[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"CardioVision International Tech, S.A.S. de C.V.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":126},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,59,83,105],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":33,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":48,"lastUpdatePostDateStruct":49,"startDateStruct":52,"completionDateStruct":54,"leadSponsor":56,"locationsCount":4},"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":20,"type":21},360,"ESTIMATED","INTERVENTIONAL",[24],"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.",[27,28,29,30,31,32],"Congenital Heart Disease","Advanced Heart Failure","Respiratory Failure","Heart Transplantation","Lung Transplantation","Heart-Lung Transplantation",[34,35,36,37,38,39,40,41,42,43,44,45,46],"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":50,"type":51},"2026-10-13","ACTUAL",{"date":53,"type":21},"2027-03-30",{"date":55,"type":21},"2031-03-30",{"name":57,"class":58},"CardioVision International Tech, S.A.S. de C.V.","INDUSTRY",{"id":60,"slug":61,"hasResults":11,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":65,"eligibilityCriteria":66,"healthyVolunteers":11,"sex":17,"minAge":67,"maxAge":4,"enrollmentInfo":68,"targetDuration":4,"studyType":22,"phases":69,"briefSummary":70,"conditions":71,"keywords":73,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":48,"lastUpdatePostDateStruct":79,"startDateStruct":80,"completionDateStruct":81,"leadSponsor":82,"locationsCount":4},"100657241","torch-latam-002-regional-pathway-for-adult-heart-transplant-evaluation-and-candidacy-100657241","NCT07836803","TORCH-LATAM-002: Regional Pathway for Adult Heart Transplant Evaluation and Candidacy","A Stepped-Wedge Cluster Randomized Trial of the TORCH Adult Heart Transplant Evaluation and Candidacy Pathway for Adults With Advanced Heart Failure in Latin America","TORCH-002","Inclusion Criteria:\n\n* Age 18 years or older.\n* Advanced heart failure or acquired or structural heart disease meeting a protocol-defined trigger for specialized heart transplant evaluation.\n* Identification within an activated TORCH network cluster with an operational route to at least one authorized transplant center.\n* Ability to complete the protocol-defined follow-up directly or through an authorized network pathway.\n* Provision of informed consent according to applicable requirements.\n\nExclusion Criteria:\n\n* Primary congenital heart disease managed under the pediatric or congenital TORCH protocol.\n* No authorized route for protocol evaluation or follow-up at the time of enrollment.\n* Unable or unwilling to provide informed consent when required.\n* The prespecified multidisciplinary evaluation and transplant-candidacy decision were already completed before the enrollment reference time.","18 Years",{"count":20,"type":21},[24],"TORCH-LATAM-002 is a pragmatic stepped-wedge cluster randomized trial evaluating an integrated regional pathway for adults with advanced heart failure who require specialized heart transplant evaluation and a documented candidacy decision. Participating network clusters transition from usual local pathways to the TORCH Adult Heart Transplant Evaluation and Candidacy Pathway. The primary outcome is completion of multidisciplinary evaluation and a documented transplant-candidacy decision within 90 days after enrollment. The study also examines pathway activation, barriers, clinical outcomes, waiting-list trajectories, and traceable donor-organ opportunities. Enrollment does not constitute placement on an official waiting list, organ allocation, or authorization of cross-border care.",[28,30,72],"Acquired Heart Disease",[37,74,39,75,40,76,77,44,45,46,78],"adult heart transplantation","referral pathway","donor organ","organ utilization","interoperability",{"date":50,"type":51},{"date":53,"type":21},{"date":55,"type":21},{"name":57,"class":58},{"id":84,"slug":85,"hasResults":11,"nctId":86,"briefTitle":87,"officialTitle":88,"acronym":89,"eligibilityCriteria":90,"healthyVolunteers":11,"sex":17,"minAge":67,"maxAge":4,"enrollmentInfo":91,"targetDuration":4,"studyType":22,"phases":92,"briefSummary":93,"conditions":94,"keywords":97,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":48,"lastUpdatePostDateStruct":101,"startDateStruct":102,"completionDateStruct":103,"leadSponsor":104,"locationsCount":4},"100656521","torch-latam-004-regional-advanced-therapy-pathways-for-adults-with-acquired-or-structural-heart-disease-100656521","NCT07826078","TORCH-LATAM-004: Regional Advanced-Therapy Pathways for Adults With Acquired or Structural Heart Disease","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-004","Inclusion Criteria:\n\n* Adult aged 18 years or older at informed consent.\n* Documented acquired or structural heart disease with advanced heart failure meeting a 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 according to applicable requirements.\n\nExclusion Criteria:\n\n* Congenital heart disease as the primary condition, or absence of a documented pathophysiological relationship between acquired or structural heart disease and advanced heart failure.\n* No authorized route for protocol evaluation or follow-up at the time of enrollment.\n* Unable or unwilling to provide informed consent when required.\n* The prespecified multidisciplinary evaluation and advanced-pathway decision were already completed and remain clinically current before enrollment.",{"count":20,"type":21},[24],"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.",[28,72,95,30,96],"Structural Heart Disease","Mechanical Circulatory Support",[37,98,99,39,40,41,42,100,43,44,45,46],"acquired heart disease","structural heart disease","advanced structural intervention",{"date":50,"type":51},{"date":53,"type":21},{"date":55,"type":21},{"name":57,"class":58},{"id":106,"slug":107,"hasResults":11,"nctId":108,"briefTitle":109,"officialTitle":110,"acronym":111,"eligibilityCriteria":112,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":113,"targetDuration":4,"studyType":22,"phases":115,"briefSummary":116,"conditions":117,"keywords":118,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":48,"lastUpdatePostDateStruct":120,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":125,"locationsCount":4},"100654460","torch-latam-a-regional-pathway-to-improve-transplant-evaluation-for-congenital-heart-disease-100654460","NCT07799272","TORCH-LATAM: A Regional Pathway to Improve Transplant Evaluation for Congenital Heart Disease","TORCH-LATAM: A Pragmatic Stepped-Wedge Cluster-Randomized Effectiveness-Implementation Trial of an Integrated Regional Pathway for Heart, Lung, and Heart-Lung Transplant Access in Pediatric and Adult Congenital Heart Disease","TORCH-LATAM","Inclusion Criteria:\n\n* Confirmed congenital heart disease.\n* Age from birth with no protocol-defined upper age limit.\n* Advanced cardiac, pulmonary vascular, or cardiopulmonary deterioration meeting contemporary international criteria for transplant referral\u002Fevaluation, or previously documented transplant candidacy by an authorized program.\n* Clinical presentation within the TORCH scope: heart transplantation; heart-lung transplantation; or, in selected congenital heart disease, bilateral lung transplantation with cardiac repair after multidisciplinary adjudication.\n* Availability of the minimum baseline dataset required for standardized multidisciplinary evaluation and risk stratification.\n* Written informed consent from the participant or legally authorized representative, with assent and re-consent as applicable under local requirements.\n* Ability to undergo protocol-defined longitudinal follow-up.\n* For participants referred from a non-transplant site, an operational referral route within the participating network to at least one authorized transplant center must exist. Prior acceptance by that transplant center is not required for trial enrollment; completion of specialist evaluation and the candidacy decision are post-enrollment trial processes\u002Foutcomes.\n\nExclusion Criteria:\n\n* Absence of congenital heart disease or a transplant indication outside the TORCH congenital-heart-disease scope.\n* No protocol-defined indication for transplant referral\u002Fevaluation after standardized review.\n* A contemporary absolute contraindication to all transplant strategies applicable to the participant that is confirmed by multidisciplinary adjudication and is not considered reversible or re-evaluable under the protocol.\n* Inability to obtain required informed consent\u002Fassent or to collect the minimum essential baseline dataset.\n* A legal, regulatory, or safety condition that prohibits participation in research at the enrolling site.",{"count":114,"type":21},600,[24],"Congenital heart disease can progress to advanced cardiac or cardiopulmonary failure requiring heart, heart-lung, or, in selected congenital conditions, bilateral lung transplantation with cardiac repair. Access to transplant evaluation and organ utilization can vary across regions and institutions, and potential candidates who are never referred or evaluated are not represented in conventional waiting-list statistics. TORCH-LATAM is a pragmatic multicenter stepped-wedge cluster-randomized effectiveness-implementation trial evaluating the TORCH Integrated Transplant Access Pathway (TORCH-ITAP) in Latin America. Regional network clusters transition in a randomized sequence from usual care to TORCH-ITAP. The pathway standardizes early identification and referral, a common recipient dataset, multidisciplinary candidacy adjudication, structured donor-organ assessment, immunologic and anatomic-physiologic matching, preservation and transport traceability, and navigation of clinical, regulatory, logistical, and financial barriers. The primary outcome is the proportion of enrolled recipient participants who complete a standardized multidisciplinary transplant evaluation and receive a documented candidacy decision within 90 days. Secondary outcomes include activation of an official transplant pathway or waitlist where applicable, transplantation within 12 months, pretransplant death or irreversible deterioration, donor-organ utilization, post-transplant safety and survival, and implementation outcomes. Recipient participants constitute the ClinicalTrials.gov enrollment; donors, organs, donor-recipient matches, preservation strategies, and transplant episodes are nested analytic units. TORCH-ITAP does not allocate organs and does not supersede national transplant laws, authorized transplant programs, or governmental requirements for cross-border organ movement.",[27],[30,32,31,119],"Health Services Research",{"date":50,"type":51},{"date":122,"type":21},"2027-03",{"date":124,"type":21},"2031-06",{"name":57,"class":58},""]