[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"XVIVO Perfusion\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":87},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,41,63],{"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":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100635738","xvivo-heart-transplant-study-in-clinical-practice-100635738",false,"NCT07556588","XVIVO Heart Transplant Study in Clinical Practice","Application of Hypothermic Oxygenated Perfusion in Donor Heart Preservation in Clinical Practice - HOPE for All","HOPE for All","Inclusion Criteria Recipient:\n\n1. Age ≥18 years\n2. Signed informed consent form\n3. Accepted or listed for heart transplantation\n\nInclusion Criteria Heart Donor:\n\n1. Accepted as a heart donor by the transplant team based on current standard of care criteria\n2. DBD or DCD Maastricht category III or euthanasia donors\n\nExclusion Criteria Recipient:\n\n1. Not able to understand the information provided during the informed consent procedure\n2. Combined organ transplantation candidates\n\nExclusion Criteria Heart Donor:\n\n1. Functional warm ischemia time (FWIT) \\> 30 minutes (DCD).\n2. Donor cardiac arrest does not occur within 120 minutes from Withdrawal of life sustaining therapy (DCD)\n3. Deviations from Donor end of life treatment protocol as defined by local standard operating procedures\n4. Donor heart assessed as not transplantable by the responsible clinician at any time point during the donation or procurement procedure","ALL","18 Years",{"count":20,"type":21},20,"ESTIMATED","INTERVENTIONAL",[24],"NA","HOPE for All is a clinical investigation to support the use of hypothermic oxygenated perfusion (HOPE) using a revised XVIVO Heart Assist Transport System in a real- world setting.\n\nThe trial will investigate the application of HOPE in a broad population of Donation after Brain Death (DBD) and Donation after Circulatory Death (DCD) donor hearts transplanted to any listed adult patient.\n\nThe hypothesis is that the use of HOPE is safe and feasible for any adult patient awaiting a heart transplantation.\n\nPrimary objective is to evaluate patient survival in the real world setting after heart transplantation, where HOPE using the revised XVIVO Heart Assist Transport System is used for donor heart preservation.\n\nSecondary objective(s) are to evaluate patient outcomes and graft function post-transplant.\n\nHOPE for All is a prospective, single-armed single-centre proof-of-consept trial.",[27],"Heart Failure","RECRUITING","2026-04-21",{"date":31,"type":32},"2026-04-29","ACTUAL",{"date":34,"type":21},"2026-04-15",{"date":36,"type":21},"2028-04-15",{"name":38,"class":39},"XVIVO Perfusion","INDUSTRY",1,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":48,"targetDuration":4,"studyType":22,"phases":50,"briefSummary":51,"conditions":52,"keywords":4,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":58,"completionDateStruct":60,"leadSponsor":62,"locationsCount":4},"100586511","open-label-trial-of-deceased-donor-livers-transplanted-after-dhope-with-exvivo-liver-perfusion-100586511","NCT06916325","Open Label Trial of Deceased Donor Livers Transplanted After DHOPE With eXVIVO LIVER Perfusion","DeLIVER Trial: A Prospective, Multi-Center, Single-Arm, Open Label Trial of Deceased Donor Livers Transplanted After DHOPE With eXVIVO LIVER Perfusion","Participant Inclusion Criteria:\n\n1. Participant is able to provide informed consent and HIPAA authorization\n2. Age ≥18 years\n3. Participant is registered as an active first-time liver transplant candidate on the United Network for Organ Sharing (UNOS) waiting list for primary liver transplantation\n\n   \\- For participants with hepatocellular carcinoma (HCC) as indication for Orthotopic Liver Transplantation, the tumor must be within Milan Criteria or down-staged to Milan Criteria at the time of transplant\n4. Participant is willing to comply with the study requirements and procedures\n\nParticipant Exclusion Criteria:\n\n1. Participant will undergo concurrent multi-organ transplantations (liver-kidney, liver-lung, etc.)\n2. Participant is listed for liver transplantation due to fulminant liver failure (UNOS status 1A)\n3. Participant is listed for a repeat liver transplantation (\\>1 graft)\n4. Participant is pregnant\n5. Participant is on respiratory (ventilator dependent) and\u002For cardiocirculatory support (defined as mechanical circulatory support which requires at least one intravenous inotrope to maintain hemodynamics)\n6. Participant is enrolled in an interventional clinical trial with an investigational drug or device\n7. Presence of other medical, social, or psychological conditions that in the investigator's opinion, could limit the participant's ability to participate in the clinical trial",{"count":49,"type":21},215,[24],"The purpose of this clinical study is to confirm the safety and effectiveness of dual hypothermic oxygenated perfusion (DHOPE) using the Liver Assist to preserve deceased donor livers for transplantation.",[53,54],"Liver Transplant Surgery","Liver Transplantation","NOT_YET_RECRUITING","2026-04-16",{"date":29,"type":32},{"date":59,"type":21},"2027-01",{"date":61,"type":21},"2033-04",{"name":38,"class":39},{"id":64,"slug":65,"hasResults":11,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":69,"eligibilityCriteria":70,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":71,"targetDuration":4,"studyType":22,"phases":73,"briefSummary":74,"conditions":75,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":86},"100584877","xvivo-heart-box-xhb-with-supplemented-xvivo-heart-solution-sxhs-continued-access-protocol-cap-100584877","NCT06895070","XVIVO Heart Box (XHB) With Supplemented XVIVO Heart Solution (SXHS) Continued Access Protocol (CAP)","PRESERVE CAP: A Prospective, Multi-Center, Single-Arm, Open-Label Study of Hearts Transplanted After Non-Ischemic Heart Preservation From Extended Donors Continued Access Protocol","NIHP-CAP-001","Inclusion Criteria Recipient:\n\nTo be eligible to participate in this study, a recipient must meet all the following criteria:\n\n1. Age ³18 years.\n2. Signed informed consent form (ICF).\n3. Listed for heart transplantation.\n\nExclusion Criteria Recipient:\n\n1. Previous solid organ or bone marrow transplantation.\n2. Requires a multi-organ transplant.\n3. Subject is enrolled and ongoing in another investigational pharmaceutical or medical device clinical trial (Exception: observational studies are permitted).\n4. Subject is on mechanical circulatory support pre-transplant other than durable LVAD, Impella or intra-aortic balloon pump (IABP).\n5. History of complex congenital heart disease ie: single ventricle physiology (per Investigator's discretion and XVIVO review).\n6. Subject on renal replacement therapy\u002Fdialysis.\n7. Ventilator dependence (subject is intubated at time of transplant\u002Funable to provide consent or re-affirmation of consent).\n8. Sensitized participants meeting any of the following:\n\n   * Participant with calculated Panel Reactive Antibody (cPRA) greater than 50%\n   * Participant undergoing any desensitization treatment (also with cPRA less than 50%)\n   * Participant with a positive prospective crossmatch and\u002For a positive virtual cross match\n\nDonor Inclusion Criteria:\n\nTo be eligible to participate in this study, the donor heart must meet the following criteria:\n\n1. Estimated Cross Clamp Time ≥4 hours OR\n2. Estimated Cross Clamp ≥ 2 hours AND\n\nAny one or more of the following:\n\n* Age ≥50 years\n* LVEF 40% - 50% at time of provisional acceptance. (Refer to section 6.3.4 for definition of provisional acceptance).\n* Down-time ≥20 minutes\n* Hypertrophy septal thickness \\>12 - ≤16mm\n* Angiographic luminal irregularities with no significant CAD OR 1) Donation after Circulatory Death (DCD)\n\nDonor Exclusion Criteria:\n\nDonor hearts that meet any of the following criteria will be excluded from transplantation in this study:\n\n1. Unstable hemodynamics requiring high-dose inotropic support.\n2. Significantly abnormal coronary angiogram defined as CAD \\> 50% stenosis of one or more vessels or if the donor heart exhibits any contusions, structural damage, gross abnormalities, or palpable CAD on final examination.\n3. Moderate to severe cardiac valve pathology.\n4. Investigator's clinical decision to exclude from trial.\n5. Previous sternotomy.",{"count":72,"type":21},60,[24],"The purpose of this study is to evaluate if Non-Ischemic Heart Preservation (NIHP) of extended criteria donor hearts using the XVIVO Heart Preservation System (XHPS) is a safe and effective way to preserve and transport hearts for transplantation.",[76,27,77],"Heart Transplant","Transplant; Failure, Heart","2026-03-16",{"date":80,"type":32},"2026-03-18",{"date":82,"type":32},"2025-07-10",{"date":84,"type":21},"2031-05",{"name":38,"class":39},14,""]