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

NCT07826078 | Not Yet Recruiting

• 1 other identifier: TORCH-LATAM-004
• Study Type: interventional
• Target: 360
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Advanced Heart Failure; Acquired Heart Disease; Structural Heart Disease; Heart Transplantation; Mechanical Circulatory Support

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (12)

• Activation of an Authorized Advanced-Therapy Pathway or Official Waiting List

  Within 180 days after the first documented advanced-pathway decision qualifying for activation.

• Time to Completed Multidisciplinary Evaluation and Advanced-Pathway Decision

  From enrollment to completed evaluation and documented advanced-pathway decision, assessed through 180 days.

• Redirection of the Advanced-Therapy Pathway

  Through 24 months after enrollment.

• Waiting-List Status or Urgency Transition

  At each documented waiting-list transition through 24 months after enrollment.

• Initiation of Temporary Mechanical Circulatory or Extracorporeal Life Support

  Through 24 months after enrollment.

Study Arms (2)

TORCH-AATP Intervention Period

EXPERIMENTAL

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)

Usual Local Pathway Period

NO INTERVENTION

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.

Interventions

TORCH Adult Advanced Therapies Pathway (TORCH-AATP) OTHER

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.

TORCH-AATP Intervention Period

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

+50370878226; 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 advanced-therapies pathway. Repeated cross-sectional cohorts are enrolled in each cluster-period.

Study Record Dates

• First Submitted: September 8, 2026
• First Posted: September 17, 2026
• Study Start (Estimated): March 30, 2027
• Primary Completion (Estimated): March 30, 2029
• Study Completion (Estimated): March 30, 2031
• Last Updated: September 17, 2026

Record last verified: 2026-09