[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100522242":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":36,"centralContacts":44,"locations":54,"responsibleParty":130,"collaborators":133,"id":139,"slug":140,"hasResults":141,"nctId":142,"briefTitle":143,"officialTitle":144,"acronym":145,"eligibilityCriteria":146,"healthyVolunteers":141,"sex":147,"minAge":148,"maxAge":149,"enrollmentInfo":150,"targetDuration":26,"studyType":153,"phases":154,"briefSummary":156,"conditions":157,"keywords":162,"overallStatus":57,"whyStopped":26,"lastUpdateSubmitDate":171,"lastUpdatePostDateStruct":172,"startDateStruct":175,"completionDateStruct":177,"leadSponsor":179,"locationsCount":180},{"fullName":5,"class":6},"Stanford University","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Cardiohelp device managed according to a standardized guideline using heparin anticoagulation","EXPERIMENTAL","Participants receiving the Cardiohelp device for severe heart failure will be managed according to a standardized treatment guideline (equipment, monitoring, etc.) where heparin is the primary blood thinner to estimate the safety and effectiveness of the device and blood thinner strategy for up to 30 days of support.",[13,14],"Device: Cardiohelp device (VA-ECMO)","Drug: Heparin",{"label":16,"type":10,"description":17,"interventionNames":18},"Cardiohelp device managed according to a standardized guideline using bivalirudin anticoagulation","Participants receiving the Cardiohelp device for severe heart failure will be managed according to a standardized treatment guideline (equipment, monitoring, etc.) where bivalirudin is the primary blood thinner to estimate the safety and effectiveness of the device and blood thinner strategy for up to 30 days of support.",[13,19],"Drug: Bivalirudin",[21,27,32],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","Cardiohelp device (VA-ECMO)","The Cardiohelp system is a compact cardiopulmonary support system used off-label for ECMO for patients with cardiac and\u002For respiratory failure. It is currently FDA-cleared for \\\u003C6 hours of support for cardiopulmonary bypass.",[16,9],null,{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":26},"DRUG","Heparin","Blood thinner that works by inactivating factor Xa that is administered as a continuous intravenous infusion.",[9],{"type":28,"name":33,"description":34,"armGroupLabels":35,"otherNames":26},"Bivalirudin","Blood thinner that works by inhibiting thrombin directly that is administered as a continuous intravenous infusion.",[16],[37,41],{"name":38,"affiliation":39,"role":40},"Lynn Sleeper, ScD","Boston Children's Hospital","PRINCIPAL_INVESTIGATOR",{"name":42,"affiliation":43,"role":40},"Caroline Ozment, MD","Duke University",[45,50],{"name":46,"role":47,"phone":48,"phoneExt":26,"email":49},"Christopher SD Almond, MD, MPH","CONTACT","6507237913","calmond@stanford.edu",{"name":51,"role":47,"phone":52,"phoneExt":26,"email":53},"Selena Gonzales, MPH","650-723-7913","selena.gonzales@stanford.edu",[55,74,88,101,115],{"facility":56,"status":57,"city":58,"state":59,"zip":60,"country":61,"countryCode":62,"cosmosGeoPoint":63,"geoPoint":68,"contacts":69},"Lucile Packard Children's Hospital","RECRUITING","Palo Alto","California","94304","United States","US",{"type":64,"coordinates":65},"Point",[66,67],-122.14302,37.44188,{"lat":67,"lon":66},[70],{"name":71,"role":47,"phone":72,"phoneExt":26,"email":73},"Kate Ryan, MD","650-724-5554","kateryan@stanford.edu",{"facility":75,"status":57,"city":76,"state":76,"zip":77,"country":61,"countryCode":62,"cosmosGeoPoint":78,"geoPoint":82,"contacts":83},"Cuimc\u002FNyph","New York","10032",{"type":64,"coordinates":79},[80,81],-74.00597,40.71427,{"lat":81,"lon":80},[84],{"name":85,"role":47,"phone":86,"phoneExt":26,"email":87},"Eva Cheung, MD","(212) 305-8458","ec2335@cumc.columbia.edu",{"facility":89,"status":57,"city":90,"state":91,"zip":92,"country":61,"countryCode":62,"cosmosGeoPoint":93,"geoPoint":97,"contacts":98},"Duke University Hospital","Durham","North Carolina","27710",{"type":64,"coordinates":94},[95,96],-78.89862,35.99403,{"lat":96,"lon":95},[99],{"name":42,"role":47,"phone":26,"phoneExt":26,"email":100},"caroline.ozment@duke.edu",{"facility":102,"status":57,"city":103,"state":104,"zip":105,"country":61,"countryCode":62,"cosmosGeoPoint":106,"geoPoint":110,"contacts":111},"Children's Health Dallas","Dallas","Texas","95235",{"type":64,"coordinates":107},[108,109],-96.80667,32.78306,{"lat":109,"lon":108},[112],{"name":113,"role":47,"phone":26,"phoneExt":26,"email":114},"Sirine Baltagi, MD","Sirine.Baltagi@UTSouthwestern.edu",{"facility":116,"status":57,"city":117,"state":118,"zip":119,"country":61,"countryCode":62,"cosmosGeoPoint":120,"geoPoint":124,"contacts":125},"Seattle Children's Hospital","Seattle","Washington","98105",{"type":64,"coordinates":121},[122,123],-122.33207,47.60621,{"lat":123,"lon":122},[126],{"name":127,"role":47,"phone":128,"phoneExt":26,"email":129},"Michael McMullan, MD","206-987-2015","michael.mcmullan@seattlechildrens.org",{"type":40,"investigatorFullName":131,"investigatorTitle":132,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Christopher Almond","Professor of Pediatrics",[134,135,136],{"name":39,"class":6},{"name":43,"class":6},{"name":137,"class":138},"FDA Office of Orphan Products Development","FED","100522242","phase-2-multicenter-trial-of-ecmo-in-children-with-severe-cardiac-failure-using-the-cardiohelp-system-100522242",false,"NCT06080074","Multicenter Trial of ECMO in Children With Severe Cardiac Failure Using the Cardiohelp System","Multicenter Trial to Evaluate the Safety and Effectiveness of the Cardiohelp System for up to 30 Days of Support in Children With Severe Cardiac Failure","TROLLEY","Inclusion Criteria:\n\n1. Age 0 to 16 years of age (i.e., \\\u003C17 years)\n2. Body weight 3 to 80 kilograms\n3. VA-ECMO use for primary cardiac failure using the Cardiohelp system.\n4. First ECMO run during the current hospitalization\n\nExclusion Criteria:Children must not meet any of the following exclusion criteria within 48 hours prior to device implant:\n\n1. Gestationally-corrected age \\\u003C37 weeks\n2. Bleeding or coagulopathy that is a contraindication to anticoagulation\n3. Irreversible renal, hepatic or lung failure\n4. Stroke or uncertain neurological status within the past 30 days\n5. Severely malnourished\n6. Use of an ECMO system other than the Cardiohelp\n7. VV-ECMO or ECMO for primary respiratory failure\n8. Goals of patient to focus on comfort measures only.\n9. Failure to separate from cardiopulmonary bypass\n10. Allergy or contraindication to receiving UFH or bivalirudin as a primary anticoagulant on ECMO.\n11. Patients who are pregnant or breastfeeding.\n12. Unable to undergo randomization within 30 hours following ECMO cannulation (randomized cohort only)","ALL","0 Years","16 Years",{"count":151,"type":152},50,"ESTIMATED","INTERVENTIONAL",[155],"PHASE2","There are two primary goals of this multicenter clinical trial that combines an FDA device trial and a phase II drug trial in the same study cohort. These two goals are to:\n\n1. To evaluate the safety and effectiveness of the Cardiohelp Device for VA-ECMO (heart-lung support) for up to 30 days of support in children with severe heart failure with the goal to support its FDA clearance in children.\n2. To evaluate heparin versus bivalirudin as the primary blood thinner (anticoagulant) in a randomized trial of children supported with the Cardiohelp ECMO System with the goal to plan a phase III (pivotal) randomized clinical trial\n\nThe main questions the Cardiohelp single-arm trial seeks to answer are:\n\n* What is the safety and effectiveness of the Cardiohelp device for pediatric ECMO?\n* Should the Cardiohelp device be FDA-cleared for children based on the results of the study?\n* What are the optimal performance specifications of the Cardiohelp device in children?\n\nThe main questions the blood thinner randomized trial seeks to answer are:\n\n* Which blood thinner is more promising (i.e., more effective and safer) in children on the Cardiohelp device?\n* How should a pivotal trial of heparin vs. bivalirudin be designed so it is the most informative and efficient to determine the best blood thinner?\n\nChildren who are receiving the Cardiohelp device will be approached and consented to participate if interested. For the Cardiohelp device trial, participants will undergo a standardized data collection to estimate survival to 30 days and the prevalence of serious adverse events like stroke, bleeding, and hemolysis. For the blood thinner randomized trial, participants will be randomized 1:1 to blood thinner strategy to determine which blood thinner has the fewest bleeding and clotting complications.\n\nFor the Cardiohelp single-arm trial, participant outcomes will be compared to performance goals (PG) derived from the ECMO literature. For the blood thinner randomized trial, the amount of bleeding and clotting will be measured.\n\nThe study is funded by an R01 grant from the FDA's Office of Orphan Product Development (OOPD).",[158,159,160,161],"Heart Failure","Cardiogenic Shock","Congenital Heart Disease","Cardiomyopathies",[163,164,165,166,167,168,169,170],"blood thinner","ECMO","heart failure","bivalirudin","heparin","FDA regulation","pediatric medical devices","510k clearance","2026-01-27",{"date":173,"type":174},"2026-01-29","ACTUAL",{"date":176,"type":174},"2025-04-15",{"date":178,"type":152},"2029-09",{"name":5,"class":6},5]