[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"advanced-heart-failure\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:advanced-heart-failure":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,13,0,[8,46,81,110,148,173,200,226,246,274,298,339,365],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100644241","cardiorenal-syndrome-characteristics-and-prognostic-impact-in-advanced-heart-failure-100644241",false,"NCT07666516","Cardiorenal Syndrome: Characteristics and Prognostic Impact in Advanced Heart Failure","CARAVEL","Inclusion Criteria:\n\n* Written informed consent signed by the patient,\n* Age ≥ 18 years and ≤ 75 years,\n* Patient with advanced heart failure confirmed by criteria of severe cardiac dysfunction documented in a stable condition, with at least one of the following parameters at baseline:\n\n  * LVEF ≤ 35%,\n  * Elevated BNP or NT-proBNP levels (\\>200 ng\u002FL for BNP and \\>1000 ng\u002FL for NT-proBNP),\n* NYHA class ≥ 3,\n* At least one hospitalization for heart failure decompensation within the past 24 months,\n* Optimized medical treatment for heart failure according to French\u002FEuropean cardiology guidelines at the maximum tolerated dose for \\>30 days.\n\nExclusion Criteria:\n\n* Presence of severe extracardiac disease with a life expectancy \\\u003C 1 year,\n* Patient with end-stage renal disease (GFR \\\u003C15 mL\u002Fmin\u002F1.73 m²) or on dialysis,\n* History of heart, kidney, or other solid organ transplantation,\n* Patient in cardiogenic shock,\n* INTERMACS profile ≤ 3,\n* Pregnant, parturient, or breastfeeding women\\*,\n* Individuals deprived of liberty by judicial or administrative decision,\n* Individuals under psychiatric care,\n* Individuals admitted to a health or social institution for purposes other than research,\n* Adults under legal protection (guardianship or curatorship),\n* Individuals not affiliated with a social security system or equivalent coverage.\n* Contraindication to multiparametric renal MRI combined with tissue sodium measurement using non-contrast 23Na MRI of the leg (including inability to undergo MRI as judged by the investigator).","ALL","18 Years","75 Years",{"count":20,"type":21},100,"ESTIMATED","INTERVENTIONAL",[24],"NA","Advanced heart failure (AHF) represents the end stage of chronic heart failure with reduced ejection fraction and affects up to 10% of patients with heart failure. These patients have refractory disease despite optimal guideline-directed medical therapy, and their management is discussed within a multidisciplinary \"Heart Team\".\n\nRenal dysfunction is highly prevalent in this population. The coexistence of cardiac and renal dysfunction has been classified under the entity of cardiorenal syndrome. Impaired renal function is an independent predictor of adverse cardiovascular and renal outcomes, including death, heart failure decompensation, worsening renal function, and the need for renal replacement therapy. However, patients with AHF remain a particularly complex population, and the lack of longitudinal biological data and limited understanding of the dynamics of cardiorenal syndrome in relation to therapeutic interventions make prognosis assessment and individualized management challenging.\n\nIn addition, little is known about renal tubular function in AHF, despite its central role in hydro-electrolytic balance regulation. Biomarkers of tubular injury such as neutrophil gelatinase-associated lipocalin (NGAL) and kidney injury molecule-1 (KIM-1) have shown prognostic value in therapeutic studies, but their relationship with cardiac function and outcomes in advanced heart failure remains insufficiently characterized.\n\nThe primary objective of this study is to evaluate renal function parameters and their evolution over time through measurement of glomerular filtration rate (GFR) and assessment of tubular function in patients with advanced heart failure, and to investigate their association with major adverse cardiovascular events.\n\nThis is a prospective, single-center RIPH2 cohort study including 100 patients aged 18 to 75 years managed for advanced heart failure at the Louis Pradel Cardiovascular Hospital (Hospices Civils de Lyon, France). Patients will be followed according to standard care at 6, 12, 18, and 24 months. More comprehensive nephrological and cardiological evaluations will be performed at baseline, 12 months, and 24 months. Biobanking and quality-of-life questionnaires will also be conducted during these visits. Blood and urine samples will be collected at baseline and 12 months for NGAL et KIM-1 analysis. In addition, a subgroup of 50 consenting patients without contraindications will undergo multiparametric non-contrast renal MRI combined with tissue sodium quantification using 23Na MRI of the leg.",[27,28],"Advanced Heart Failure","Cardiorenal Syndrome",[30,31,32],"advanced heart failure","cardiorenal syndrome","biomarkers","NOT_YET_RECRUITING","2026-06-29",{"date":36,"type":37},"2026-07-01","ACTUAL",{"date":39,"type":21},"2026-09-01",{"date":41,"type":21},"2031-11-15",{"name":43,"class":44},"Hospices Civils de Lyon","OTHER",1,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":53,"targetDuration":4,"studyType":22,"phases":55,"briefSummary":58,"conditions":59,"keywords":61,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":45},"100643103","phase-1-hicm-188-cell-therapy-in-adults-with-advanced-heart-failure-undergoing-heart-bypass-surgery-100643103","NCT07646210","HiCM-188 Cell Therapy in Adults With Advanced Heart Failure Undergoing Heart Bypass Surgery","A Phase I\u002FIIa, Open-Label, Dose Escalation Study to Evaluate the Safety and Tolerability of HiCM-188, an Allogeneic iPSC-derived Cardiomyocyte Therapy, in Adult Patients With Advanced Heart Failure","Inclusion Criteria:\n\n* Able to sign informed consent and comply with the study protocol\n* 18 to 75 years old at the time of signing informed consent\n* Advanced heart failure patients with New York Heart Association (NYHA) class III to IVa despite receiving guideline-directed medical therapy (GDMT)\n* Patients with an indication for coronary artery bypass grafting (CABG) per 2011 ACCF\u002FAHA Guideline meeting a Class of Recommendation (COR) of Class I or Class IIa\n* Minimum left ventricular wall thickness of ≥ 8 mm in the areas of injection, as confirmed on the screening echocardiogram (ECHO) or cardiac MRI\n* Left ventricular ejection fraction (LVEF) of 20% to 45%, as confirmed on the screening echocardiogram (ECHO) or cardiac MRI\n* Other criteria apply. Please contact the investigator for more information.\n\nExclusion Criteria:\n\n* Viral myocarditis\n* Amyloidosis\n* Pericardial disorders or pericarditis\n* Left ventricular aneurysm or thrombus, except a small laminar thrombus at the site of previous myocardial infarction (MI) in a different area\n* Primary significant organic valvular heart disease, with specified dimensions\n* Untreated congenital heart disease\n* Complete atrioventricular (AV) conduction block\n* History of left ventricular assist device surgery\n* Other criteria apply. Please contact the investigator for more information.",{"count":54,"type":21},12,[56,57],"PHASE1","PHASE2","This clinical study will evaluate the safety and tolerability of HiCM-188, an investigational allogeneic induced pluripotent stem cell (iPSC)-derived cardiomyocyte therapy, in adults with advanced heart failure who are undergoing coronary artery bypass grafting (CABG) surgery.\n\nParticipants who meet the study eligibility criteria will receive a single dose intramyocardial injection of HiCM-188 during CABG surgery. The study will evaluate two dose levels of HiCM-188 using an open-label dose-escalation design. Participants will be followed for up to 12 months after treatment to monitor safety and preliminary signs of clinical effect.",[27,60],"Ischemic Heart Failure",[62,63,64,65,66,67,68,69,70,71],"HiCM-188","iPSC-derived cardiomyocytes","Allogeneic cell therapy","Advanced heart failure","Ischemic heart failure","Intramyocardial injection","Coronary artery bypass grafting","CABG","Dose escalation","NYHA Class III-IVa","2026-06-25",{"date":34,"type":37},{"date":75,"type":21},"2026-09",{"date":77,"type":21},"2028-05",{"name":79,"class":80},"HELP Therapeutics Co., Ltd.","INDUSTRY",{"id":82,"slug":83,"hasResults":11,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":87,"eligibilityCriteria":88,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":89,"enrollmentInfo":90,"targetDuration":4,"studyType":22,"phases":92,"briefSummary":93,"conditions":94,"keywords":95,"overallStatus":99,"whyStopped":4,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":109},"100643582","first-in-human-study-of-the-icoms-flowmaker-100643582","NCT07632586","First in Human Study of the Icoms Flowmaker","A Prospective, Single Arm, Multicentric, First in Human Study to Evaluate the Safety and Performance at 30 Days of the FineHeart Icoms® FlowMaker® in Subjects With Advanced Heart Failure.","FAIR","Inclusion Criteria:\n\n* 1- Age 18 and 80 years included.\n* 2- Written inform consent.\n* 3- Females of child-bearing age must agree to use adequate contraception.\n* 4- Suitable neurocognitive status.\n* 5- Distance between the aortic valve and the LV endocardial apex ≥ 95mm and the Left Ventricular (LV) volume \\> 200 mL\n* 6- Body Surface Area (BSA) ≥ 1.2 m².\n* 7- LVEF ≤ 35 % and assessed Intermacs ≤ 4\n* 8- Advanced heart failure patients symptomatic despite optimal medical management (OMM) based on the European Cardiology Society guidelines15 otherwise meeting standard best practice indications for implantable LVAD\n\nAND fulfilling at least one of the following criteria approved by the International multidisciplinary expert selection committee:\n\n• 9- Contraindication or excessively heightened risk of a conventional LVAD implant due to factors such as:\n\n* CVP\u002FPCWP ≤ 0.6\n* anatomical or surgical factors constituting excessive\n* perioperative implant risks.\n* (Duly recorded in the source document during the patient Inform\n* consent process)\n\nOR\n\n* 10- Patient with high risk of percutaneous driveline-induced morbidity such as:\n\n  * patient with recurrent infections \u002F severe diabetes mellitus \u002F immunodeficiency \u002F cachexia\n  * psychological factors limiting percutaneous driveline\n  * acceptance and \u002F or management duly recorded in the Psychological evaluation report at screening.\n* 11- Temporary ineligibility to heart transplant(active or remission of cancer \u002F highly sensitized PRA…) Duly recorded in the source document during the patient Inform consent process.\n* 12- Patient's affiliation to health care insurance, if local requirement\n* 13- Patient implanted with a cardioverter defibrillator from Medtronic and Boston or patient requiring implantation of a cardiac defibrillator due to a risk of ventricular arrhythmia\n\nExclusion Criteria:\n\n* 1-Body Mass Index (BMI) \\> 40.\n* 2- TAPSE ≤10 mm\n* 3- Pulmonary VTI ≤ 6cm\n* 4- Patients not eligible to transplant due to surgical risks\n* 5- Existence of any ongoing mechanical circulatory support (MCS) other than an intra-aortic balloon pump (IABP)\n* 6- History of left thoracotomy.\n* 7- History of confirmed untreated abdominal or thoracic aortic aneurysm \\> 5 cm.\n* 8- Cardiothoracic surgery within 30 days of implant.\n* 9- Acute myocardial infarction within 14 days of implant.\n* 10- On ventilator support for \\> 72 hours within the four days immediately prior to implant.\n* 11- Pulmonary embolus within three weeks of implant.\n* 12- Presence of current atrial or ventricular thrombus, confirmed by MRI, CT-SCAN or Trans-Esophageal Echocardiography.\n* 13- Symptomatic cerebrovascular disease, stroke within 180 days of screening or \\> 80% stenosis of carotid, vertebral or cranial vessels.\n* 14- Moderate to severe aortic regurgitation, defined as \\> 50% regurgitant fraction.\n* 15- Moderate - Severe aortic stenosis, defined as an aortic valve area (AVA) ≤ 1.5 cm2.\n* 16- Active, uncontrolled infections, history of hyperleukocytosis with Leucocytes \\> 10.000\u002Fmm3, CRP 17- 10mg\u002Fl, PCT \\> 0,2ng\u002Fml, positive hemocultures \\\u003C 48 hours, positive urine cultures, positive sputum cultures, any abnormalities identified by CT scan of brain-thorax and abdomino-pelvic region.\n* 17- Uncorrected thrombocytopenia or generalized coagulopathy (e.g., platelet count \\\u003C 100,000 \u002F INR \\> 2.0 in the absence of anticoagulation therapy).\n* 18- Hepatic insufficiency: a total bilirubin \\> 3 mg\u002FdL within 72 hours before implant, or biopsy proven liver cirrhosis or portal hypertension.\n* 19- Pulmonary vascular resistance (PVR) demonstrated to be unresponsive to pharmacological manipulation and the PVR \\> 6 Wood units.\n* 20- Patients with a mechanical heart valve.\n* 21- Etiology of heart failure due to, or associated with, uncorrected thyroid disease, obstructive cardiomyopathy, pericardial disease, amyloidosis, active myocarditis, or restrictive cardiomyopathy, ventricular septal defect\n* 22- History of severe Chronic Obstructive Pulmonary Disease (COPD) or severe restrictive lung disease. GOLD (Global Initiative for Chronic Obstructive Lung Disease) score \\\u003C 3.\n* 23- Participation in any other study involving investigational drugs, devices, or biologics.\n* 24- Severe illness, other than heart disease, which would limit survival to a maximum of 1 year.\n* 25- Peripheral vascular disease with rest pain or ischemic ulcers of the extremities.\n* 26- Pregnancy.\n* 27- Patient unwilling or unable to comply with study requirements.\n* 28- Patients unable or unwilling to sign the written informed consent.\n* 29- Technical obstacles, which pose an inordinately high surgical risk, in the judgment of the investigator.\n* 30- Intolerance to anticoagulant or antiplatelet therapies or any other peri- or postoperative therapy that the investigator may administer based upon the patient's health status.\n* 31- Specific liver enzymes \\[AST (SGOT) and ALT (SGPT)\\] 3 times upper limit of normal within 72 hours before implant.\n* 32- Patient living alone (without an accompanying person).\n* 33- Rapid AF, unless nodo-hissian junction ablation is considered.\n* 34- Mid-septal end-systolic LV diameter ≤ 25mm\n* 35- Sequential Organ Failure Assessment Score (SOFA score \\> 8)\n* 36- Minor subjects, persons deprived of liberty, protected adults, or those unable to consent\n* 37- Subjects who have participated in a clinical trial within 12 months\n* 38- Patient implanted with an Implantable Cardioverter Defibrillator (ICD) other than Medtronic and Boston.","80 Years",{"count":91,"type":21},10,[24],"The Icoms® FlowMaker® is a cardiac assist system in the true sense of the word. As assisting means to help or rescue, its function is providing assistance to the heart, which will continue to have its own hemodynamic pump function. The effect of the Icoms® FlowMaker® is to add an additional quantity of blood flow on top of the native blood flow, during each systole. The heart continues to have its own contribution, but a more satisfactory blood flow is restored by the complementary action of the Icoms® FlowMaker® This study is a first in human test to evaluate the safety and the performance of the Icoms Flowmaker. The study population consists of patients with severe heart failure who are at high risk for a conventional LVAD and at high risk for a percutaneous driveline. Ten patients will be recruited and implanted In France , Slovenia and Czech republic.\n\nThe study objectives are:\n\no evaluate the safety and performance of the Icoms® FlowMaker® implantable device in patients with severe heart failure resistant to optimal medical therapy.\n\n--Primary Objective: Assess safety and performance of the device at 30 days post-implantation.\n\nSecondary Objectives: Evaluate the patient's hemodynamic and clinical status, and the device's functionality per technical specifications.",[27],[96,97,98],"Severe heart failure","wireless implantable cardiac device","Icoms Flowmaker","RECRUITING","2026-06-02",{"date":102,"type":37},"2026-06-08",{"date":104,"type":37},"2023-12-19",{"date":106,"type":21},"2029-12",{"name":108,"class":80},"FineHeart",2,{"id":111,"slug":112,"hasResults":11,"nctId":113,"briefTitle":114,"officialTitle":115,"acronym":116,"eligibilityCriteria":117,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":118,"targetDuration":4,"studyType":22,"phases":120,"briefSummary":121,"conditions":122,"keywords":136,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":139,"lastUpdatePostDateStruct":140,"startDateStruct":142,"completionDateStruct":144,"leadSponsor":146,"locationsCount":91},"100640479","reaction-vad-trial-remote-exercise-training-via-telemedicine-in-patients-with-long-term-ventricular-assist-devices-100640479","NCT07611188","REACTION-VAD Trial: Remote Exercise Training Via Telemedicine in Patients With Long-Term Ventricular Assist Devices","Efficacy and Safety of a Remote Conditioning Program in Patients Supported With a Ventricular Assist Device: THE RE-ACTION-VAD TRIAL.","REACTION-VAD","Inclusion Criteria (must meet all):\n\n* Recent LVAD Implantation (\\\u003C6 months)\n* Clinical stability (defined as meeting all of the following criteria): discharge from the LVAD implantation hospitalization, absence of inotropic medication, hemoglobin \\>9 g\u002FdL, and no active infection.\n* Inability to participate in a supervised rehabilitation program (due to lack of availability, or inability because geographical reasons).\n\nExclusion Criteria (any):\n\n* Functional Inability to Perform Cardiopulmonary Exercise Testing\n* Prior Participation in a Supervised Rehabilitation Program (after the LVAD implantation)",{"count":119,"type":21},78,[24],"Current international guidelines recommend that patients with a heart pump (left ventricular assist device, LVAD) participate in supervised exercise cardiac rehabilitation programs. However, not all patients with a heart pump are able to attend to a supervised program on a daily basis.\n\nThe goal of this clinical trial is to determine whether a home-based exercise program helps patients with a heart pump improve their exercise capacity and quality of life, guided by telemedicine tools including a mobile app, smartwatch, and remote medical checkups. The study will also provide information about the safety of this program by monitoring for any issues or symptoms during home activity.\n\nThe trial aims to answer the following questions:\n\n* Does a 12-week remote exercise program improve patients' exercise capacity? This will be measured using the 6-minute walk test and a cardiopulmonary exercise test.\n* Is it safe for patients to follow this exercise plan at home while being monitored through a mobile app and smartwatch?\n* Does the program improve quality of life and reduce feelings of anxiety or depression? This will be assessed using widely validated questionnaires, such as the Kansas City Cardiomyopathy Questionnaire.\n\nResearchers will compare the remote exercise program to standard care, which usually does not include exercise for patients who are unable to attend the hospital daily.\n\nParticipants will:\n\n* Join the study voluntarily after signing a consent form.\n* Be randomly assigned, with a 50% chance of being in either the exercise group (following a structured plan with a mobile app) or the usual care group (receiving general written advice), to see which approach works best for recovery.\n* Follow a 12-week home-based routine if in the exercise group, including warm-up routine, walking or cycling, respiratory exercises, and light strength training, all supported by the mobile app, smartwatch, and professional monitoring.\n* Visit the hospital three times over six months for medical checkups, including walking and exercise tests, blood analyses, and questionnaires about physical and emotional health.",[123,27,124,125,126,127,128,129,130,131,132,133,134,135],"Heart Failure","Left Ventricular Assist Device","LVAD","Cardiac Rehabilitation","Telemedicine","Remote Exercise","Ventricular Assist Device","Exercise Training","Conditioning Therapy","Cardiopulmonary Exercise Test","Six Minute Walk Test","Quality of Life","Telerehabilitation",[124,27,123,126,137,127,138,134,132,135],"Remote rehabilitation","6 minute walking test","2026-05-20",{"date":141,"type":37},"2026-05-28",{"date":143,"type":21},"2026-05",{"date":145,"type":21},"2030-12",{"name":147,"class":44},"Puerta de Hierro University Hospital",{"id":149,"slug":150,"hasResults":11,"nctId":151,"briefTitle":152,"officialTitle":153,"acronym":4,"eligibilityCriteria":154,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":155,"targetDuration":4,"studyType":22,"phases":157,"briefSummary":158,"conditions":159,"keywords":160,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":164,"lastUpdatePostDateStruct":165,"startDateStruct":167,"completionDateStruct":169,"leadSponsor":171,"locationsCount":45},"100610922","duocor-2-dominate-study-100610922","NCT07233876","DuoCor 2 DOMINATE Study","A Prospective, Multi-Center, Single-Arm Study for the Evaluation of the DuOCor 2 Ventricular Assist SysteM In Patients With AdvaNced BIventriCulAr HearT FailurE","Inclusion Criteria:\n\n* 1\\. Age ≥ 18 years and ≤ 75 years\n* 2\\. Patient is inotrope dependent, OR has a Cardiac Index (CI) \\\u003C 2.2 L\u002Fmin\u002Fm2, while not on inotropes\n* 3\\. Patient has left heart failure with at least one of the following criteria:\n* Left ventricular ejection fiction (LVEF) ≤ 30%;\n* Pulmonary capillary wedge pressure (PCWP) \\> 15mmHg.\n* 4\\. Patient has severe, irreversible biventricular heart failure and is eligible for biventricular mechanical circulatory support based on the ISHLT guideline. This includes at least two of the following hemodynamic and\u002For echocardiographic measurements:\n* Right ventricular ejection fraction (RVEF)≤ 30%;\n* Right ventricular stroke work index (RVSWI)≤ 0.25 mmHg\\*L\u002Fm2;\n* Tricuspid annular plane systolic excursion (TAPSE)≤ 14 mm;\n* Right ventricular (RV) to left ventricular (LV) end-diastolic diameter ratio\\> 0.72;\n* Central venous pressure (CVP)\\> 15 mmHg;\n* CVP to PCWP ratio\\> 0.63;\n* Tricuspid insufficiency grade 2-4;\n* Pulmonary artery pressure index (PAPi)\\\u003C 2;\n* 5\\. Patient or its legal representative has signed the informed consent, has full understanding of procedures and the study, and is committed to following study requirements.\n\nExclusion Criteria:\n\n* 1\\. Known intolerance to anticoagulant or antiplatelet therapies.\n* 2\\. Etiology of heart failure due to restrictive or constrictive physiology (e.g., hypertrophic cardiomyopathy, cardiac amyloidosis \u002Fsenile or other infiltrative heart disease).\n* 3\\. Coagulopathy defined by platelets \\\u003C 100k\u002Fµl or INR ≥ 1.5 not due to anticoagulant therapy.\n* 4\\. Technical obstacles which pose an inordinately high surgical risk, in the judgment of the investigator.\n* 5\\. Presence of temporary mechanical circulatory support such as Impella (all types) or IABP with a duration greater than 21 days.\n* 6\\. Presence of ECMO with a duration greater than 10 days.\n* 7\\. Patient is implanted with durable mechanical circulatory support (LVAD or RVAD) and has refused to switch to the study device.\n* 8\\. Patient experienced cerebrovascular accident (CVA) within 3 months of eligibility evaluation.\n* 9\\. Presence of any one of the following risk factors for indications of severe end organ dysfunction or failure:\n* Total bilirubin \\> 3.0 mg\u002FdL or cirrhosis confirmed by imaging or positive biopsy;\n* Glomerular filtration rate (GFR) \\\u003C 30 mL\u002Fmin\u002F1.73 m2 or renal replacement therapy dependence;\n* History of severe chronic obstructive pulmonary disease (COPD) defined by FEV1\u002FFVC \\\u003C 0.7, or FEV1 \\\u003C 50% predicted.\n* Significant peripheral vascular disease (PVD) accompanied by rest pain or extremity ulceration;\n* 10\\. Fixed pulmonary hypertension with a most recent PVR ≥ 8 Wood units.\n* 11\\. Severe systemic light-chain amyloidosis.\n* 12\\. Blood stream infection within seven days. Positive blood cultures reflective of contaminants (e.g., Staphylococcus epidermidis) will not be considered an exclusion.\n* 13\\. Sepsis\n* 14\\. History of confirmed, untreated abdominal aortic aneurysm (AAA) or thoracic aortic aneurysm (TAA) \\> 5 cm in diameter.\n* 15\\. Any condition other than HF that could limit survival to less than 24 months.\n* 16\\. Positive pregnancy test if of childbearing potential.\n* 17\\. Lactating mothers.\n* 18\\. Participation in any other clinical investigation that is likely to confound study results or affect the study.",{"count":156,"type":21},50,[24],"Advanced heart failure is a life-threatening condition characterized by the inability of one or both ventricles to maintain adequate blood circulation. In such cases, medical treatments often prove ineffective, necessitating advanced treatment. Heart transplantation is the standard treatment for these patients, but it is severely limited by the shortage of donor hearts. As a result, mechanical circulatory support (MCS) devices are often employed. However, the most common form, the left ventricular assist device (LVAD), is only suitable for patients with isolated left ventricular dysfunction. This leaves a significant treatment gap for patients with biventricular failure. For this population, current options, such as total artificial hearts (TAHs) and biventricular assist devices (BiVADs), are associated with significant challenges, including high rates of adverse events and suboptimal long-term outcomes.\n\nThe DuoCor Ventricular Assist System (VAS) is a next-generation MCS device specifically developed to address this need by providing simultaneous biventricular support. It incorporates two compact, good hemocompatible blood pumps designed for implantation in both the left and right heart, controlled via a single driveline and external controller. It aims to reduce surgical complexity, improve patient mobility, and minimize complications such as thrombosis and infection.\n\nThe primary objective of this study is to evaluate the safety and efficacy of the DuoCor VAS as a treatment for advanced biventricular heart failure.",[27],[161,162,163],"Mechanical Circulatory Support","Biventricular Heart Failure","Biventricular Assist Device","2026-04-21",{"date":166,"type":37},"2026-04-24",{"date":168,"type":21},"2026-04-01",{"date":170,"type":21},"2029-04-01",{"name":172,"class":80},"Shenzhen Core Medical Technology CO.,LTD.",{"id":174,"slug":175,"hasResults":11,"nctId":176,"briefTitle":177,"officialTitle":178,"acronym":179,"eligibilityCriteria":180,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":181,"targetDuration":4,"studyType":183,"phases":4,"briefSummary":184,"conditions":185,"keywords":187,"overallStatus":99,"whyStopped":4,"lastUpdateSubmitDate":191,"lastUpdatePostDateStruct":192,"startDateStruct":194,"completionDateStruct":196,"leadSponsor":198,"locationsCount":45},"100631179","gdf-15-and-early-outcomes-after-lvad-implantation-100631179","NCT07497308","GDF-15 and Early Outcomes After LVAD Implantation","Association of Preoperative GDF-15 Levels With Early Postoperative Outcomes and Mortality After LVAD Implantation","LVAD-GDF15","Inclusion Criteria:Adults aged 18 years and older\n\nPatients with advanced heart failure undergoing LVAD implantation\n\nAvailability of preoperative GDF-15 measurement\n\nAbility to provide written informed consent or consent provided by a legally authorized representative, according to local regulations -\n\nExclusion Criteria:Age under 18 years\n\nActive infection\n\nActive malignancy\n\nSevere hepatic failure\n\nMissing study data\n\nRefusal to participate\n\n\\-",{"count":182,"type":21},48,"OBSERVATIONAL","This observational study aims to investigate the association between preoperative GDF-15 levels and early postoperative outcomes in patients undergoing left ventricular assist device (LVAD) implantation. The study will evaluate whether elevated preoperative GDF-15 levels are associated with adverse early outcomes, including postoperative complications and mortality. The findings may help improve preoperative risk assessment and identify high-risk patients before LVAD implantation.",[27,186],"Left Ventricular Assist Device Implantation",[124,188,189,190],"GDF-15","Postoperative Outcomes","Early Mortality","2026-03-24",{"date":193,"type":37},"2026-03-27",{"date":195,"type":37},"2026-02-04",{"date":197,"type":21},"2026-12-23",{"name":199,"class":44},"Akdeniz University",{"id":201,"slug":202,"hasResults":11,"nctId":203,"briefTitle":204,"officialTitle":205,"acronym":206,"eligibilityCriteria":207,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":208,"targetDuration":4,"studyType":22,"phases":210,"briefSummary":211,"conditions":212,"keywords":214,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":217,"lastUpdatePostDateStruct":218,"startDateStruct":220,"completionDateStruct":222,"leadSponsor":224,"locationsCount":109},"100627230","palliative-care-intervention-to-improve-health-related-quality-of-life-for-patients-on-long-term-lvad-support-100627230","NCT07445932","Palliative Care Intervention to Improve Health Related Quality of Life for Patients on Long-Term LVAD Support","The PALL-VAD Study: Palliative Care Intervention to Improve Health Related Quality of Life for Patients With Heart Failure on Long-Term LVAD Support: A Pilot, Prospective, Randomized Trial","PALL-VAD","Inclusion Criteria:\n\n* LVAD patients \\>= 18 years of age\n* \\>= 1 year post-LVAD implantation\n\nExclusion Criteria:\n\n* Listed for heart transplantation. Undergoing evaluation for heart transplantation, however, is not an exclusion.\n* Non-English speaking\n* Receiving outpatient palliative care in the last 6 months\n* Renal replacement therapy\n* Non-cardiac terminal illness\n* Women who are pregnant or planning to become pregnant\n* Inability to comply with study protocol and follow up\n* Inabilty to provide consent.\n* Cognitive impairment or intellectual disability that prohibits successful completion of the HRQoL scales or compliance with the study protocol and follow up.",{"count":209,"type":21},90,[24],"Background: While left ventricular assist device (LVAD) therapy improves survival in patients with advanced heart failure (AHF), unique LVAD-related burdens may impact health-related quality of life (HRQoL). Palliative care specialists are key members of the multidisciplinary care team for patients with long-term-LVAD (LT-LVAD), offering specialized, comprehensive, holistic care.\n\nProblem: A seminal study of palliative care in patients with heart failure (PAL-HF trial) demonstrated that outpatient palliative care improved HRQoL, depression, anxiety, and spiritual well-being compared to usual care. The impact of longitudinal palliative care on HRQoL in LT-LVAD patients is unknown.\n\nObjective: The investigators aim to conduct the first study examining a palliative care intervention to improve HRQoL among LT- LVAD recipients (patients who have lived with LT-LVAD for at least six months and are not heart transplant candidates) at two centers (MedStar Health and Inova) in the Mid-Atlantic Region. Given the demographics of the study institutions, the investigators anticipate a socioeconomically and racially diverse cohort of patients with subgroups who may disproportionately experience LVAD-related burdens relative to benefits.\n\nAims: The first aim is to assess baseline measures of HRQoL in LT-LVAD patients to understand differences in HRQoL across subgroups and multiple, understudied domains. The second aim is to test the feasibility and acceptability of a randomized, unblinded pilot study of a palliative care interdisciplinary intervention in this population.\n\nSignificance: Results of this study will inform the development of a large randomized controlled trial to test the effectiveness of palliative care intervention in improving HRQoL in LT-LVAD patients. If results are positive, this will revolutionize the post-LVAD treatment paradigm, by making palliative care integration the standard of care for longitudinal LT-LVAD patient management.",[27,161,124,213],"Palliative Care",[30,215,216],"left ventricular assist device","palliative care","2026-02-25",{"date":219,"type":37},"2026-03-03",{"date":221,"type":21},"2026-03-01",{"date":223,"type":21},"2027-03-01",{"name":225,"class":44},"Medstar Health Research Institute",{"id":227,"slug":228,"hasResults":11,"nctId":229,"briefTitle":230,"officialTitle":231,"acronym":4,"eligibilityCriteria":232,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":233,"targetDuration":4,"studyType":22,"phases":235,"briefSummary":236,"conditions":237,"keywords":4,"overallStatus":99,"whyStopped":4,"lastUpdateSubmitDate":238,"lastUpdatePostDateStruct":239,"startDateStruct":241,"completionDateStruct":243,"leadSponsor":244,"locationsCount":109},"100585795","corwave-lvas-fih-study-100585795","NCT06907017","CorWave LVAS FIH Study","First In Human Clinical Study of the CorWave Left Ventricular Assist System for the Treatment of Patients With Advanced Heart Failure","Inclusion Criteria:\n\n* Subject or legal representative has signed Informed Consent Form\n* Age \\> 18 and \\\u003C 75 years old\n* Body Surface Area (BSA) ≥ 1.2 m2\n* Left Ventricular Ejection Fraction (LVEF) ≤ 35%\n* Inotrope dependent OR\n* Cardiac Index (CI) \\\u003C 2.2 L\u002Fmin\u002Fm2, while not on inotropes and subjects must also meet one of the following criteria:\n\n  * On Guideline Directed Medical Therapy (GDMT) for at least 45 out of the last 60 days and are failing to respond.\n  * Advanced heart failure (Class III or Class IV for at least 14 days AND support from short term mechanical circulatory support for up to 7 days).\n* Females of childbearing age must agree to use adequate contraception.\n* Patient must be eligible for heart transplantation.\n\nExclusion Criteria:\n\n* Heart failure (HF) due to or associated with uncorrected thyroid disease, obstructive cardiomyopathy, pericardial disease, amyloidosis or restrictive cardiomyopathy.\n* Technical obstacles which pose an inordinately high surgical risk, in the judgment of the Investigator\n* Ongoing mechanical circulatory support (MCS) other than IABP or micro axial pumps\n* INTERMACS Class I patients\n* Subject is on a ventilator\n* Subject is pregnant or breastfeeding\n* Presence of a mechanical aortic valve that will not be converted to a bioprosthesis at the time of LVAD implant\n* History of any organ transplant\n* Platelet count \\\u003C 100,000\u002Fμl\n* Psychiatric disease\u002Fdisorder, illicit drug use, irreversible cognitive dysfunction or psychosocial issues that are likely to impair compliance with the study protocol and LVAD management\n* History of confirmed untreated abdominal aortic aneurysm (AAA) \\> 5 cm in diameter within 6 months of enrollment\n* Presence of an active, uncontrolled infection\n* Intolerance to anticoagulant or antiplatelet therapies or any other peri\u002Fpost-operative therapy the investigator will require based upon the patient's health status\n* Presence of any one of the following risk factors for indications of severe end organ dysfunction or failure:\n* An INR ≥ 2.0 not due to anticoagulation therapy\n* Total bilirubin \\> 43 µmol\u002FL (2.5 mg\u002FdL), liver function tests greater than 3 times the establish laboratory normal, including Serum Albumin below 3.5 g\u002Fdl, shock liver, or biopsy proven liver cirrhosis\n* History of severe chronic obstructive pulmonary disease (COPD) and restrictive disease (fibrosis); FEV1 \\\u003C 50%, a total FEV1 below 1000 mL and a DLCO \\\u003C 50% predicted.\n* Fixed pulmonary hypertension with a most recent PVR ≥ 8 Wood units that is unresponsive to pharmacologic intervention\n* History of stroke within 90 days prior to enrollment, or a history of cerebrovascular disease with significant (\\> 50%) uncorrected carotid stenosis\n* Serum creatinine ≥ 221 µmol\u002FL (2.5 mg\u002FdL) or the need for chronic renal replacement therapy.\n* Ongoing patient malnutrition evidenced by nonintentional weight loss of greater than 5% of body mass in the previous 30 days, prealbumin \\\u003C 16 mg\u002FdL, or Mini Nutritional Assessment score \\\u003C 17.\n* Poorly controlled diabetes mellitus or a hemoglobin A1c \\> 8.5%.\n* Significant peripheral vascular disease (PVD) accompanied by rest pain or extremity ulceration.\n* Patient has severe aortic insufficiency without plans for correction during pump implant.\n* Planned Bi-VAD support prior to enrollment.\n* Patient has known hypo or hyper coagulable states such as disseminated intravascular coagulation and heparin induced thrombocytopenia.\n* Participation in any other clinical investigation that is likely to confound study results or affect the study.\n* Any condition other than HF that could limit survival to less than 12 months.\n* Acute myocardial infarction within 14 days of implant as diagnosed by ST elevation (STEMI) changes on ECG, diagnostic biomarkers, and hemodynamic abnormalities. Planned or carried out coronary revascularizations (including PCI requiring (dual) antiplatelet therapies).\n* Pulmonary embolus within 6 weeks of implant as documented by computed tomography (CT) scan or nuclear scan.\n* Subject is unwilling or unable to comply with trial requirements.",{"count":234,"type":21},20,[24],"The study is a prospective, multi-center, non-randomized trial to evaluate the safety and effectiveness of the CorWave LVAS for the treatment of advanced heart failure patients.",[27],"2026-02-06",{"date":240,"type":37},"2026-02-09",{"date":242,"type":37},"2025-05-06",{"date":77,"type":21},{"name":245,"class":80},"CorWave",{"id":247,"slug":248,"hasResults":11,"nctId":249,"briefTitle":250,"officialTitle":251,"acronym":252,"eligibilityCriteria":253,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":254,"targetDuration":4,"studyType":22,"phases":256,"briefSummary":257,"conditions":258,"keywords":262,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":265,"lastUpdatePostDateStruct":266,"startDateStruct":267,"completionDateStruct":269,"leadSponsor":271,"locationsCount":273},"100623078","tier-palliative-care-for-patients-with-advanced-heart-failure-or-cancer-100623078","NCT07391956","Tier Palliative Care For Patients With Advanced Heart Failure or Cancer","TIER-PALLIATIVE CARE: A Population-based Care Delivery Model to Match Evolving Patient Needs and Palliative Care Services for Community-based Patients With Heart Failure or Cancer","TIER-PC","Inclusion Criteria:\n\n* Advanced Heart Failure (HF) with two HF-related hospitalizations within the last 12 months or\n* Advanced lung or non-colorectal gastrointestinal cancer (pancreatic, gastric, hepatobiliary, small bowel, esophageal) or tripe negative breast cancer with one hospitalization within the last 6 months\n* KPS \\> or = 50% (ECOG 0, 1 or 2)\n* \\> 2 outpatient MSHS visits in prior 12 months\n* Manhattan or Queens residence\n* Capacity to provide informed consent\n* English or Spanish fluency\n* \\> or = 18 years of age\n\nExclusion Criteria:\n\n* Diagnoses of both cancer and advanced HF\n* Lung cancer with a driver mutation (e.g., EGFR) that confers a favorable prognosis and does not follow typical trajectory\n* Patients with \\> 1 visit to Outpatient Supportive Oncology\u002FCardiology visit\n* Patients with last visit to Outpatient Supportive Oncology\u002FCardiology \\\u003C 3 months ago\n* Previous receipt of a ventricular assist device or previous heart transplantation\n* Receiving hospice care prior to study enrollment or enrolled in another study of a palliative care patient\u002Fcaregiver intervention\n* Living in a facility (subacute rehab, long-term care facility, hospice facility or residence)\n* Callahan 6-Item Cognitive Screening score ≤3",{"count":255,"type":21},400,[24],"TIER-PC is an adaptive model of delivering palliative care that provides the right level of care to the right patients at the right time. It represents an adaption of the Mount Sinai PALLIATIVE CARE AT HOME (PC@H) program, which delivers home-based palliative care. TIER-PC increases the number and intensity of disciplines added to the patient's care team as their symptoms worsen and function declines. In Tier 1, patients who are able to care for themselves and no\u002Fmild symptoms receive a community health worker (CHW) trained to elicit illness understanding in a culturally competent way. In Tier 2, for patients with poorer function and mild symptoms, a social worker (SW), trained in serious illness communication, joins the CHW to further elicit patients' goals and prognostic understanding while communicating symptom needs to their primary clinician. In Tier 3, as function decreases and symptoms increase, an advance practice nurse (APN) joins the CHW and SW to manage complex symptoms. Finally, in Tier 4, for those older adults with the poorest function and most complex symptoms, a physician joins the team to ensure that the most complex needs (e.g., end-of-life treatment preferences and multifaceted symptom control) are met. The CHW follows patients longitudinally across all tiers and re-allocates them to the appropriate tier based on their evolving needs.",[27,259,260,261],"Advanced Non-Colorectal Gastrointestinal Cancer","Advanced Lung Cancer","Advanced Triple Negative Breast Cancer",[216,263,30,264],"community-based","advanced cancer","2026-02-02",{"date":238,"type":37},{"date":268,"type":21},"2026-05-01",{"date":270,"type":21},"2032-01-31",{"name":272,"class":44},"Icahn School of Medicine at Mount Sinai",5,{"id":275,"slug":276,"hasResults":11,"nctId":277,"briefTitle":278,"officialTitle":278,"acronym":4,"eligibilityCriteria":279,"healthyVolunteers":11,"sex":16,"minAge":280,"maxAge":4,"enrollmentInfo":281,"targetDuration":4,"studyType":183,"phases":4,"briefSummary":282,"conditions":283,"keywords":285,"overallStatus":99,"whyStopped":4,"lastUpdateSubmitDate":289,"lastUpdatePostDateStruct":290,"startDateStruct":292,"completionDateStruct":294,"leadSponsor":296,"locationsCount":109},"100579383","multi-site-feasibility-testing-of-the-ventricular-assist-device-anticipatory-guidance-tool-100579383","NCT06823583","Multi-Site Feasibility Testing of the Ventricular Assist Device Anticipatory Guidance Tool","Inclusion Criteria:\n\n(For patient inclusion):\n\n* scheduled for a VAD implantation\n* English-speaking as the VAD AG Tool v5.0 has not yet been translated beyond English age ≥19 years at the time of implant as most states in North America have an age of majority for consent signing.\n\n(-VAD clinician for the clinician evaluation process)\n\nExclusion Criteria:\n\n* Not scheduled for VAD surgery\n* Non English speaking\n* \\\u003C19 yrs of age (Not a VAD Clinician for the clinician evaluation process)","19 Years",{"count":91,"type":21},"There are a variety of educational documents available to help in a participant's decision for VAD implant, however there is little information available to potential participants to help understand areas of satisfaction and concern following a VAD implant as various time points. The investigators want to provide better patient care through increased education and awareness beyond surgical outcomes and contribute to patient understanding of \"what to expect\" following a VAD implant.\n\nThe investigators have created an anticipatory guidance (AG) tool based upon previous responses recorded in a local program's database, from the Quality of Life with a Left Ventricular Assist Device (QoLVAD) questionnaire. This questionnaire has five different domains (physical, social, emotional, cognitive thinking and spiritual\u002Fwell-being). Investigators have previously analyzed responses to determine common areas of satisfaction and concern at 3-, 6-, 12- and 24-months post-VAD implant to better understand quality of life when living with a VAD. Investigators have had both VAD clinicians and VAD patients initially evaluate the tool to determine accuracy and effectiveness of the anticipatory guidance (AG) tool.",[129,27,284],"Anticipatory Guidance",[286,287,27,284,288],"expectations","VAD","quality of life","2025-09-15",{"date":291,"type":37},"2025-09-19",{"date":293,"type":37},"2025-08-17",{"date":295,"type":21},"2026-12",{"name":297,"class":44},"Bryan Heart",{"id":299,"slug":300,"hasResults":11,"nctId":301,"briefTitle":302,"officialTitle":303,"acronym":304,"eligibilityCriteria":305,"healthyVolunteers":11,"sex":16,"minAge":280,"maxAge":4,"enrollmentInfo":306,"targetDuration":4,"studyType":22,"phases":308,"briefSummary":310,"conditions":311,"keywords":316,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":330,"lastUpdatePostDateStruct":331,"startDateStruct":333,"completionDateStruct":335,"leadSponsor":337,"locationsCount":45},"100599172","phase-4-trial-of-low-intensity-anticoagulation-to-reduce-gi-or-other-bleeding-complications-with-equivalent-therapeutic-efficacy-in-heartmate-3-lvad-patients-100599172","NCT07081035","Trial of Low-intensity Anticoagulation to Reduce GI or Other Bleeding Complications With Equivalent Therapeutic Efficacy in HeartMate 3 LVAD Patients","A Prospective Study Evaluating the Safety and Efficacy of Lower-Intensity INR Target (1.5-2.0) Versus Standard INR Target (2.0-3.0) in Patients Implanted With a HeartMate 3 Left Ventricular Assist Device (LVAD)","TARGET","Inclusion Criteria:\n\n* Patients who meet all of the following criteria will be eligible for randomization:\n\nAdults aged ≥19 years who have successfully undergone implantation of a HeartMate 3 LVAD.\n\nPatients who are at least 30 days post-implantation of HeartMate 3 LVAD.\n\nPatients who have maintained stable anticoagulation therapy with standard INR (2.0-3.0) for at least 30 days post-LVAD implantation.\n\nPatients or their legal representatives who provide documented informed consent and agree to the study protocol and follow-up schedule.\n\nExclusion Criteria:\n\n* Patients who meet any of the following criteria will be excluded:\n\nPatients implanted with any mechanical assist device other than HeartMate 3 LVAD (e.g., other LVAD models, RVAD, BiVAD).\n\nPatients with a clinically significant stroke or transient ischemic attack (TIA) within the past 6 months.\n\nPatients with a history of hemorrhagic stroke.\n\nPatients who experienced major bleeding events within the past 6 months (based on INTERMACS major bleeding criteria).\n\nPatients with uncontrolled severe hypertension (systolic ≥180 mmHg or diastolic ≥110 mmHg).\n\nPatients requiring active treatment or surgical intervention for acute LVAD-related thrombosis or hemodynamic instability, or patients who underwent LVAD-related reoperation within the past 30 days.\n\nPatients with severe renal dysfunction (estimated Glomerular Filtration Rate \\\u003C15 mL\u002Fmin) or patients undergoing dialysis.\n\nPatients with severe liver dysfunction causing coagulation abnormalities or those classified as Child-Pugh class B or C.\n\nPatients with active bleeding or ongoing hemorrhagic conditions.\n\nPatients with a high bleeding risk due to:\n\nGastrointestinal bleeding or ulcers within the past 6 months.\n\nSurgery involving the brain, spine, or eyes within the past 6 months.\n\nMajor central nervous system, ophthalmologic, or major open surgical procedures within the past 6 months.\n\nPresence or suspicion of esophageal varices.\n\nArteriovenous malformation or vascular aneurysm.\n\nPatients who have received thrombolytic therapy for bleeding or thromboembolism within the past 30 days.\n\nPatients receiving long-term concurrent treatment with other anticoagulants (low molecular weight heparin, NOAC, Fondaparinux, etc.). However, temporary administration for warfarin bridging or heparin use for central venous or arterial catheter maintenance is permitted.\n\nPatients with persistent anemia (hemoglobin \\\u003C8 g\u002FdL) or thrombocytopenia (platelet count \\\u003C50,000\u002FµL) within the past 6 months.\n\nPatients currently experiencing infective endocarditis.\n\nPatients with a history of severe allergy or hypersensitivity to warfarin or other anticoagulants used in this study.\n\nPregnant or lactating women, or women planning pregnancy during the study period.\n\nPatients with severe terminal illness with a life expectancy of less than 12 months.\n\nPatients with alcohol dependence or severe psychiatric conditions hindering study participation.\n\nPatients unwilling or unable to adhere to the procedures or evaluations required by the study protocol.\n\nPatients currently participating in another randomized drug or medical device clinical trial who have not yet completed the primary endpoint assessment.",{"count":307,"type":21},94,[309],"PHASE4","The TARGET trial is a prospective, single-center, randomized, open-label, active-controlled inequality clinical trial designed to evaluate the safety and efficacy of low-intensity anticoagulation therapy (target INR 1.5-2.0) compared to standard anticoagulation therapy (target INR 2.0-3.0) in patients receiving a HeartMate 3 Left Ventricular Assist Device (LVAD).\n\nDespite the demonstrated effectiveness of HeartMate 3 LVAD in reducing thromboembolic complications, standard anticoagulation treatment guidelines recommend maintaining an INR between 2.0 and 3.0, which can lead to a substantial risk of bleeding, especially gastrointestinal (GI) bleeding. Preliminary studies, such as MAGENTUM 1, have indicated potential safety and reduced bleeding events at lower INR targets (1.5-1.9). However, robust evidence through randomized controlled trials is still required.\n\nThe primary objective of the TARGET trial is to determine if low-intensity anticoagulation therapy significantly reduces the incidence of major bleeding and thrombotic events compared to standard therapy within 6 months post-randomization. Secondary objectives include evaluating the safety and hematological complications associated with low-intensity anticoagulation.\n\nThe study will enroll adult patients aged ≥19 years who have been stably maintained on standard INR therapy (2.0-3.0) for at least 30 days post-HeartMate 3 LVAD implantation. Participants will be randomized in a 1:1 ratio into two groups: the low-intensity INR group (target INR 1.5-2.0) and the standard INR group (target INR 2.0-3.0). Randomization will be stratified based on the presence of atrial fibrillation.\n\nThe primary endpoint is a composite of hemocompatibility-related events, including major bleeding, stroke, and pump thrombosis, occurring within 6 months after randomization, as defined by INTERMACS criteria. Secondary endpoints encompass clinical outcomes such as all-cause mortality, cardiac death, LVAD-related thromboembolic events, stroke, systemic embolism, myocardial infarction, major bleeding incidents, and the rate and number of LVAD-related hospital readmissions and reoperations. Additionally, INR management outcomes, including time in therapeutic range (TTR) and frequency of warfarin dose adjustments, will be assessed.\n\nThe trial duration is approximately 36 months, including a 24-month enrollment period, a 6-month follow-up period for each participant, and time allocated for data analysis and reporting. Safety will be rigorously monitored by a Data Safety Monitoring Board (DSMB) and Clinical Events Committee (CEC), ensuring participant safety and data integrity throughout the study.\n\nThis trial aims to provide critical insights that could optimize anticoagulation strategies in LVAD patients, potentially improving patient safety by reducing bleeding risks without compromising thrombotic event protection.",[27,312,313,314,315],"Left Ventricular Assist Devices","Anticoagulation Treatment","Bleeding Complications","Thrombotic Complications",[317,124,27,318,319,320,321,322,323,324,325,326,327,328,329],"HeartMate 3 LVAD","Anticoagulation","Warfarin","International Normalized Ratio (INR)","Low-intensity Anticoagulation","Major Bleeding","Gastrointestinal Bleeding","Pump Thrombosis","Stroke","Thromboembolism","Hemocompatibility","Randomized Controlled Trial","Safety and Efficacy","2025-07-15",{"date":332,"type":37},"2025-07-23",{"date":334,"type":21},"2025-10",{"date":336,"type":21},"2029-01",{"name":338,"class":44},"Asan Medical Center",{"id":340,"slug":341,"hasResults":11,"nctId":342,"briefTitle":343,"officialTitle":344,"acronym":345,"eligibilityCriteria":346,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":347,"targetDuration":4,"studyType":183,"phases":4,"briefSummary":349,"conditions":350,"keywords":351,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":356,"lastUpdatePostDateStruct":357,"startDateStruct":359,"completionDateStruct":361,"leadSponsor":363,"locationsCount":45},"100596890","wearables-and-artificial-intelligence-in-advanced-heart-failure-care-100596890","NCT07051356","Wearables and Artificial Intelligence in Advanced Heart Failure Care","Advancing Proactive Care in Advanced Heart Failure: Integrating AI and Continuous Remote Monitoring for Early Detection of Heart Failure Deterioration","WAI-HF","Inclusion Criteria:\n\n* \\>18 years.\n* Diagnosis of advanced heart failure, including at least one of the following major criteria.\n\n  * LVAD implanted\n  * Included on the waiting list for Heart transplant\n  * Meeting the European Society of CArdiology criteria for advanced HF:\n* Severe and persistent symptoms of heart failure \\[NYHA class III or IV\\].\n* Severe cardiac dysfunction: according to ESC guidelines definition\n* ≥ 1 unplanned visit or hospitalization in the last 12 months requiring IV treatment.\n* Have access to a mobile phone or tablet with an operating system iSO 15 or Android 9 (or posterior versions of these systems).\n\nExclusion Criteria:\n\n* Impossibility to provide inform consent.\n* Impossibility to self-report data due to physical or mental disability.",{"count":348,"type":21},200,"The goal of this observational study is to evaluate whether AI-based analyses of wearable sensor data can identify early signs of deterioration leading to hospitalization in patients with advanced heart failure.\n\nThe main questions it aims to answer are:\n\n* Can AI-driven analysis of wearable data detect physiological or behavioral changes associated with impending hospital admissions?\n* Does wearable-based remote monitoring influence daily exercise duration in patients with advanced heart failure.\n* Is wearable-based remote monitoring usable and acceptable for patients with advanced heart failure in a real-world setting?\n\nParticipants will wear a wrist-worn (Fitbit) device continuously for one year and will use an eHealth app to answer question about their symptoms. Participant's physical activity, heart rate, heart rate variability, respiratory rate, sleep quality, and symptomatic status will be monitored remotely.",[27],[65,352,353,354,355],"Wearable device","Artificial intelligence","Remote monitoring","Left ventricular assist device","2025-06-25",{"date":358,"type":37},"2025-07-04",{"date":360,"type":21},"2025-07",{"date":362,"type":21},"2027-08",{"name":364,"class":44},"UMC Utrecht",{"id":366,"slug":367,"hasResults":11,"nctId":368,"briefTitle":369,"officialTitle":369,"acronym":4,"eligibilityCriteria":370,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":89,"enrollmentInfo":371,"targetDuration":372,"studyType":183,"phases":4,"briefSummary":373,"conditions":374,"keywords":4,"overallStatus":99,"whyStopped":4,"lastUpdateSubmitDate":375,"lastUpdatePostDateStruct":376,"startDateStruct":378,"completionDateStruct":380,"leadSponsor":382,"locationsCount":45},"100460099","conservative-management-of-left-ventricular-assist-device-candidates-100460099","NCT05271214","Conservative Management of Left Ventricular Assist Device Candidates","Inclusion Criteria:\n\n\\- left ventricular ejection fraction \\\u003C35%. New York Heart Association Class III or IV. Brain natriuretic peptide levels \\> 450pg\u002Fml. Heart failure hospitalization in the past 6 months. Maximal oxygen consumption \\\u003C 12 ml\u002Fkg\u002Fmin. Intolerant to conventional heart failure therapy.\n\nExclusion Criteria:\n\n\\- Special populations - pregnant, unable to give informed consent. Advanced liver disease (Child Pugh class B or C). Advanced kidney disease (eGFR\\\u003C30ml\u002Fmin). Severe pulmonary disease. Severe peripheral vascular disease. Active malignancy.",{"count":20,"type":21},"5 Years","Left ventricular assist device (LVAD) candidates will be comprehensively evaluated at our center, including clinical evaluation, echocardiography, right heart catheterization, cardiopulmonary exercise test and laboratory exams. following this evaluation, patients will be treated with inotropes, diuretics, uptitrated neurohormonal therapy. vitamin and iron deficiencies will be corrected and the patients will be referred for coronary interventions and cardiac resynchronization therapy appropriately. The need for LVAD implantation will be reevaluated according to the patient's clinical condition, echocardiography and laboratory findings.",[27],"2022-02-26",{"date":377,"type":37},"2022-03-08",{"date":379,"type":37},"2018-01-01",{"date":381,"type":21},"2028-01",{"name":383,"class":384},"Tel-Aviv Sourasky Medical Center","OTHER_GOV"]