TORCH-LATAM-004: Regional Advanced-Therapy Pathways for Adults With Acquired or Structural Heart Disease (TORCH-004)

A Stepped-Wedge Cluster Randomized Trial of the TORCH Adult Advanced Therapies Pathway for Adults With Advanced Heart Failure Secondary to Acquired or Structural Heart Disease in Latin America

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Acquired Heart Disease; Heart Transplantation; Structural Heart Disease; Advanced Heart Failure; Mechanical Circulatory Support
• Intervention / Treatment: Other: TORCH Adult Advanced Therapies Pathway (TORCH-AATP)

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.

• Study Type: Interventional
• Enrollment (Estimated): 360
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Eliecer Villamizar De La Hoz, MD; Phone Number: +50370878226; Email: eliecerevillamizar@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TORCH-AATP Intervention Period; Participants enrolled while their cluster is assigned to the intervention period receive the TORCH Adult Advanced Therapies Pathway, including protocolized identification and referral, multidisciplinary evaluation, pathway-decision adjudication, barrier navigation, pathway and waiting-list status tracking, and traceable donor-organ opportunity coordination when applicable.	Other: TORCH 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.
No Intervention: Usual Local Pathway Period; Participants enrolled before their cluster transitions to TORCH-AATP receive locally available referral, evaluation, treatment, support, structural-heart, and transplant-candidacy processes. Study data collection does not alter the authority of local programs or competent authorities.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Completion of Multidisciplinary Adult Advanced-Therapy Evaluation and Documented Pathway Decision Within 90 Days	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.	Within 90 days after enrollment.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Activation of an Authorized Advanced-Therapy Pathway or Official Waiting List	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.	Within 180 days after the first documented advanced-pathway decision qualifying for activation.
Time to Completed Multidisciplinary Evaluation and Advanced-Pathway Decision	Time from enrollment to completion of the prespecified multidisciplinary adult evaluation and documentation of a valid advanced-pathway decision.	From enrollment to completed evaluation and documented advanced-pathway decision, assessed through 180 days.
Redirection of the Advanced-Therapy Pathway	Percentage of enrolled participants with a documented change in intended advanced therapy or destination pathway, with origin, destination, authority, and reason recorded.	Through 24 months after enrollment.
Waiting-List Status or Urgency Transition	Number and distribution of documented waiting-list status or urgency transitions by reason among participants with an official waiting-list episode.	At each documented waiting-list transition through 24 months after enrollment.
Initiation of Temporary Mechanical Circulatory or Extracorporeal Life Support	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.	Through 24 months after enrollment.
Durable Mechanical Support Implantation	Percentage of enrolled participants receiving protocol-defined durable mechanical circulatory support; device category and therapeutic strategy are reported separately.	Through 24 months after enrollment.
Transplantation by Organ Type	Percentage of enrolled participants who undergo heart or combined transplantation, reported separately by transplant type.	Through 24 months after enrollment.
Advanced Structural Heart Intervention	Percentage of enrolled participants who undergo a protocol-defined advanced structural heart intervention as the documented destination therapy.	Through 24 months after enrollment.
Survival Free From Irreversible Clinical Deterioration	Percentage of enrolled participants alive without protocol-defined irreversible deterioration that precludes the intended advanced-therapy pathway at each prespecified time point.	At 90 days, 1 year, and 2 years after enrollment.
Resolution of Identified Barriers	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.	Within 180 days after identification of each barrier.
Authorized Enrollment in an External Advanced-Therapy Protocol	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.	Through 24 months after enrollment.
Utilization of TORCH-Evaluated Donor Organs	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.	Up to 24 months after participant enrollment.

Collaborators and Investigators

• Sponsor: CardioVision International Tech, S.A.S. de C.V.
• Collaborators: Advanced Sciences Technologies, S.A. de C.V.; Advanced Science Technologies S.A.S.
• Investigators: Principal Investigator: Eliecer Villamizar De La Hoz, MD, CardioVision International Tech S.A. de C.V.

Study record dates

Study Major Dates

• Study Start (Estimated): March 30, 2027
• Primary Completion (Estimated): March 30, 2029
• Study Completion (Estimated): March 30, 2031

Study Registration Dates

• First Submitted: September 8, 2026
• First Submitted That Met QC Criteria: September 11, 2026
• First Posted (Actual): September 17, 2026

Study Record Updates

• Last Update Posted (Actual): September 17, 2026
• Last Update Submitted That Met QC Criteria: September 11, 2026
• Last Verified: September 1, 2026

More Information

Terms related to this study

• Keywords: ECMO; implementation science; health services research; mechanical circulatory support; Latin America; waiting list; advanced heart failure; structural heart disease; acquired heart disease; transplant candidacy; advanced structural intervention; advanced therapies
• Other Study ID Numbers: TORCH-LATAM-004

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