[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"end-stage-heart-failure\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:end-stage-heart-failure":23},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,35,64,96],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":4,"briefSummary":21,"conditions":22,"keywords":4,"overallStatus":24,"whyStopped":4,"lastUpdateSubmitDate":25,"lastUpdatePostDateStruct":26,"startDateStruct":29,"completionDateStruct":30,"leadSponsor":32,"locationsCount":4},"100634036","echocardiographic-assessment-of-the-effect-of-impella-on-biventricular-function-100634036",false,"NCT07534462","Echocardiographic Assessment of the Effect of Impella on Biventricular Function","Inclusion Criteria:\n\n1. Adult patients over 18 years old\n2. Require Impella 5.5 implantation\n\nExclusion Criteria:\n\n1. Patients' inability to provide consent for themselves (including that patients' lack of understanding the research)\n2. Any patients who are deemed at higher-than-normal risk for complications secondary to echocardiography, such as dysphagia or esophageal pathology","ALL","18 Years",{"count":18,"type":19},24,"ESTIMATED","OBSERVATIONAL","The objective of this prospective observational study is to evaluate the effects of Impella 5.5 on biventricular function in adult patients with end-stage heart failure requiring temporary mechanical circulatory support. The study will assess changes in left and right ventricular global longitudinal strain and myocardial work, as well as additional echocardiographic and hemodynamic parameters. Measurements will be obtained at baseline prior to Impella implantation, immediately after device initiation, and during postoperative follow-up up to Day 14. This study involves collection of echocardiographic imaging and clinical data, including additional imaging performed for research purposes.",[23],"End-stage Heart Failure","NOT_YET_RECRUITING","2026-06-27",{"date":27,"type":28},"2026-07-01","ACTUAL",{"date":27,"type":19},{"date":31,"type":19},"2027-07-01",{"name":33,"class":34},"University of Rochester","OTHER",{"id":36,"slug":37,"hasResults":11,"nctId":38,"briefTitle":39,"officialTitle":40,"acronym":41,"eligibilityCriteria":42,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":43,"enrollmentInfo":44,"targetDuration":4,"studyType":20,"phases":4,"briefSummary":46,"conditions":47,"keywords":50,"overallStatus":53,"whyStopped":4,"lastUpdateSubmitDate":54,"lastUpdatePostDateStruct":55,"startDateStruct":57,"completionDateStruct":59,"leadSponsor":61,"locationsCount":63},"100411735","noninvasive-cardiovascular-diagnosis-of-patients-with-fully-magnetically-levitated-blood-pumps-100411735","NCT04641416","Noninvasive Cardiovascular Diagnosis of Patients With Fully Magnetically Levitated Blood Pumps","Pilot Study: Noninvasive Cardiovascular Diagnosis of Patients With Fully Magnetically Levitated Blood Pumps","HM3_Snoopy","Inclusion Criteria:\n\nAll patients with the HeartMate 3 system implanted at the Medical University of Vienna, which are able and willing to understand and sign the informed consent form, and which do not meet any exclusion criteria will be included.\n\nExclusion Criteria:\n\n* Age: \\\u003C18 or \\>75 years\n* Inability to provide informed consent\n* Patients with known intraventricular or aortic root thrombus formation or known pathology of the coagulatory system. Although an intraventricular thrombus formation is usually removed intraoperatively during the LVAD implantation procedure, the rationale for this exclusion criterion is to avoid suction of such thrombus material during possible speed changes (± 20% from the initial pump speed). Consequently, the exclusion of patients with known pathology of the coagulation system, who thus have a higher risk of developing any kind of thrombus formation, is another safety measure.\n* Inaccessibility for transthoracic ultrasound diagnostics. Firstly, as described in the visit and assessment schedule (Appendix), changes in pump speed are only performed under transthoracic echo guidance. Secondly, as described above, echo parameters are required to correlate with the non-invasive CDAS pump data. Therefore, the inaccessibility of ultrasound diagnostics (e.g. due to poor image quality) is another exclusion criterion.","75 Years",{"count":45,"type":19},60,"Left Ventricular Assist Device (LVAD) therapy has become a well-established treatment option for endstage heart-failure either as a bridge to transplant (BTT) or destination therapy (DT). Monitoring of the pump and with this the cardiac status with the HeartMate 3 (HM3) is currently very limited to infrequent log-files with one data entry every 15 minutes and only limited amount of entries. Due to the low resolution data, the standard HM3 monitoring is not feasible for the evaluation of suction events or in depth analysis of the interaction between LVAD and the remaining native heart function. Aim of this study is to develop noninvasive diagnostics of the cardiac remaining respectively recovering function derived from HeartMate 3 pump data only and compare with standard clinical diagnostic procedures. These procedures include cardiac ultrasound and ECG. After this pilot study, the newly developed methods would allow frequent, simple and automatic monitoring of patients implanted with the HeartMate 3 device. Such continuous assessment of cardiac function would massively help therapy optimization of cardiac protection and, if possible, cardiac recovery.",[23,48,49],"Cardiomyopathies","Mechanical Circulatory Support",[51,52],"ventricular assist device","non-invasive monitoring","RECRUITING","2026-05-05",{"date":56,"type":28},"2026-05-08",{"date":58,"type":28},"2020-07-09",{"date":60,"type":19},"2026-12-30",{"name":62,"class":34},"Thomas Schlöglhofer, PhD, MSc",1,{"id":65,"slug":66,"hasResults":11,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":70,"eligibilityCriteria":71,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":72,"targetDuration":4,"studyType":74,"phases":75,"briefSummary":77,"conditions":78,"keywords":79,"overallStatus":53,"whyStopped":4,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":95},"100421479","lvad-versus-gdmt-in-ambulatory-advanced-heart-failure-patients-100421479","NCT04768322","LVAD Versus GDMT in Ambulatory Advanced Heart Failure Patients","Left Ventricular Assist Device (LVAD) Versus Guideline Recommended Medical Therapy in Ambulatory Advanced Heart Failure Patients (GDMT)","AMBU-VAD","Inclusion Criteria:\n\n1. All patients ≥18 years,\n2. End-stage heart failure, evaluated by the local Heart Team, defined as:\n\n   * Left ventricular ejection fraction ≤ 35% within 1 week prior to randomization and\n   * Cardiac Index \\\u003C 2.2 L\u002Fmin\u002Fm² by hemodynamic use within 1 month prior to randomization or VO2 max \\\u003C 14 ml\u002Fkg\u002Fmin (or \\\u003C50% of predicted VO2max) within 1 month prior to randomization OR low 6-min walking test (\\\u003C 420 m) within 1 month prior to randomization or ≥ 2 hospitalizations for heart failure in the past year and\n   * NYHA III-IV (INTERMACS profile 4-6) and and\n   * Receiving medical management with optimal doses of betablockers, Angiotensin-Converting-Enzyme-inhibitors or Angiotensin II Receptor Blockers or angiotensin receptor neprilysin inhibitor (if eligible) and Mineralocorticoid Receptor Antagonists and Sodium-GLucose co-Transporter-2 (SGLT2) inhibitors for at least 45 days if tolerated according to guideline at maximal tolerated dose (if maximal HF drug dosage is not reached the investigators will have to explain reason behind not maximal dosage).\n   * Receiving Cardiac Resynchronization Therapy and or Implantable Cardioverter Defibrillators if indicated for at least 45 days and\n   * No mechanical circulatory support or inotrope therapy since \\> 30 days,\n3. Having a health coverage,\n4. Signed written informed consent,\n5. Patient without any legal protection measure.\n\nExclusion Criteria:\n\n1. Inotrope dependent patients or existence of ongoing mechanical circulatory support (MCS) in the last 30 days,\n2. Right ventricular dysfunction (heart team consensus) with the expected need of Bi-VAD support,\n3. Female patients currently pregnant or women of childbearing age who were not using contraception,\n4. Active infection,\n5. Irreversible end-organ dysfunction prior to LVAD implantation,\n6. Contraindication to anti-coagulant or anti-platelet therapies,\n7. History of any organ transplant prior to inclusion,\n8. Psychiatric disease\u002Fdisorder, irreversible cognitive dysfunction or psychosocial issues likely to impair compliance,\n9. Frailty according to heart team,\n10. Platelet count \\\u003C 100,000 x 103\u002Fliter (\\\u003C100,000\u002Fml)\n11. Body Surface Area (BSA) \\\u003C 1.2 m2,\n12. Any condition other than heart failure that could limit survival to less than 24 months,\n13. Chronic renal insufficiency (GFR definitely \\\u003C30 ml\u002Fmin) or hepatic cirrhosis,\n14. Participation in any other interventional clinical investigation.",{"count":73,"type":19},92,"INTERVENTIONAL",[76],"NA","Heart failure is a severe disease affecting approximately 1-2% of the adult population in developed countries and around 26 million people worldwide. Up to 10% of these patients are in advanced stage heart failure, which is defined by a significant morbimortality and considerable medical expenses. Despite advances in its medical management, advanced (or end stage) heart failure is characterized by refractoriness to conventional therapies including guideline-directed pharmacological and non-surgical device treatments. These patients remain severely symptomatic (NYHA IV) and have objective signs of congestion or low cardiac output.\n\nLeft ventricular assist devices (LVADs) have been used in patients with heart failure with reduced ejection fraction for almost 20 years either as an alternative or a bridge to heart transplantation. LVADs improve heart failure symptoms and survival at the cost of increased rates of infection, stroke and bleeding.\n\nDespite the lack of evidence, LVAD implantation in ambulatory patients is not rare, with INTERMACS profiles ≥4 patients representing 15.7% of the overall population implanted between 2012 and 2016.\n\nThe aim of this study is to investigate the efficacy and safety of left ventricular assist devices compared to traditional HF medical treatment alone in a population of ambulatory advanced heart failure patients. Secondary objectives are to better identify subgroups of patients that would benefit the most from the implantation of an LVAD as well as to assess the optimal timing of intervention.",[23],[80,81,82,83,84,85,86],"Heart Failure","End-stage","Not inotrope-dependent","Left Ventricular Assist Device","HeartMate 3 system","Heart Surgery","Guideline Directed Medical Therapy","2026-05-04",{"date":56,"type":28},{"date":90,"type":28},"2021-02-24",{"date":92,"type":19},"2029-02",{"name":94,"class":34},"Hospices Civils de Lyon",8,{"id":97,"slug":98,"hasResults":11,"nctId":99,"briefTitle":100,"officialTitle":101,"acronym":4,"eligibilityCriteria":102,"healthyVolunteers":11,"sex":15,"minAge":4,"maxAge":4,"enrollmentInfo":103,"targetDuration":4,"studyType":20,"phases":4,"briefSummary":105,"conditions":106,"keywords":4,"overallStatus":53,"whyStopped":4,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":63},"100622335","long-term-survival-after-lvad-implantation-in-end-stage-heart-failure-100622335","NCT07382284","Long-Term Survival After LVAD Implantation in End-Stage Heart Failure","Long-Term Survival After Left Ventricular Assist Device Support (LVAD) Implantation in Patients With End-Stage Heart Failure: A Prospective, Observational, Multi-Center Cohort Study","Inclusion Criteria:\n\n1. Adults aged ≥18 years\n2. Diagnosis of end-stage heart failure refractory to optimal medical therapy\n3. Scheduled to undergo left ventricular assist device (LVAD) implantation as part of routine clinical care\n4. Able to provide written informed consent for participation and biospecimen collection\n5. Willing and able to comply with study procedures and long-term follow-up\n6. Availability of left ventricular apical myocardial tissue obtained during LVAD implantation surgery\n7. Availability of peripheral blood samples collected during routine clinical care\n8. Patients treated at participating study centers\n\nExclusion Criteria:\n\n1. Age \\\u003C18 years\n2. Prior implantation of a durable mechanical circulatory support device\n3. Concomitant heart transplantation at the time of index surgery\n4. Congenital heart disease requiring complex surgical repair\n5. Active systemic infection or sepsis at the time of LVAD implantation\n6. Known active malignancy with a life expectancy \\\u003C1 year\n7. Severe non-cardiac comorbidities limiting expected survival to less than 1 year (e.g., advanced liver failure, end-stage renal disease not eligible for renal replacement therapy)\n8. Inability or unwillingness to provide informed consent\n9. Pregnancy or breastfeeding at the time of enrollment\n10. Inadequate quantity or quality of myocardial tissue or peripheral blood samples for planned analyses",{"count":104,"type":19},300,"This is a prospective, observational, multi-center cohort study designed to evaluate long-term survival and clinical outcomes in patients with end-stage heart failure undergoing left ventricular assist device (LVAD) implantation.\n\nPatients receiving LVAD implantation as part of routine clinical care will be enrolled and followed for up to 3-5 years. During the study period, data will be collected on baseline characteristics, preoperative medical therapy, intraoperative surgical information, in-hospital course, and long-term postoperative medication use, as well as survival status, major clinical outcomes, LVAD-related complications, and hospital readmissions.\n\nIn addition, myocardial tissue samples will be obtained from the left ventricular apex during LVAD implantation surgery. These tissue samples are routinely removed as part of the standard surgical procedure and would otherwise be discarded after pathological examination. Peripheral blood samples will also be collected at predefined time points as part of routine clinical blood testing. No additional surgical procedures or invasive interventions are required for this study.\n\nThis study does not involve any experimental treatment or changes to standard medical care. All treatments and follow-up assessments are determined by the treating physicians according to routine clinical practice.\n\nThe purpose of this study is to improve understanding of long-term outcomes after LVAD implantation and to explore potential biological factors associated with prognosis in patients with end-stage heart failure.",[23],"2026-01-25",{"date":109,"type":28},"2026-02-02",{"date":111,"type":28},"2022-07-17",{"date":113,"type":19},"2028-08-01",{"name":115,"class":34},"The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School"]