[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"heart-failure-nyha-class-iv\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:heart-failure-nyha-class-iv":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,8,0,[8,49,78,103,131,157,181,219],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":31,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100488984","phase-1-autologous-induced-pluripotent-stem-cells-of-cardiac-lineage-for-congenital-heart-disease-100488984",false,"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.","ALL","18 Years","40 Years",{"count":20,"type":21},50,"ESTIMATED","INTERVENTIONAL",[24],"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.",[27,28,29,30],"Univentricular Heart","Congenital Heart Disease","Heart Failure NYHA Class III","Heart Failure NYHA Class IV",[32,33,34,35],"univentricular","heart disease","iPSC","induced pluripotent stem cell","RECRUITING","2026-03-11",{"date":39,"type":40},"2026-03-13","ACTUAL",{"date":42,"type":40},"2023-02-03",{"date":44,"type":21},"2029-02",{"name":46,"class":47},"HeartWorks, Inc.","OTHER",1,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":4,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":16,"minAge":56,"maxAge":57,"enrollmentInfo":58,"targetDuration":4,"studyType":22,"phases":60,"briefSummary":62,"conditions":63,"keywords":64,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":48},"100576942","sustaining-home-heart-failure-palliative-care-in-rural-appalachia-100576942","NCT06791850","Sustaining Home Heart Failure Palliative Care in Rural Appalachia","Sustaining Home Palliative Care for Patients With Heart Failure (HF) and Their Family Caregivers in Rural Appalachia: A Mixed Methods Randomized Clinical Trial (RCT).","Inclusion Criteria:\n\n1. Adult patients' age between 50 to 80 years with advanced HF (NYHA III or IV), diagnosed by physician\n2. Caregivers' age between 45 to 80 years.\n3. Alert and consent to participate\n4. Able to read and understand English\n\nExclusion Criteria:\n\n1. Already received or are on a waiting list for a heart transplant or left ventricular assist device (LVAD)\n2. Diagnosed with a terminal illness or dementia, such as Alzheimer's disease","45 Years","80 Years",{"count":59,"type":21},208,[61],"NA","The aim of this mixed methods randomized controlled trial is to test the integrated nurse-led intervention bundle for family home care management of end-stage heart failure and palliative care in rural Appalachia. This intervention bundle is designed to address rural disparities in access to health care, with the help of the faith-based nurses and local volunteer visiting neighbors.",[29,30],[65,66,67,68],"advanced heart failure","home palliative care","family caregiver","rural Appalachia","2026-03-05",{"date":71,"type":40},"2026-03-09",{"date":73,"type":40},"2025-04-01",{"date":75,"type":21},"2028-05-31",{"name":77,"class":47},"West Virginia University",{"id":79,"slug":80,"hasResults":11,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":84,"eligibilityCriteria":85,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":86,"targetDuration":88,"studyType":89,"phases":4,"briefSummary":90,"conditions":91,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":48},"100380754","real-time-monitoring-of-heart-failure-across-the-yale-new-haven-health-system-100380754","NCT04237701","Real-Time Monitoring of Heart Failure Across the Yale New Haven Health System","Retrospective and Real-Time Monitoring of Heart Failure Across the Yale New Haven Health System Via a Live Registry","Yale-HF","Inclusion Criteria:\n\n* Seen within the Yale New Haven Health System\n* Diagnosis of heart failure\n\nExclusion Criteria:\n\n* Age\\\u003C18",{"count":87,"type":21},40000,"10 Years","OBSERVATIONAL","The Yale HF Registry is a live EHR based registry that allows for retrospective and real-time monitoring of Heart Failure case across the Yale New Haven Health System.",[92,93,94,30],"Heart Failure","Heart Failure With Reduced Ejection Fraction","Heart Failure With Preserved Ejection Fraction","2026-03-02",{"date":69,"type":40},{"date":98,"type":40},"2019-10-01",{"date":100,"type":21},"2030-12-30",{"name":102,"class":47},"Yale University",{"id":104,"slug":105,"hasResults":11,"nctId":106,"briefTitle":107,"officialTitle":108,"acronym":4,"eligibilityCriteria":109,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":110,"targetDuration":4,"studyType":22,"phases":112,"briefSummary":113,"conditions":114,"keywords":117,"overallStatus":121,"whyStopped":4,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":123,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":129,"locationsCount":48},"100600592","reduced-functionality-and-kinesiophobia-in-patients-with-heart-failure-use-of-alternative-therapeutic-strategies-100600592","NCT07099495","REDUCED FUNCTIONALITY AND KINESIOPHOBIA IN PATIENTS WITH HEART FAILURE: USE OF ALTERNATIVE THERAPEUTIC STRATEGIES","Reduced Functionality and Kinesiophobia in Patients With Heart Failure: Use of Neuromuscular Electrical Stimulation as an Alternative Therapeutic Strategy","Inclusion Criteria:\n\n* Individuals of both sexes;\n* Age ≥ 18 years;\n* Diagnosis of chronic HF;\n* Symptoms compatible with Functional Class (FC) III-IV of the New York Heart Association (NYHA);\n* Stable condition on pharmacological therapy;\n* Absence of Acute Myocardial Infarction in the last three months prior to participant recruitment;\n* Absence of an automatic internal cardioverter defibrillator (ICD) or cardiac pacemaker;\n\nExclusion Criteria:\n\n* Individuals with hemodynamic instability, unstable angina, acute myocardial infarction during the period of application of the protocol and diagnosis of hypertrophic cardiomyopathy during the period of application of the protocol;\n* Individuals with recent muscle or tendon injuries, muscular dystrophies, myopathies, unstable fractures, infections or deep vein thrombosis (DVT);\n* Chronic need for oxygen therapy;\n* Absence in reassessments;\n* Refusal to participate in the research after its beginning.",{"count":111,"type":21},54,[61],"Introduction: Heart failure (HF) is a clinical syndrome that has advanced on a large scale concomitant with population aging and other factors. Thus, the search for alternatives that minimize the losses resulting from its structural and functional damage are important to optimize its treatments, with the primary objective of enabling the participation of these individuals in the most diverse daily tasks. Low-frequency (LF) or medium-frequency (MF) neuromuscular electrical stimulation (NMES) can be considered a resource to enable the improvement of vital and functional parameters of the population with HF intolerant to physical exercise, and it is also important to identify within these modalities which is most effective. In addition to these factors, kinesiophobia can be found in this population, and NMES can also be adopted as a strategy for kinesiophobia in these patients, with the objective of enabling the progression of behaviors. Objective: To evaluate and compare the effectiveness of LF and MF NMES on the indices of kinesiophobia and functionality in patients with HF. Methods: The research will be divided into two types of study: a double-blind randomized clinical trial (RCT) to evaluate NMES protocols, and a qualitative study with subsequent development and validation of a questionnaire to measure kinesiophobia in individuals with HF. The population included in the RCT will have their assessments (personal, socioeconomic, demographic data, Sit-to-Stand Test, kinesiological ultrasound and surface electromyography of the quadriceps muscles) conducted before their discharge from Hospital Nova Esperança (HNE), and after completion of the protocols at the same institution, in the city of João Pessoa - Paraíba. The application of NMES protocols will be carried out in the home environment (30 min\u002Fday, 3 times a week, for a total of 8 consecutive weeks). The population for the qualitative study and for the development of the questionnaire will consist of individuals diagnosed with HF of any etiology, compensated and able to perform kinesiotherapy activities, admitted to the HNE wards, between 24-48 hours before hospital discharge. An in-depth semi-structured interview will be conducted with these individuals, followed by the application of questionnaires developed based on the interviews, and the entire study will be conducted while the patients are hospitalized. Expected results: Regarding the first study, it is expected that patients treated with NMES will show improvements in clinical and functional variables, and these improvements may be more pronounced depending on the frequency applied. On the other hand, the qualitative study may reveal whether patients have fear of movement, even if they are clinically stable. The developed questionnaire will be well understood and have adequate psychometric qualities. Finally, it is expected that this knowledge can serve as a basis for optimizing the care of this patient population.",[92,29,30,115,116],"Neuromuscular Electrical Stimulation (NMES)","Kinesiophobia",[118,119,120],"heart failure","neuromuscular electrical stimulation","kinesiophobia","NOT_YET_RECRUITING","2025-07-24",{"date":124,"type":40},"2025-08-01",{"date":126,"type":21},"2025-08-18",{"date":128,"type":21},"2027-12-30",{"name":130,"class":47},"Universidade Federal do Rio Grande do Norte",{"id":132,"slug":133,"hasResults":11,"nctId":134,"briefTitle":135,"officialTitle":136,"acronym":4,"eligibilityCriteria":137,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":138,"targetDuration":4,"studyType":89,"phases":4,"briefSummary":140,"conditions":141,"keywords":144,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":148,"lastUpdatePostDateStruct":149,"startDateStruct":151,"completionDateStruct":153,"leadSponsor":155,"locationsCount":48},"100596453","association-between-the-sit-to-stand-test-and-the-prognosis-of-patients-with-heart-failure-100596453","NCT07045649","Association Between the Sit-To-Stand Test and the Prognosis of Patients With Heart Failure","Association Between Performance in the 1-Minute Sit-To-Stand Test and Clinical and Functional Outcomes of Patients Hospitalized for Heart Failure - Prospective Observational Study","Inclusion Criteria:\n\n* Patients diagnosed with CDI;\n* Over 18 years of age;\n* With an Intensive Care Unit Mobility Scale (IMS) \\> 4 at discharge from the ICU;\n* Able to sit and stand up from a chair without support from the upper limbs (ULs) will be included in the study.\n\nExclusion Criteria:\n\n* Patients with cognitive alterations;\n* Level of consciousness, with \\[RASS (Richmond Agitation and Sedation Scale) \\>+1 or \\\u003C-2 and Glasgow \\\u003C13 (Coma Scale)\\], neurological and orthopedic, which compromise the understanding and performance of the assessment will be excluded;\n* Patients with advanced invasive ventilatory and circulatory support or in cardiogenic shock.",{"count":139,"type":21},68,"Introduction: Heart failure (HF), among cardiovascular diseases, is the disease that has been increasing its incidence and prevalence the most in recent years in the world population, due to the aging of the population. In addition, HF is the most frequent hospital diagnosis in the elderly, and is the main cause of hospitalization, with significant expenditure in public and private health care worldwide. Some functional tests have been used to predict the prognosis in patients with HF, however, the use of the 1-minute sit-to-stand test (SST1) to predict prognosis in HF has little scientific evidence, due to the lack of studies found in the literature for this population. Thus, the present study aims to evaluate the association between SST1 at discharge from the Cardio Intensive Care Unit (ICU) and the clinical outcome after 90 days in patients hospitalized for decompensated heart failure (DHF). Methods: This is a prospective cohort study analyzing the association between performance on the TSL1 and clinical outcome in patients hospitalized for DHF from June 2025 to October 2025. Sociodemographic, family, social, and clinical data will be collected from the participants, after which the TSL1 will be performed. The outcome of death and hospital readmission within 90 days after discharge from the ICU will be identified through telephone contact, which will be carried out by the researcher. Expected results: It is expected that from the results of this study it will be possible to understand whether performance on the TSL1 predicts clinical outcome for patients hospitalized for DHF and that it will even be possible to determine a cutoff point capable of predicting the outcomes of interest.",[92,30,142,29,143],"Heart Failure; With Decompensation","Heart Failure NYHA Class II",[145,146,147],"Functional Status","Hospitalization","Prognosis","2025-07-18",{"date":150,"type":40},"2025-07-23",{"date":152,"type":40},"2025-07-16",{"date":154,"type":21},"2026-02",{"name":156,"class":47},"Centro Universitário Augusto Motta",{"id":158,"slug":159,"hasResults":11,"nctId":160,"briefTitle":161,"officialTitle":162,"acronym":163,"eligibilityCriteria":164,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":165,"enrollmentInfo":166,"targetDuration":4,"studyType":22,"phases":168,"briefSummary":170,"conditions":171,"keywords":4,"overallStatus":121,"whyStopped":4,"lastUpdateSubmitDate":172,"lastUpdatePostDateStruct":173,"startDateStruct":175,"completionDateStruct":177,"leadSponsor":179,"locationsCount":4},"100523576","phase-1-narrative-intervention-for-chronic-illness--heart-failure-trial-nici-hf-100523576","NCT06097481","Narrative Intervention for Chronic Illness- Heart Failure Trial (NICI-HF)","Refining an Asynchronous Narrative-Based Intervention for Adjusting to Heart Failure Chronic Illness to Advance Behavioral Health Equity","NICI-HF","Inclusion Criteria:\n\n* Dx with Heart Failure, NYHA Class III and IV\n* Have an email address and able to check email regularly\n* Have a working phone number\n* Between the ages of 18-89 years old\n\nExclusion Criteria:\n\n* Conflicting research study","89 Years",{"count":167,"type":21},300,[24,169],"PHASE2","The Narrative Intervention for Chronic Illness-Heart Failure (NICI-HF) offers an asynchronous interactive text behavioral health intervention to advance behavioral health equity by facilitating access to care for people adjusting to living with heart failure (HF). The proposed study will recruit up to 70 people living with heart failure. This study will gain insight into living with heart failure and learn if the narrative-based intervention is feasible and acceptable for people living with heart failure. The study has two specific aims:\n\nAim 1: Evaluate the effects of NICI-HF intervention on standard behavioral outcomes. The study investigators will review depression with the Personal Health Questionnaire-9 (primary) and anxiety with the General Anxiety Disorder-7 (secondary) outcomes, and explore self-care with the Self Care for Heart Failure Index by comparing the sham control (n=30) and NICI-HF intervention (n=30) groups at baseline, three months, and six months.\n\nAim 2: Refine NICI-HF for feasibility and acceptability to support HF self-care and burdensome symptom management and to increase behavioral health equity by improving proximity to services. The study investigators will use standard implementation domains to tailor the intervention for HF using qualitative semi-structured interviews and mixed methods analysis. The study investigators will refine and manualize the intervention for future R01 testing across chronic illnesses with diverse and marginalized populations and service delivery models.",[92,29,30],"2024-11-11",{"date":174,"type":40},"2024-11-13",{"date":176,"type":21},"2025-09",{"date":178,"type":21},"2027-11",{"name":180,"class":47},"University of Colorado, Denver",{"id":182,"slug":183,"hasResults":11,"nctId":184,"briefTitle":185,"officialTitle":186,"acronym":187,"eligibilityCriteria":188,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":189,"enrollmentInfo":190,"targetDuration":4,"studyType":22,"phases":191,"briefSummary":192,"conditions":193,"keywords":198,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":210,"lastUpdatePostDateStruct":211,"startDateStruct":213,"completionDateStruct":215,"leadSponsor":217,"locationsCount":48},"100487848","atrial-appendage-micrograft-transplants-to-assist-heart-repair-after-cardiac-surgery-100487848","NCT05632432","Atrial Appendage Micrograft Transplants to Assist Heart Repair After Cardiac Surgery","Autologous Atrial Appendage Micrografts Transplanted During Coronary Artery Bypass Surgery: the AAMS2 Randomized, Double-blinded, and Placebo-controlled Trial","AAMS2","Inclusion Criteria:\n\n* Informed consent obtained\n* Left ventricular ejection fraction (LVEF) between ≥ 15% and ≤ 40% at recruitment (transthoracic echocardiography)\n* New York Heart Association (NYHA) Class II-IV heart failure symptoms\n\nExclusion Criteria:\n\n* Heart failure due to left ventricular outflow tract obstruction\n* Acute myocardial infarction (AMI) within last 30 days\n* History of life-threatening and possibly repeating ventricular arrhythmias or resuscitation, or an implantable cardioverter-defibrillator\n* Stroke or other disabling condition within 3 months before screening\n* Severe valve disease or scheduled valve surgery\n* Renal dysfunction (GFR \\\u003C45 ml\u002Fmin\u002F1.73m2)\n* Other disease limiting life expectancy\n* Contraindications for coronary angiogram or LGE-CMRI\n* Participation in some other clinical trial\n\nScreening Failure:\n\n* After optimization of medications, no visible scar or LVEF ≥ 50% in preoperative LGE-CMRI\n* Preoperative LGE-CMRI has not been performed prior scheduled CABG","75 Years",{"count":20,"type":21},[61],"Ischemic heart disease (IHD) leads the global mortality statistics. Atherosclerotic plaques in coronary arteries hallmark IHD, drive hypoxia, and may rupture to result in myocardial infarction (MI) and death of contractile cardiac muscle, which is eventually replaced by a scar. Depending on the extent of the damage, dysbalanced cardiac workload often leads to emergence of heart failure (HF).\n\nThe atrial appendages, enriched with active endocrine and paracrine cardiac cells, has been characterized to contain cells promising in stimulating cardiac regenerative healing.\n\nIn this AAMS2 randomized controlled and double-blinded trial, the patient's own tissue from the right atrial appendage (RAA) is for therapy. A piece from the RAA can be safely harvested upon the set-up of the heart and lung machine at the beginning of coronary artery bypass (CABG) surgery. In the AAMS2 trial, a piece of the RAA tissue is processed and utilized as epicardially transplanted atrial appendage micrografts (AAMs) for CABG-support therapy.\n\nIn our preclinical evaluation, epicardial AAMs transplantation after MI attenuated scarring and improved cardiac function. Proteomics suggested an AAMs-induced glycolytic metabolism, a process associated with an increased regenerative capacity of myocardium. Recently, the safety and feasibility of AAMs therapy was demonstrated in an open-label clinical study. Moreover, as this study suggested increased thickness of the viable myocardium in the scarred area, it also provided the first indication of therapeutic benefit.\n\nBased on randomization with estimated enrolment of a total of 50 patients with 1:1 group allocation ratio, the piece of RAA tissue is either perioperatively processed to AAMs or cryostored. The AAMs, embedded in a fibrin matrix gel, are placed on a collaged-based matrix sheet, which is then epicardially sutured in place at the end of CABG surgery. The location is determined by preoperative late gadolinium enhancement cardiac magnetic resonance imaging (LGE-CMRI) to pinpoint the ischemic scar. The controls receive the collagen-based patch, but without the AAMs. Study blood samples, transthoracic echocardiography (TTE), and LGE-CMRI are performed before and at 6-month follow-up after the surgery.\n\nThe trial's primary endpoints focus on changes in cardiac fibrosis as evaluated by LGE-CMRI and circulating levels of N-terminal prohormone of brain natriuretic peptide (NT-proBNP). Secondary endpoints center on other efficacy parameters, as well as both safety and feasibility of the therapy.",[194,195,196,29,143,30,197],"Ischemic Heart Disease","Ischemic Cardiomyopathy","Heart Failure, Systolic","Coronary Artery Disease",[199,200,201,202,203,204,205,206,207,208,209],"Ischemic heart failure","Ischemic heart disease","Coronary artery disease","Coronary artery bypass grafting","Atrial appendage micrografts","Tissue-engineering","Ischemic cardiomyopathy","Atrial appendage","Micrografts","Cell Therapy","Epitranscriptomics","2024-04-18",{"date":212,"type":40},"2024-04-19",{"date":214,"type":40},"2024-04-01",{"date":216,"type":21},"2026-12-31",{"name":218,"class":47},"Hospital District of Helsinki and Uusimaa",{"id":220,"slug":221,"hasResults":11,"nctId":222,"briefTitle":223,"officialTitle":224,"acronym":4,"eligibilityCriteria":225,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":226,"targetDuration":4,"studyType":22,"phases":228,"briefSummary":229,"conditions":230,"keywords":232,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":241,"lastUpdatePostDateStruct":242,"startDateStruct":244,"completionDateStruct":246,"leadSponsor":248,"locationsCount":48},"100250363","study-of-the-clinical-impact-of-surgical-correction-of-tricuspid-insufficiency-in-implantable-lvad-patients-100250363","NCT02537769","Study of the Clinical Impact of Surgical Correction of Tricuspid Insufficiency in Implantable LVAD Patients","Randomized Study of the Clinical Impact of Surgical Correction of Tricuspid Insufficiency in Implantable LVAD Patients","Inclusion Criteria:\n\n1. Participant or their legal representative has signed an informed consent\n2. Over 18 years of age\n3. Participant with advanced heart failure symptoms (Class III or IV) and preoperative mild tricuspid regurgitation who are scheduled for an implantable LVAD\n\nExclusion Criteria:\n\n1. Prior tricuspid valve repair\n2. Any evidence of structural (chordal or leaflet) tricuspid valve disease\n3. Technical obstacles, which pose an inordinately high surgical risk, in the judgment of the investigator\n4. Existence of any ongoing mechanical circulatory support other than intra-aortic balloon counter pulsation\n5. Body Mass Index (BMI) \\> 45\n6. Pregnancy\n7. Presence of mechanical aortic valve that will not be converted to a bioprosthesis at time of LVAD implant\n8. History of cardiac transplant or cardiomyoplasty\n9. Psychiatric disease, irreversible cognitive dysfunction or psychosocial issues that are likely to impair compliance with the study protocol and LVAD management\n10. Presence of active, uncontrolled infection\n11. Evidence of intrinsic hepatic disease as defined by liver enzyme values\n12. History of a stroke within 90 days prior to enrollment, or a history of cerebral vascular disease with significant (\\> 80%) extra cranial stenosis\n13. Need for chronic renal replacement therapy (e.g. chronic dialysis)\n14. Participation in any other clinical investigation that is likely to confound study results or affect study outcome\n15. Any condition, other than heart failure, that could limit survival to less than 1 year\n16. Participant refuses to be enrolled in study\n17. Institution inmates.",{"count":227,"type":21},40,[61],"The use of implantable left ventricular assist devices (LVAD) has increased over the last decade; partly because the newer continuous flow pumps feature a smaller design and better durability. These pumps have shown improved outcomes for those patients who don't qualify for heart transplantation and receive the LVAD device as a permanent therapy or a bridge to heart transplantation. Despite these improved outcomes, procedure related length of hospitalization for LVAD implantation is still 2 or 3 times that of other heart surgery treatments. One important reason for this is that many people experience right ventricular dysfunction after LVAD implantation. Treatment options for this are limited. Many LVAD patients with right ventricular dysfunction also have tricuspid valve regurgitation (TR). This is the failure of the tricuspid valve (TV) to close completely so that blood leaks backwards. Some recent studies suggest that correction of the TV during LVAD implantation has improved survival for those with severe regurgitation. However, this has not been evaluated for mild or moderate regurgitation.\n\nThe goal of this study is to look at the clinical impact of surgical correction of mild to moderate TR in participants who are also undergoing LVAD implantation. The study will look at the degree of TR at various time points post-surgery, as well as any major cardiac adverse events, duration of hospitalization, and quality of life. The investigators hope to show that surgical correction of mild to moderate TR in LVAD patients will reduce right ventricular dysfunction and have a positive impact on health outcomes.",[231,29,30],"Tricuspid Regurgitation",[233,234,235,236,237,238,239,240],"LVAD","Tricuspid regurgitation","Heart failure","Transplant","3D transesophageal echocardiography (TEE)","2D transesophageal echocardiography (TEE)","Mild","Moderate","2021-02-19",{"date":243,"type":40},"2021-02-23",{"date":245,"type":4},"2015-08",{"date":247,"type":21},"2026-12",{"name":249,"class":47},"University of Washington"]