[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"lvad\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:lvad":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,55,95,119,147],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":39,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":44,"lastUpdatePostDateStruct":45,"startDateStruct":48,"completionDateStruct":50,"leadSponsor":52,"locationsCount":4},"100642101","phase-4-study-of-aspirin-removal-in-patients-supported-by-the-fully-magnetically-levitated-ch-vad-pump-100642101",false,"NCT07644247","STudy of Aspirin Removal in Patients Supported by the Fully Magnetically Levitated CH-VAD Pump","A Multicenter, Prospective, Randomized, Double-Blind, Placebo-Controlled STudy of Aspirin Removal in Patients Supported by the Fully Magnetically Levitated CH-VAD Pump (STAR Trial)","STAR","Inclusion Criteria:\n\n\\-\n\nStudy participants must meet all the following criteria:\n\n1. Age ≥18 years old;\n2. Implanted with the CH-VAD pump for advanced heart failure, and the CH-VAD pump is the first implanted left ventricular assist device;\n3. Able to understand the study purpose, voluntarily participate and sign the informed consent form, and willing to comply with the study procedures and follow-up requirements.\n\nExclusion Criteria:\n\n\\-\n\nStudy participants meet any of the following criteria will be excluded:\n\n1. Requirement for additional temporary or permanent mechanical circulatory support after LVAD implantation;\n2. Requirement for physician-mandated antiplatelet therapy after implantation due to medical history, surgical history, concomitant surgical procedures, or other conditions, including mandated presence or absence of antiplatelet agent;\n3. Occurrence of primary endpoint events prior to randomization (within 2-7 days after implantation);\n4. Inability to take oral medications post-implant through 7 days;\n5. Known allergy to aspirin;\n6. Participation in another clinical investigation that may affect study outcome;\n7. Presence of other comorbid conditions, social or psychological conditions, or other conditions, in the investigator's opinion, that may affect participation in the study or compliance with follow-up requirements.","ALL","18 Years",{"count":20,"type":21},370,"ESTIMATED","INTERVENTIONAL",[24],"PHASE4","This multi-center, prospective, randomized, double-blinded, placebo-controlled study aims to investigate whether withdrawal of aspirin from the antithrombotic regimen in patients supported with the CH-VAD pump is non-inferior to the standard antithrombotic regimen of vitamin K antagonist combined with aspirin in terms of safety and efficacy.",[27,28,29,30,31,32,33,34,35,36,37,38],"LVAD (Left Ventricular Assist Device) Thrombosis","LVAD","LVAD (Left Ventricular Assist Device)","LVAD-related GI Bleed","Bleeding","Thrombosis","Stroke","Hemocompatibility-related Adverse Event","Ventricular Assist Device","Aspirin","Antiplatelet Therapy","Antithrombotic Therapy",[40,28,33,31,32,41,36,42],"Left ventricular assist device","Hemocompatibility","Antiplatelet","NOT_YET_RECRUITING","2026-06-08",{"date":46,"type":47},"2026-06-12","ACTUAL",{"date":49,"type":21},"2026-06-25",{"date":51,"type":21},"2029-12-31",{"name":53,"class":54},"China National Center for Cardiovascular Diseases","OTHER_GOV",{"id":56,"slug":57,"hasResults":11,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":61,"eligibilityCriteria":62,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":63,"targetDuration":4,"studyType":22,"phases":65,"briefSummary":67,"conditions":68,"keywords":81,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":94},"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":64,"type":21},78,[66],"NA","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.",[69,70,71,28,72,73,74,35,75,76,77,78,79,80],"Heart Failure","Advanced Heart Failure","Left Ventricular Assist Device","Cardiac Rehabilitation","Telemedicine","Remote Exercise","Exercise Training","Conditioning Therapy","Cardiopulmonary Exercise Test","Six Minute Walk Test","Quality of Life","Telerehabilitation",[71,70,69,72,82,73,83,79,77,80],"Remote rehabilitation","6 minute walking test","2026-05-20",{"date":86,"type":47},"2026-05-28",{"date":88,"type":21},"2026-05",{"date":90,"type":21},"2030-12",{"name":92,"class":93},"Puerta de Hierro University Hospital","OTHER",10,{"id":96,"slug":97,"hasResults":11,"nctId":98,"briefTitle":99,"officialTitle":99,"acronym":100,"eligibilityCriteria":101,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":102,"targetDuration":4,"studyType":22,"phases":104,"briefSummary":105,"conditions":106,"keywords":4,"overallStatus":108,"whyStopped":4,"lastUpdateSubmitDate":109,"lastUpdatePostDateStruct":110,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":116,"locationsCount":118},"100595603","effects-of-negative-pressure-ventilation-onto-hemodynamics-and-right-ventricular-funktion-in-patients-after-implantation-of-a-left-ventricular-assist-device-100595603","NCT07034599","Effects of Negative Pressure Ventilation Onto Hemodynamics and Right Ventricular Funktion in Patients After Implantation of a Left Ventricular Assist Device.","NPV LVAD","Inclusion Criteria:\n\n* All patients after implantation of a durable left ventricular assist device\n\nExclusion Criteria:\n\n* Complication during surgery like bleeding, emergency, inability to fit the cuirass, unavailability of an investigator, unstable condition regarding circulation or ventilation",{"count":103,"type":21},30,[66],"All patients undergoing an implantation of a durable left ventricular assist device and monitored by pulmonary artery catheter showing no adverse events after surgery are included in the study and ventilated for 15 minutes using extra thoracic negative pressure ventilation and usual intrathoracic positive pressure ventilation. Hemodynamics changes between both ventilation modes, especially focussing on right ventricular function and measured by a pulmonary artery catheter, are compared.",[107,69,28],"Critical Illness","RECRUITING","2026-02-13",{"date":111,"type":47},"2026-02-18",{"date":113,"type":47},"2025-10-01",{"date":115,"type":21},"2026-12-01",{"name":117,"class":93},"Karlsburg Hospital",1,{"id":120,"slug":121,"hasResults":11,"nctId":122,"briefTitle":123,"officialTitle":123,"acronym":4,"eligibilityCriteria":124,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":125,"enrollmentInfo":126,"targetDuration":4,"studyType":128,"phases":4,"briefSummary":129,"conditions":130,"keywords":4,"overallStatus":108,"whyStopped":4,"lastUpdateSubmitDate":137,"lastUpdatePostDateStruct":138,"startDateStruct":140,"completionDateStruct":142,"leadSponsor":144,"locationsCount":146},"100519102","humanmachine-interface-what-the-heartmate-3--device-tells-us-about-the-future-100519102","NCT06039176","Human\u002FMachine Interface: What the HeartMate 3 ® Device Tells Us About the Future","Inclusion Criteria:\n\n* 18 years of age or older\n* Scheduled Heartmate 3 ® dLVAD implantation\n\nExclusion Criteria:\n\n* \\\u003C18 years of age\n* Scheduled for dLVAD that is NOT a Heartmate 3 (R) device","100 Years",{"count":127,"type":21},150,"OBSERVATIONAL","Durable left ventricular assist devices (dLVAD) have been increasingly utilized since the mid to late 1990s, with an uptick of utility starting in 2010 following expanded indications for therapy to not only include a bridge to transplantation strategy, but also for those individuals who suffer from advanced heart failure (HF) and do not qualify for cardiac transplantation. Despite the decreasing size of the newest generation devices leading to a lessened occurrence of adverse events, bleeding and infection still remain a concern for clinicians, as well as a general lack of predictability towards adverse events in individuals with a dLVAD in place. There is a lack of description in the literature currently, regarding the interface between what the pump data provides and what is seen in clinical practice. There also is little known about the effects of what is provided in the pump data, in correlation to quality-of-life following dLVAD implantation.\n\nTherefore, the purpose of this study is to prospectively analyze normal and abnormal pump data through pump operations such as suction events, low flow alarms as well as other adventitious alarms, PI events and power cable disconnects greater than 20 seconds, from the HeartMate 3 ® dLVAD in order to clinically correlate this data to quality of life, frailty and other various medical conditions and adverse events as defined by the Interagency Registry for Mechanically Assisted Circulatory Support (Intermacs). This will be achieved through two aims: 1) Evaluate the effectiveness of dLVAD pump operations data on clinical practice application (quality of life, frailty and various medical conditions, and adverse events such as GIB, RHF, infection, hypertension, arrhythmias and stroke); and 2) Evaluate correlations and relationships of longitudinal normal and abnormal dLVAD pump operations data, to demographic and clinical variables. This study is the first study to evaluate HeartMate 3 ® dLVAD pump operations data over time for effectiveness in the clinical practice.",[28,131,132,133,134,135,136,33],"Frailty","GI Bleed","Right Heart Failure","Infections","Hypertension","Arrhythmias","2025-12-08",{"date":139,"type":47},"2025-12-16",{"date":141,"type":47},"2023-10-27",{"date":143,"type":21},"2026-12-30",{"name":145,"class":93},"International Consortium of Circulatory Assist Clinicians",7,{"id":148,"slug":149,"hasResults":11,"nctId":150,"briefTitle":151,"officialTitle":152,"acronym":153,"eligibilityCriteria":154,"healthyVolunteers":11,"sex":17,"minAge":155,"maxAge":156,"enrollmentInfo":157,"targetDuration":4,"studyType":22,"phases":159,"briefSummary":160,"conditions":161,"keywords":164,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":167,"lastUpdatePostDateStruct":168,"startDateStruct":170,"completionDateStruct":172,"leadSponsor":174,"locationsCount":4},"100542836","pumps-for-kids-infants-and-neonates-pumpkin-the-jarvik-2015-pivotal-trial-100542836","NCT06348043","Pumps for Kids, Infants and Neonates (PumpKIN): The Jarvik 2015 Pivotal Trial","Circulatory Support in Pediatric Heart Failure Patients Using the Jarvik 2015 LVAD: A Pivotal","PumpKIN","Inclusion Criteria:\n\nChildren with severe (Ross or New York Heart Association) class IV HF despite optimal medical therapy (Interagency Registry for Mechanically Assisted Circulatory Support \\[INTERMACS\\] profile 1 or 2 for pediatrics) who require mechanical circulatory support as a bridge to transplant and meet all the criteria below:\n\n1. Males and females with body weight between 8 kg, and 30 kg\n2. Body surface area (BSA) between 0.4 m2 and 1.0 m2\n3. Two-ventricle circulation, including cardiomyopathy, repaired structural heart disease (e.g., anomalous left coronary artery from the pulmonary artery \\[ALCAPA\\], aortic stenosis) or acquired heart disease (e.g., , Kawasaki disease) 4. INTERMACS Profile 1 or 2 as evidenced by: a. Inability to wean from extra-corporeal membrane oxygenation (ECMO) or other temporary circulatory support (TCS), OR b.Inability to wean from mechanical ventilator support, OR c. Inotrope-dependent,decompensatedHFANDmeetoneormoreofthe following severity criteria within 48 hours prior to implant (unless otherwise noted), attributed to decompensated HF despite optimal medical therapy: i. Urine output \\\u003C0.5 cc\u002Fkg\u002Fhour for 12hr ii. Creatinine level \\>2 times the upper limit of normal (ULN) for age iii. Alanine aminotransferase (ALT) or total bilirubin level \\>3 times the ULN for age (either qualifies the patient) iv. Mixed venous oxygen saturation (SvO2) \\\u003C55% (or arteriovenous oxygen difference \\>45%) v. Acidosis: Base excess \\>-5 vi. Inability to tolerate appropriate enteral calories vii. Inability to ambulate or participate in age-appropriate activities of daily living (ADLs) and\u002For cardiac rehabilitation\u002Fphysical therapy\n\n5\\. LVAD support is intended for bridge-to transplant. Subject is listed for transplant or eligible (i.e., no medical or surgical contraindications) to be listed for cardiac transplant, United Network for Organ Sharing (UNOS) status 1A, or equivalent 6. Implant performed at a US or European site participating in the Jarvik 2015 IDE Pivotal Trial.\n\n7\\. Written consent of parent(s) or legally authorized representative (LAR) where appropriate.\n\nExclusion Criteria:1. Severe right ventricular (RV) dysfunction or significant arrhythmia where treatment with a durable RV assist device (RVAD) (i.e., biventricular assist device) is definite or highly likely. 2. Complex cardiac anatomy including but not limited to:\n\n1. Single ventricle anatomy\n2. Presence of a mechanical heart valve\n3. Unrepairable severe aortic insufficiency 3. Stable inotrope dependence (INTERMACS profile 3) 4. Severe or irreversible renal dysfunction, liver dysfunction or pulmonary dysfunction. 5. Known contraindication to systemic anticoagulation (e.g., coagulopathy) 6. CPR with duration \\>30 consecutive minutes within 48 hours prior to device implant or CPR with uncertain neurological status 7. ECMO use for \\>10 consecutive days 8. Known cerebrovascular event within the past 30 days or uncertain neurological status 9. Unmanageable bleeding per judgment of the investigator 10. Ventricular dysfunction that is likely to recover (e.g., acute myocarditis, metabolic myopathy where LV dysfunction is present solely with intermittent acidosis\u002Fcrises).\n\n   11\\. A non-dilated LV as determined by a left ventricular end-diastolic dimension or left ventricular end-diastolic volume z score of \\\u003C+2.5 12. Systolic dysfunction that is not severe (LV ejection fraction of \\>35%) (e.g., heart failure with preserved ejection fraction, aka primary diastolic dysfunction). 12. Unresolved malignancy 13. Active, systemic infection unresponsive to antimicrobials therapy 14. Currently participating in an interventional trial whose protocol prevents effective application of the Jarvik 2015 device, potentially has an independent effect on trial endpoints, or otherwise interferes with execution of the PumpKIN protocol","6 Months","16 Years",{"count":158,"type":21},22,[66],"This is a 22-subject prospective, multicenter, single-arm clinical trial to evaluate the safety and effectiveness of the Jarvik 2015 left ventricular assist device (LVAD) as a bridge to heart transplant in children weighing 8 to 30 kilograms. Data generated from the study will be used to support FDA review and potential approval of the device under the Humanitarian Device Exemption (HDE) regulation, the FDA approval pathway for devices intended to treat rare and orphan diseases.",[162,163,28],"Heart Failure With Reduced Ejection Fraction","Pediatric HD, Stage IV",[28,165,166],"Pediatric heart failure","advanced cardiac therapies","2024-03-29",{"date":169,"type":47},"2024-04-04",{"date":171,"type":21},"2024-08",{"date":173,"type":21},"2029-12",{"name":175,"class":93},"Stanford University"]