[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100657350":3},{"organization":4,"outcomesModule":7,"designInfo":56,"detailedDescription":63,"studyPopulation":55,"armGroups":64,"interventions":75,"overallOfficials":81,"centralContacts":86,"locations":55,"responsibleParty":91,"collaborators":93,"id":96,"slug":97,"hasResults":98,"nctId":99,"briefTitle":100,"officialTitle":101,"acronym":102,"eligibilityCriteria":103,"healthyVolunteers":98,"sex":104,"minAge":105,"maxAge":55,"enrollmentInfo":106,"targetDuration":55,"studyType":109,"phases":110,"briefSummary":112,"conditions":113,"keywords":120,"overallStatus":134,"whyStopped":55,"lastUpdateSubmitDate":135,"lastUpdatePostDateStruct":136,"startDateStruct":139,"completionDateStruct":141,"leadSponsor":143,"locationsCount":55},{"fullName":5,"class":6},"CardioVision International Tech, S.A.S. de C.V.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":55},[9],{"measure":10,"description":11,"timeFrame":12},"Completion of Multidisciplinary Congenital Advanced-Therapy Evaluation and Documented Pathway Decision Within 90 Days","Percentage of eligible enrolled participants who complete the prespecified multidisciplinary congenital 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.",[14,18,22,26,30,33,36,39,43,47,51],{"measure":15,"description":16,"timeFrame":17},"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.",{"measure":19,"description":20,"timeFrame":21},"Time to Completed Multidisciplinary Evaluation and Advanced-Pathway Decision","Time from enrollment to completion of the prespecified multidisciplinary evaluation and documentation of a valid advanced-pathway decision.","From enrollment to completed evaluation and documented advanced-pathway decision, assessed through 180 days.",{"measure":23,"description":24,"timeFrame":25},"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.",{"measure":27,"description":28,"timeFrame":29},"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.",{"measure":31,"description":32,"timeFrame":25},"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.",{"measure":34,"description":35,"timeFrame":25},"Durable Mechanical Support Implantation","Percentage of enrolled participants receiving protocol-defined durable mechanical circulatory or respiratory support; device category and therapeutic strategy are reported separately.",{"measure":37,"description":38,"timeFrame":25},"Transplantation by Organ Type","Percentage of enrolled participants who undergo heart, lung, or heart-lung transplantation, reported separately by organ type.",{"measure":40,"description":41,"timeFrame":42},"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.",{"measure":44,"description":45,"timeFrame":46},"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.",{"measure":48,"description":49,"timeFrame":50},"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.","24 months after enrollment.",{"measure":52,"description":53,"timeFrame":54},"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.","At final disposition of each donor organ, during the perioperative\u002Fperiprocedural period, including implantation, recovery without implantation, or documented non-use.",null,{"allocation":57,"interventionModel":58,"interventionModelDescription":59,"primaryPurpose":60,"observationalModel":55,"timePerspective":55,"maskingInfo":61},"RANDOMIZED","SEQUENTIAL","Clusters are randomized to the sequence in which they transition from usual local pathways to the TORCH congenital advanced-therapies pathway. Repeated cross-sectional cohorts are enrolled in each cluster-period.","HEALTH_SERVICES_RESEARCH",{"masking":62,"maskingDescription":55,"whoMasked":55},"NONE","Each TORCH regional network cluster is anchored in an authorized advanced-therapy or transplant center and may include activated evaluation, referral, congenital cardiology, pulmonary hypertension, intensive-care, mechanical-support, donor-origin, procurement, preservation, logistics, and data-coordination nodes. Children and adults with congenital 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 candidacy, waiting-list activation, organ acceptance, allocation, and transplantation.\n\nThe recipient pathway records identification, referral, enrollment, completion of multidisciplinary congenital evaluation, a documented advanced-pathway decision, barrier management, activation of an authorized pathway or official waiting list, longitudinal clinical and support status, transplantation, regulated external-protocol enrollment, or an alternative outcome. Study enrollment is analytically distinct from advanced-therapy candidacy and official wait-list status.\n\nThe pathway permits clinically documented redirection among heart, lung, heart-lung, or other authorized transplant evaluation; temporary or durable mechanical support; recovery; surveillance; palliative care; and independently governed investigational protocols. TORCH does not assign an investigational therapy, device, cell, organoid, or xenograft and does not infer efficacy or safety for such products.\n\nWhere 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.\n\nInteroperability 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.",[65,71],{"label":66,"type":67,"description":68,"interventionNames":69},"TORCH-CATP Intervention Period","EXPERIMENTAL","Participants enrolled while their cluster is assigned to the intervention period receive the TORCH Congenital 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.",[70],"Other: TORCH Congenital Advanced Therapies Pathway (TORCH-CATP)",{"label":72,"type":73,"description":74,"interventionNames":55},"Usual Local Pathway Period","NO_INTERVENTION","Participants enrolled before their cluster transitions to TORCH-CATP receive locally available referral, evaluation, treatment, support, and transplant-candidacy processes. Study data collection does not alter the authority of local programs or competent authorities.",[76],{"type":77,"name":78,"description":79,"armGroupLabels":80,"otherNames":55},"OTHER","TORCH Congenital Advanced Therapies Pathway (TORCH-CATP)","A multicomponent health-services pathway that standardizes identification, referral, multidisciplinary congenital-heart-disease 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.",[66],[82],{"name":83,"affiliation":84,"role":85},"Eliecer Villamizar De La Hoz, MD","CardioVision International Tech S.A. de C.V.","PRINCIPAL_INVESTIGATOR",[87],{"name":83,"role":88,"phone":89,"phoneExt":55,"email":90},"CONTACT","+50370878226","info@torch-latam.org",{"type":92,"investigatorFullName":55,"investigatorTitle":55,"investigatorAffiliation":55,"oldNameTitle":55,"oldOrganization":55},"SPONSOR",[94],{"name":95,"class":6},"Advanced Science Technologies","100657350","torch-latam-003-regional-advanced-therapy-pathways-for-congenital-heart-disease-100657350",false,"NCT07837024","TORCH-LATAM-003: Regional Advanced-Therapy Pathways for Congenital Heart Disease","A Stepped-Wedge Cluster Randomized Trial of the TORCH Congenital Advanced Therapies Pathway for Children and Adults With Congenital Heart Disease in Latin America","TORCH-003","Inclusion Criteria:\n\n* Child or adult of any age with congenital heart disease; enrollment of minors requires parent or legal-representative permission and assent when applicable.\n* Congenital heart disease with advanced cardiac and\u002For respiratory failure, associated pulmonary hypertension, or another protocol-defined trigger for specialized advanced-therapy evaluation.\n* Identification within an activated TORCH network cluster with an operational route to at least one authorized advanced-therapy or transplant center.\n* Ability to complete protocol-defined follow-up directly or through an authorized network pathway.\n* Provision of informed consent by the participant or legally authorized representative, and assent when applicable, according to local requirements.\n\nExclusion Criteria:\n\n* Absence of congenital heart disease as the underlying condition defining the advanced cardiac and\u002For respiratory-failure pathway.\n* No authorized route for protocol evaluation or follow-up at the time of enrollment.\n* Unable or unwilling to provide informed consent or legally authorized permission when required.\n* The prespecified multidisciplinary evaluation and advanced-pathway decision were already completed and remain clinically current before enrollment.","ALL","0 Days",{"count":107,"type":108},360,"ESTIMATED","INTERVENTIONAL",[111],"NA","TORCH-LATAM-003 is a pragmatic stepped-wedge cluster randomized trial evaluating a regional pathway for children and adults with congenital heart disease and advanced cardiac and\u002For respiratory failure who may require heart, lung, or heart-lung transplantation, mechanical circulatory or extracorporeal support, or another regulated advanced-therapy pathway. Clusters transition from usual local pathways to TORCH-CATP. 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, advanced support, definitive therapy, 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.",[114,115,116,117,118,119],"Congenital Heart Disease","Advanced Heart Failure","Respiratory Failure","Heart Transplantation","Lung Transplantation","Heart-Lung Transplantation",[121,122,123,124,125,126,127,128,129,130,131,132,133],"congenital heart disease","pediatric","adult congenital heart disease","advanced heart failure","advanced respiratory failure","transplant candidacy","waiting list","mechanical circulatory support","ECMO","advanced therapies","implementation science","health services research","Latin America","NOT_YET_RECRUITING","2026-10-07",{"date":137,"type":138},"2026-10-13","ACTUAL",{"date":140,"type":108},"2027-03-30",{"date":142,"type":108},"2031-03-30",{"name":5,"class":6}]