NCT07826078
TORCH-LATAM-004: Regional Advanced-Therapy Pathways for Adults With Acquired or Structural Heart Disease
Not Yet Recruiting · Not Applicable · CardioVision International Tech, S.A.S. de C.V. · registry updated 2026-09-17
Inclusion and exclusion lines below are quoted from ClinicalTrials.gov. No match score is shown, because a score needs a person's age, biomarkers, and treatment dates. Confirm the record with the study team.
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.
Inclusion
- 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
- 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.