[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"univentricular-heart\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:univentricular-heart":24},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,7,0,[8,46,71,104,133,164,187],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":4,"briefSummary":21,"conditions":22,"keywords":25,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100634093","fontan-outcomes-in-oligemia-vs-plethora-in-univentricular-chd-100634093",false,"NCT07535203","Fontan Outcomes in Oligemia vs Plethora in Univentricular CHD","Comparison of Outcomes of Pulmonary Oligemia Versus Pulmonary Plethora in Cyanotic Congenital Heart Disease With Univentricular Heart After Fontan Procedure","Inclusion Criteria:\n\n* Diagnosed cyanotic CHD\n* Univentricular heart physiology\n* Planned staged palliation including Fontan procedure\n* Informed consent obtained (patient or guardian)\n\nExclusion Criteria:\n\n* Refusal to participate\n* Incomplete clinical data\n* Inability to complete follow-up","ALL",{"count":18,"type":19},52,"ESTIMATED","OBSERVATIONAL","This prospective cohort study evaluates differences in clinical outcomes between pulmonary oligemia and pulmonary plethora in patients with cyanotic congenital heart disease and univentricular heart physiology undergoing staged palliation culminating in the Fontan procedure.Fifty-two patients will be classified into two groups based on pulmonary blood flow characteristics and followed for approximately 1.5 years after the Fontan procedure. Outcomes include mortality, morbidity, pulmonary hemodynamics, functional capacity, neurocognitive status, and quality of life.",[23,24],"Congenital Heart Disease (CHD)","Univentricular Heart",[26,27,28,29,30,31,32],"univentricular heart","congenital heart disease","fontan procedure","pulmonary blood flow","oligemia","plethora","pulmonary hemodynamics","RECRUITING","2026-04-14",{"date":36,"type":37},"2026-04-17","ACTUAL",{"date":39,"type":37},"2025-01-01",{"date":41,"type":19},"2027-06",{"name":43,"class":44},"Sisca Natalia Siagian","OTHER",1,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":20,"phases":4,"briefSummary":55,"conditions":56,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":5},"100633875","occlutech-afr-fontan-study-100633875","NCT07532369","Occlutech AFR Fontan Study","Clinical Experience With the Occlutech Atrial Flow Regulator (Occlutech AFR) in a Failing Fontan Population","Inclusion Criteria:\n\n* The patient has been treated with an AFR device (attempted or successful) for failing Fontan through the Expanded Access Program of the Food and Drug Administration (FDA).\n* The candidate\u002Fcandidate's legal guardian has been informed of the nature of the study, agrees to its provisions and has provided written informed consent unless the site's IRB provided a waiver of consent.\n\nExclusion Criteria:\n\n* If a subject does not meet the eligibility criteria, they will be considered a Screen Failure and cannot be included",{"count":54,"type":19},25,"The goal of this observational clinical study look at the safety and effectiveness of the Occlutech Atrial Flow Regulator in the treatment of patients with failing Fontan circulation. This study will consist of a case series of congenital patients with Fontan failure who have been treated with an Occlutech AFR under the FDA's Expanded Access process.\n\nThe scope of this study is to gain clinical experience on the Occlutech AFR in Fontan failure patients. Cases in this study will be evaluated to evaluate the safety and effectiveness of the device.\n\nThe objective of this study is to evaluate the Occlutech AFR with respect to device safety and shunt patency at 1 year. Shunt patency defined by persistent right to left shunt assessed by echocardiography at 1-year post-procedure.",[57,58,24,59],"Failure of Fontan Type Circulation","Fenestration","Congenital Anomaly","NOT_YET_RECRUITING","2026-04-08",{"date":63,"type":37},"2026-04-15",{"date":65,"type":19},"2026-05-01",{"date":67,"type":19},"2026-09",{"name":69,"class":70},"Occlutech International AB","INDUSTRY",{"id":72,"slug":73,"hasResults":11,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":4,"eligibilityCriteria":77,"healthyVolunteers":11,"sex":16,"minAge":78,"maxAge":79,"enrollmentInfo":80,"targetDuration":4,"studyType":82,"phases":83,"briefSummary":85,"conditions":86,"keywords":90,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":45},"100488984","phase-1-autologous-induced-pluripotent-stem-cells-of-cardiac-lineage-for-congenital-heart-disease-100488984","NCT05647213","Autologous Induced Pluripotent Stem Cells of Cardiac Lineage for Congenital Heart Disease","Safety and Feasibility of Autologous Induced Pluripotent Stem Cells of Cardiac Lineage in Subjects With Congenital Heart Disease","Individuals may be considered eligible for enrollment for Part I of this study (Skin Punch Biopsy) if in the best judgment of the Principal Investigator they will meet eligibility criteria outlined below at the time it is determined acceptable investigational product is available for administration (approximately 9 months post skin punch biopsy). Inclusion and exclusion criteria apply to both the treatment and control arms of the study unless otherwise specified.\n\nInclusion Criteria\n\nIndividuals who meet all the following criteria are eligible for enrollment as study participants:\n\n* Age 18 to 40 years old\n* Subject must be able to understand and provide informed consent.\n* Univentricular congenital heart disease.\n* End-stage systolic heart failure, defined as Class IV according to New York Heart Association (NYHA) with abnormal visually estimated ejection fraction below 40%.\n* Prognosis of 1 to 1.5 years survival at time of skin biopsy.\n* The patient falls into one of the following categories:\n\n  * Currently listed for heart transplantation at an accredited program in the US but has an expected waiting time for a suitable organ that is likely longer than anticipated life-expectancy.\n  * Has been denied access to a heart transplantation at an accredited US institution.\n  * Is currently on or planning to be on mechanical support as destination therapy.\n* All guideline directed therapy available to the subject has been maximized, for a minimum of 3 months prior to enrollment.\n* Adequate social support system that facilitates subject participation in all study required tests and procedures and supports the subject's ability to comply with long-term study requirements.\n\nExclusion Criteria\n\nIndividuals who meet any of the following criteria are not eligible for enrollment as study participants:\n\n* No available autologous iPSC-CL as defined by the manufacturer's release criteria. (This applies to Part II of the study and applies to the treatment arm only.)\n* History of symptomatic episodes of cardiac arrythmia requiring cardiac defibrillation or escalation of medications.\n* Heart failure with preserved ejection fraction.\n* Heart failure due to co-morbid conditions (e.g., amyloidosis, valvular heart disease, refractory anemia).\n* QTc greater than 500 ms.\n* Stage III or higher chronic kidney disease.\n* History of liver cirrhosis.\n* History of coronary artery disease.\n* Uncontrolled diabetes mellitus.\n* Any history of cancer.\n* Contraindication for use of amiodarone for up to 3 months (treatment arm only).\n* Contraindication for insertion of Insertable Cardiac Monitor.\n* Contraindication for placement of LifeVest cardioverter defibrillator.\n* Positive serology testing for HIV, Hepatitis B, Hepatitis C or Syphilis.\n* Obesity with BMI greater than 30.\n* Current alcohol or drug abuse precluding heart transplantation.\n* Active infection requiring ongoing treatment.\n* Contraindication to anesthesia.\n* Past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or that may impact the quality of the data obtained from the study.\n* Inability or unwillingness of a participant to give written informed consent or comply with study protocol.\n* History of non-compliance.\n* Inability to be accompanied around the clock for any part of the first 3 weeks post product administration.\n* Uncontrolled depression.\n* Denied heart transplant due to social determinants.\n* Current participation in another cardiac interventional clinical trial that could confound the results of this study.\n* Previous heart transplant.","18 Years","40 Years",{"count":81,"type":19},50,"INTERVENTIONAL",[84],"PHASE1","The goal of this clinical trial is to test the safety of lab-grown heart cells made from stem cells in subjects with congenital heart disease. The main questions it aims to answer are:\n\n* Is this product safe to deliver to humans\n* Is the conduct of this trial feasible\n\nParticipants will be asked to:\n\n* Agree to testing and monitoring before and after product administration\n* Receive investigational product\n* Agree to lifelong follow-up Researchers will compare subjects from the same pool to see if there is a difference between treated and untreated subjects.",[24,87,88,89],"Congenital Heart Disease","Heart Failure NYHA Class III","Heart Failure NYHA Class IV",[91,92,93,94],"univentricular","heart disease","iPSC","induced pluripotent stem cell","2026-03-11",{"date":97,"type":37},"2026-03-13",{"date":99,"type":37},"2023-02-03",{"date":101,"type":19},"2029-02",{"name":103,"class":44},"HeartWorks, Inc.",{"id":105,"slug":106,"hasResults":11,"nctId":107,"briefTitle":108,"officialTitle":108,"acronym":109,"eligibilityCriteria":110,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":111,"targetDuration":113,"studyType":20,"phases":4,"briefSummary":114,"conditions":115,"keywords":120,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":124,"lastUpdatePostDateStruct":125,"startDateStruct":127,"completionDateStruct":129,"leadSponsor":131,"locationsCount":45},"100422546","registry-to-assess-the-safety-and-feasibility-of-the-subpulmonary-support-with-the-novel-venous-cannula-in-patients-with-failingabsence-of-the-right-heart-100422546","NCT04782232","Registry to Assess the Safety and Feasibility of the Subpulmonary Support with the Novel Venous Cannula in Patients with Failing\u002FAbsence of the Right Heart","RegiVe","Inclusion Criteria:\n\n* Patient or his\u002Fher parent\u002Fguardian or legally authorized representative has given the consent by means of a written, signed and dated informed consent form,\n* The indications on RVAD and BVAD use of the EXCOR VAD apply,\n* Patient shall be on transplant list or at least eligible for HTx,\n* BSA (body surface area) greater than or equal to 1.2 m².\n\nExclusion Criteria:\n\n* Patient or his\u002Fher parents\u002Flegal guardian or legally authorized guardian has not given the consent,\n* The contraindications of EXCOR VAD apply.",{"count":112,"type":19},20,"12 Months","The purpose of the study is to monitor the clinical safety and performance of the EXCOR Venous Cannula in context of an EXCOR VAD therapy to ensure continued acceptability of identified risks, to enable detecting emerging risks and to assess clinical improvement on both short- and long-term.",[116,24,117,118,119],"Heart Failure","Ventricular Dysfunction","Heart Diseases","Cardiovascular Diseases",[121,122,123],"EXCOR Ventricular Assist Device","EXCOR Venous Cannula","Failing Fontan","2025-02-13",{"date":126,"type":37},"2025-02-17",{"date":128,"type":37},"2021-06-01",{"date":130,"type":19},"2027-09",{"name":132,"class":70},"Berlin Heart GmbH",{"id":134,"slug":135,"hasResults":11,"nctId":136,"briefTitle":137,"officialTitle":138,"acronym":139,"eligibilityCriteria":140,"healthyVolunteers":11,"sex":16,"minAge":78,"maxAge":4,"enrollmentInfo":141,"targetDuration":143,"studyType":20,"phases":4,"briefSummary":144,"conditions":145,"keywords":148,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":155,"lastUpdatePostDateStruct":156,"startDateStruct":158,"completionDateStruct":160,"leadSponsor":162,"locationsCount":45},"100572611","cardiac-magnetic-resonance-stress-perfusion-study-in-patinets-with-fontan-circulation-100572611","NCT06735521","Cardiac Magnetic Resonance Stress-perfusion Study in Patinets with Fontan Circulation","Att Överleva Och Leva Som Vuxen Med Enkammarhjärta I Sverige","CMR_TCPC","Inclusion Criteria:\n\n* Patients who had undergone total cavo-pulmonary connection (TCPC) surgery resulting in Fontan circulation.\n* NYHA (New York Heart Assosiation) class I-II.\n* Understanding the study information (signed informed consent).\n* \\>18 years old.\n\nExclusion Criteria:\n\n* Device therapy (pacemaker, ICD).\n* Failing Fontan (NYHA III-IV).\n* Kidney failure (GFR\\\u003C30ml\u002Fh).\n* Arrythmia (atrial fibrillation).\n* Pregnancy.",{"count":142,"type":19},30,"1 Year","Univentricular heart (UVH) is a severe congenital heart disease. Accurate advanced non-invasive diagnostic methods is limited. Cardiovascular magnetic resonance (CMR) imaging has evolved as a particularly useful tool for the study of patients with adult congenital heart disease (ACHD) considering its ability to determine detailed anatomy and detect early cardiac dysfunction without the need for radiation exposure. Most of contemporary treatment recommendations are based on consensus opinions\u002Fdocuments and small studies from local, or national registries. Improved knowledge is needed in all these areas to facilitate clinical decisions regarding treatment, monitoring and follow-up.\n\nThis study seeks to answer if early detection of deterioration in cardiac function, venous pressure and microvascular dysfunction can identify patients before the symptoms progress and thus help to initiate early treatment. The hypothesis is that quantitative myocardial stress-perfusion maps improves the pathophysiological insight in patients with UVH.\n\nThe overall goal with this research proposal is to implement combined advanced CMR imaging for a comprehensive non-invasive mapping of functional cardiovascular behavior in patients with complex UVH disease. The outcome of this research may benefit this young adult patient population due to early detection of cardiac disease, less hospitalizations because of heart failure, and eventually decrease morbidity and mortality.",[24,146,116,147],"Microvascular Dysfunction","Magnetic Resonance",[149,150,151,152,153,154],"Fontan circulation","CMR","stress-perfusion","tissue characterization","univentricle heart","TCPC","2024-12-13",{"date":157,"type":37},"2024-12-16",{"date":159,"type":37},"2024-04-15",{"date":161,"type":19},"2025-09-01",{"name":163,"class":44},"Karolinska Institutet",{"id":165,"slug":166,"hasResults":11,"nctId":167,"briefTitle":168,"officialTitle":169,"acronym":4,"eligibilityCriteria":170,"healthyVolunteers":11,"sex":16,"minAge":171,"maxAge":172,"enrollmentInfo":173,"targetDuration":4,"studyType":82,"phases":174,"briefSummary":176,"conditions":177,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":178,"lastUpdatePostDateStruct":179,"startDateStruct":181,"completionDateStruct":183,"leadSponsor":185,"locationsCount":45},"100486896","prospective-evaluation-of-univentricular-hearts-100486896","NCT05620030","Prospective Evaluation of Univentricular Hearts","Evaluation of the Standard Data Collected as Part of the Erlangen Protocol for the Treatment and Monitoring of Patients With Univentricular Heart Defects in Terms of the Fontan Procedure","Inclusion Criteria:\n\n* congenital heart defect of the univentricular type and the clinical necessity of a multi-stage treatment in terms of the Fontan procedure.\n\nExclusion Criteria:\n\n* no exclusion criteria","6 Years","60 Years",{"count":142,"type":19},[175],"NA","Univentricular heart defects are among the most complex congenital malformations. The treatment of these patients usually includes 3 operations and accompanying diagnostics, some of which are invasive, within the first 3 to 4 years of life until the \"fontan circulation\" is established. Unfortunately, the group of patients with a univentricular cardiac malformation is also the group with the highest mortality rate until the Fontan circulation is established. The expected mortality varies depending on the complexity of the underlying intracardiac and extracardiac malformations and possible concomitant morbidity; According to data from the National Quality Assurance in Germany, it is currently up to 30% in patients with hypoplastic left heart syndrome. However, the treatment methods are well standardized and there has been a clinical protocol in Erlangen since 2008 that includes diagnostic examinations using cardiac catheterization (HKU) and magnetic resonance imaging (MRT), as well as non-invasive, instrument-based diagnostics and targeted blood tests in a consistent sequence before and after the operations regulates. The Erlangen protocol ends with the cardiac MRT six months after the Fontan operation (syn: total cavopulmonary connection \\[TCPC\\]). If MRT imaging is not possible (e.g. if a cardiac pacemaker is present) or if there is a clinical indication (e.g. an obstruction noticeable on MRT or the presence of an \"overflow with right-left shunt\"), HKU is performed in the first year after TCPC. These examinations are used to depict hemodynamics, cardiac function, vascular development, and lymphatic drainage disorders in order to evaluate the preoperative risk, adapt treatment strategies to the individual, and identify complications at an early stage. This concept is based on clinical experience and current scientific findings and has proven itself in everyday clinical practice since its introduction for Erlangen-Fontan patients and has proven to be very helpful for individualized treatment. After a successful Fontan operation, the mortality risk in childhood is only low. In the long term, however, some of the patients unfortunately suffer from Fontan-typical long-term complications with protein-loss enteropathy having to be mentioned in particular, which is described in the literature with an incidence of 3-14% and today still a 5-year incidence-has a mortality risk of 6-12%.",[24],"2022-11-10",{"date":180,"type":37},"2022-11-17",{"date":182,"type":37},"2021-05-20",{"date":184,"type":19},"2041-05-20",{"name":186,"class":44},"University of Erlangen-Nürnberg Medical School",{"id":188,"slug":189,"hasResults":11,"nctId":190,"briefTitle":191,"officialTitle":192,"acronym":4,"eligibilityCriteria":193,"healthyVolunteers":11,"sex":16,"minAge":171,"maxAge":172,"enrollmentInfo":194,"targetDuration":4,"studyType":82,"phases":196,"briefSummary":197,"conditions":198,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":199,"lastUpdatePostDateStruct":200,"startDateStruct":202,"completionDateStruct":204,"leadSponsor":206,"locationsCount":45},"100482541","fontan-sprechstunde-100482541","NCT05563376","Fontan-Sprechstunde","Prospektive Erfassung Von standardmäßig Erhobenen Daten im Rahmen Der Erlanger Fontan-Sprechstunde Zur Behandlung Und Überwachung Von PatientInnen Mit univentrikulärem Herzfehler im Sinne Einer Fontan-Zirkulation","Inclusion Criteria:\n\n* congenital heart defect of the univentricular type that has led to Fontan circulation\n\nExclusion Criteria:\n\n* no exclusion criteria",{"count":195,"type":19},200,[175],"After successful Fontan surgery, the risk of mortality in childhood is only low. Unfortunately, some of the patients suffer from Fontan-typical long-term complications in the long-term course, whereby protein loss neuropathy must be mentioned in particular, which is described in the literature with an incidence of 3-14% (1, 2) and still has a 5-year risk of death of 6-12% today (2, 3). Protein loss tereopathy leads to loss of protein in the intestine and subsequently to diarrhea and edema. Other problems concern the liver, which can develop cirrhosis due to chronic congestion (4-6). Cardiac can lead to heart failure and arrhythmias.\n\nThe registry study described in this protocol is intended to identify factors that influence the treatment outcome of patients in the Fontan circulation in the long term through systematic prospective documentation of the data from our standardized and guideline-oriented treatment.",[24],"2022-09-28",{"date":201,"type":37},"2022-10-03",{"date":203,"type":37},"2020-09-01",{"date":205,"type":19},"2041-09-01",{"name":186,"class":44}]