[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"left-ventricular-assist-devices\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:left-ventricular-assist-devices":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,42],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100597063","interventional-left-ventricular-assist-system-for-pci-in-chip-patients-100597063",false,"NCT07053618","Interventional Left Ventricular Assist System for PCI in CHIP Patients","Interventional Left Ventricular Assist System for PCI in CHIP Patients: a Prospective, Multicenter, Noninferiority Randomized Controlled Trial","Inclusion Criteria:\n\n1\\. Aged 18-90 2. The investigator assesses that the subject requires coronary revascularization, but CABG (Coronary Artery Bypass Grafting) is considered high-risk or the subject refuses CABG. The investigator believes the subject may benefit from PCI (Percutaneous Coronary Intervention).\n\n3\\. Left ventricular ejection fraction (LVEF) ≤ 35%. 4. Coronary angiography (CAG) or coronary computed tomography angiography (CTA) shows any of the following conditions:\n\n1. Unprotected left main (LM) coronary artery disease (coronary stenosis ≥ 50%).\n2. A last remaining patent coronary artery (the anterior descending artery (LAD) and\u002For its branches, the circumflex artery (LCX) and\u002For its branches, and the right coronary artery (RCA) and\u002For its branches).\n3. Saphenous vein graft (SVG) vascular lesions.\n4. Severely calcification, tortuosity.\n5. Multivessel disease (two or more) combined with chronic total occlusion (CTO).\n6. Three-vessel disease. Three-vessel disease is defined as significant stenosis (≥ 70%) in at least one segment of all three major epicardial coronary artery territories: the left anterior descending artery (LAD) and\u002For its branches, the left circumflex artery (LCX) and\u002For its branches, and the right coronary artery (RCA) and\u002For its branches. In a left-dominant coronary system, lesions in the proximal segments of the LAD and LCX are also considered three-vessel disease.\n\n5\\. Patients who are able to give informed consent and complete the follow-up.\n\nExclusion Criteria:\n\n1. Cardiogenic shock (CS) within 7 days (Cardiogenic shock: Sustained SBP \\\u003C90 mmHg for ≥30 min or requiring supportive measures to maintain SBP \\>90 mmHg and end-organ hypoperfusion (urine output \\\u003C30 ml\u002Fh or cool extremities).\n2. STEMI or CK-MB did not return to the normal range within 24 hours.\n3. Cardiac arrest with cardiopulmonary resuscitation within 24 hours.\n4. Left ventricular mural thrombus.\n5. After aortic valve replacement surgery (mechanical, bioprosthetic).\n6. Having used or using ECMO or pVAD (percutaneous ventricular assist device) within 7 days.\n7. Moderate to severe aortic stenosis, moderate to severe aortic valve insufficiency.\n8. Atrial septal or ventricular septal defects (including post-infarction VSD), or post-myocardial infarction Free-Wall Rupture, or papillary muscle rupture.\n9. Severe right heart failure or severe tricuspid valve insufficiency.\n10. Disease or abnormality of the aorta that interferes with the procedure, including Marfan syndrome, coarctation of aortic, aortic aneurysm, severe tortuosity or calcification of the aorta.\n11. Severe peripheral arterial stenosis or occlusive lesions.\n12. Uncorrectable moderate or severe anemia prior to the procedure (hemoglobin \\\u003C90 g\u002FL). Abnormal coagulation function (routine blood test indicates platelet count less than 75×109\u002FL, INR ≥2.0, or fibrinogen ≤1.5 g\u002FL).\n13. Known contraindications to heparin, contrast agents, or study-required medications (e.g., aspirin, clopidogrel); history of Heparin-induced thrombocytopenia.\n14. Active hemorrhage within 1 month.\n15. History of stroke or TIA or permanent neurologic deficits within one month prior to the procedure.\n16. Renal dysfunction: subject on dialysis or serum creatinine ≥4 mg\u002FdL (353.6 µmol\u002FL) within 7 days.\n17. Liver dysfunction: liver AST, ALT and bilirubin \\>3 times the upper limit of normal within 7 days.\n18. Presence or suspected presence of infective endocarditis or systemic infection.\n19. Women who are pregnant, breastfeeding, or planning pregnancy during the trial.\n20. Participation in another drug or medical device clinical trial.\n21. Other conditions deemed by the investigator as unsuitable for participation in this trial.\n\n    \\-","ALL","18 Years","90 Years",{"count":20,"type":21},286,"ESTIMATED","INTERVENTIONAL",[24],"NA","Mechanical circulatory support (MCS) is a life-sustaining therapy first introduced in the 1950s. After six decades of development, it now serves as a critical bridge therapy for patients with acute cardiac events and end-stage heart failure. Percutaneous mechanical circulatory support (pMCS), a key MCS modality, has advanced rapidly in recent years.\n\nIn China, pMCS adoption has accelerated significantly, evidenced by year-over-year growth in both specialized centers and clinical cases, alongside continuous technological refinement.\n\nCommon pMCS devices include: Intra-Aortic Balloon Pump (IABP), Axial flow pump systems (e.g., Impella®), Extracorporeal Membrane Oxygenation (ECMO). However, no randomized study has compared Impella with VA-ECMO in CHIP patients.\n\nThe aim of the study is to evaluate the effectiveness and safety of interventional left ventricular assist system (VADLINK) compared to the VA-ECMO in providing circulatory support for complicated and high-risk patient with indications for PCI.",[27,28],"High-Risk Percutaneous Coronary Intervention (High-risk PCI)","Left Ventricular Assist Devices","RECRUITING","2025-08-25",{"date":32,"type":33},"2025-08-26","ACTUAL",{"date":35,"type":33},"2025-08-06",{"date":37,"type":21},"2027-08-01",{"name":39,"class":40},"Suzhou Hengruihongyuan Medical Technology Co. LTD","INDUSTRY",15,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":16,"minAge":50,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":22,"phases":53,"briefSummary":55,"conditions":56,"keywords":61,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":87},"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.","19 Years",{"count":52,"type":21},94,[54],"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.",[57,28,58,59,60],"Advanced Heart Failure","Anticoagulation Treatment","Bleeding Complications","Thrombotic Complications",[62,63,57,64,65,66,67,68,69,70,71,72,73,74,75],"HeartMate 3 LVAD","Left Ventricular Assist Device","Anticoagulation","Warfarin","International Normalized Ratio (INR)","Low-intensity Anticoagulation","Major Bleeding","Gastrointestinal Bleeding","Pump Thrombosis","Stroke","Thromboembolism","Hemocompatibility","Randomized Controlled Trial","Safety and Efficacy","NOT_YET_RECRUITING","2025-07-15",{"date":79,"type":33},"2025-07-23",{"date":81,"type":21},"2025-10",{"date":83,"type":21},"2029-01",{"name":85,"class":86},"Asan Medical Center","OTHER",1]