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TORCH-LATAM-004: Regional Advanced-Therapy Pathways for Adults With Acquired or Structural Heart Disease
Sponsor: CardioVision International Tech, S.A.S. de C.V.
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
360
Start Date
2027-03-30
Completion Date
2031-03-30
Last Updated
2026-10-13
Healthy Volunteers
No
Conditions
Interventions
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.