180 days after the first documented advanced-pathway decision qualifying for activation. | Percentage of participants with a qualifying advanced-pathway decision who achieve documented activation of an authorized pathway or official waiting list. Enrollment alone is not activation. |
| Time to Completed Multidisciplinary Evaluation and Advanced-Pathway Decision | From enrollment to completed evaluation and documented advanced-pathway decision, assessed through 180 days. | Time from enrollment to completion of the prespecified multidisciplinary adult evaluation and documentation of a valid advanced-pathway decision. |
| Redirection of the Advanced-Therapy Pathway | Through 24 months after enrollment. | Percentage of enrolled participants with a documented change in intended advanced therapy or destination pathway, with origin, destination, authority, and reason recorded. |
| Waiting-List Status or Urgency Transition | At each documented waiting-list transition through 24 months after enrollment. | Number and distribution of documented waiting-list status or urgency transitions by reason among participants with an official waiting-list episode. |
| Initiation of Temporary Mechanical Circulatory or Extracorporeal Life Support | Through 24 months after enrollment. | Percentage of enrolled participants with initiation of protocol-defined temporary mechanical circulatory support or extracorporeal life support; organ supported, configuration, and therapeutic intent are classified. |
| Durable Mechanical Support Implantation | Through 24 months after enrollment. | Percentage of enrolled participants receiving protocol-defined durable mechanical circulatory support; device category and therapeutic strategy are reported separately. |
| Transplantation by Organ Type | Through 24 months after enrollment. | Percentage of enrolled participants who undergo heart or combined transplantation, reported separately by transplant type. |
| Advanced Structural Heart Intervention | Through 24 months after enrollment. | Percentage of enrolled participants who undergo a protocol-defined advanced structural heart intervention as the documented destination therapy. |
| Survival Free From Irreversible Clinical Deterioration | At 90 days, 1 year, and 2 years after enrollment. | Percentage of enrolled participants alive without protocol-defined irreversible deterioration that precludes the intended advanced-therapy pathway at each prespecified time point. |
| Resolution of Identified Barriers | Within 180 days after identification of each barrier. | Percentage of prespecified clinical, administrative, financial, regulatory, logistical, geographic, social, technological, or information barriers documented as resolved according to the barrier-specific rule; each barrier is the unit of analysis. |
| Authorized Enrollment in an External Advanced-Therapy Protocol | Through 24 months after enrollment. | Percentage of enrolled participants who provide protocol-specific consent and are formally enrolled in an independently governed advanced-therapy protocol. Referral, contact, screening, or APD-G alone is not enrollment. This outcome measures access and not efficacy or safety of the external product. |
| Utilization of TORCH-Evaluated Donor Organs | Up to 24 months after participant enrollment. | Percentage of donor organs meeting the prespecified evaluable-opportunity denominator that are implanted. Final disposition is classified as implanted, recovered but not implanted, or not recovered, with prespecified reasons for non-use recorded. |
Contacts
CONTACTEliecer Villamizar De La Hoz, MD
PRINCIPAL_INVESTIGATOREliecer Villamizar De La Hoz, MD
CardioVision International Tech S.A. de C.V.
Outcome results
None listed