[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"heart-valve-diseases\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:heart-valve-diseases":26},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,30,0,25,[9,40,73,103,130,152,171,193,225,253,274,300,328,353,379,407,436,472,493,519,538,563,589,623,643],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":39},"100396438","the-study-of-biological-prosthetic-heart-valves-with-the-easy-change-system-100396438",false,"NCT04442100","The Study of Biological Prosthetic Heart Valves With the \"Easy Change\" System","Inclusion Criteria:\n\n1. aortic valve disease requiring surgical disease patients without symptoms with severe aortic stenosis - indexed area of the opening less than 0.5 cm2 \u002F m2, average gradient more than 40 mm RT. Art;\n\n   o patients who require coronary artery bypass grafting with moderate aortic stenosis - indexed area of the hole 0.5 - 1 cm2 \u002F m2, the average gradient is more than 20 mm RT. Art., Regardless of symptoms;patients with symptoms of aortic stenosis, regardless of the severity of stenosis)\n2. mitral valve disease requiring surgical disease\n\nExclusion Criteria:\n\n1. the need for prosthetics of two or more valves\n2. patients with a decrease in LVEF of less than 45%;\n3. the presence of a competing disease or concomitant pathology that significantly affects the prognosis of quality of life or the likelihood of death\n4. high pulmonary hypertension (SDJ above 60 mm Hg. Art.);\n5. the diameter of the ascending aorta is more than 45 mm;\n6. unwillingness of the patient to participate in the study.","ALL","60 Years",{"count":19,"type":20},500,"ESTIMATED","INTERVENTIONAL",[23],"NA","The study of new biological heart valves with the \"easy change\" system, including an assessment of the basic hemodynamic characteristics of the prosthesis, complications associated with valve implantation, and general mortality",[26],"Heart Valve Diseases","RECRUITING","2026-06-25",{"date":30,"type":31},"2026-06-26","ACTUAL",{"date":33,"type":31},"2016-11-29",{"date":35,"type":20},"2026-12-31",{"name":37,"class":38},"Tomsk National Research Medical Center of the Russian Academy of Sciences","OTHER",1,{"id":41,"slug":42,"hasResults":12,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":46,"eligibilityCriteria":47,"healthyVolunteers":12,"sex":16,"minAge":48,"maxAge":4,"enrollmentInfo":49,"targetDuration":4,"studyType":21,"phases":51,"briefSummary":52,"conditions":53,"keywords":57,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":50},"100509475","efs-of-the-duo-system-for-tricuspid-regurgitation-100509475","NCT05913908","EFS of the DUO System for Tricuspid Regurgitation","Early Feasibility Study of the DUO Transcatheter Tricuspid Coaptation Valve System in Patients With Tricuspid Regurgitation","TANDEM II","Inclusion Criteria:\n\n1. Presence of severe or greater tricuspid regurgitation as determined by the Echo Core Lab.\n2. Patient is symptomatic despite medical therapy.\n3. The local Site Heart Team determines the Patient is appropriate for transcatheter valve intervention.\n4. The Patient's anatomy is suitable in the judgment of the Patient Selection Committee.\n5. Age ≥18 years\n6. The Patient has been informed of the nature of the study and agrees to its provisions and has provided written Informed Consent.\n\nExclusion Criteria:\n\n1. Patient is currently participating in another clinical investigation that could affect the outcome of this trial.\n2. Any previous tricuspid valve intervention that would interfere with the placement of the investigational device.\n3. Moderate or greater tricuspid valve stenosis.\n4. Severe aortic, mitral and\u002For pulmonic valve stenosis and\u002For regurgitation\n5. Pacemaker or implantable cardioverter-defibrillator (ICD) leads that would prevent appropriate placement of the investigational device.\n6. Need for concomitant surgical or interventional procedure, known at the time of screening (e.g., CABG, Atrial Septal Defect (ASD) repair).\n7. Ejection Fraction (EF) \\\u003C25%\n8. Echocardiographic evidence of unstable intracardiac mass, thrombus or vegetation\n9. Patient has Systolic Pulmonary Pressure (sPAP) \\>60 mm Hg\n10. Severe hemodynamic instability: cardiogenic shock or the need for inotropic support or Intra-Aortic Balloon Pump (IABP) or other percutaneous ventricular assist devices\n11. Severe respiratory instability with continuous use of home oxygen\n12. Severe right ventricular dysfunction\n13. Untreated clinically significant coronary or carotid artery disease requiring revascularization surgical or interventional PCI.\n14. Stroke or transient ischemic event within 90 days prior to the index procedure\n15. Acute myocardial infarction within 30 days before the index procedure\n16. Renal insufficiency (eGFR \\\u003C25 ml\u002Fmin) or currently on chronic dialysis\n17. Active endocarditis within 6 months of the index procedure\n18. Pulmonary embolism or deep vein thrombosis within the last 6 months\n19. Any surgical, interventional, or transcatheter procedure within 30 days prior to the index procedure\n20. Hypertrophic cardiomyopathy, restrictive cardiomyopathy or constrictive pericarditis\n21. Life expectancy \\\u003C1 year\n22. Active infections requiring current antibiotic therapy\n23. Known severe liver disease\n24. Is on the waiting list for a transplant or has had a prior heart or lung transplant\n25. Known active peptic ulcer or active GI bleed\n26. Unable to take anticoagulant therapy\n27. Any known major coagulation abnormalities, thrombocytopenia, platelets \\\u003C 50,000\u002Fml or severe anemia Hb \\\u003C8 g\u002Fdl\n28. Known patient is actively abusing drugs\n29. Any known sensitivities or allergies to contrast (that cannot be adequately premedicated) and\u002For the device materials, including nickel and titanium\n30. Patients who are pregnant or intend to become pregnant\n31. Any condition making it unlikely the Patient will be able to complete all protocol procedures (including compliance with optimal medical therapy and immobility that would prevent completion of 6MWT), follow-up visits, or impact the scientific soundness of the clinical investigation result","18 Years",{"count":50,"type":20},15,[23],"The study is an early feasibility study to measure individual patient clinical outcomes and effectiveness, evaluate the safety and function of the DUO Transcatheter Tricuspid Coaptation Valve System (DUO System).",[54,55,56,26],"Tricuspid Regurgitation","Tricuspid Valve Insufficiency","Tricuspid Valve Disease",[58,59,60,61,62],"Transcatheter","Coaptation Valve","TR","SVC","Tricuspid","2026-05-28",{"date":65,"type":31},"2026-06-01",{"date":67,"type":31},"2024-08-13",{"date":69,"type":20},"2029-10",{"name":71,"class":72},"CroiValve Limited","INDUSTRY",{"id":74,"slug":75,"hasResults":12,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":79,"eligibilityCriteria":80,"healthyVolunteers":12,"sex":16,"minAge":48,"maxAge":4,"enrollmentInfo":81,"targetDuration":83,"studyType":84,"phases":4,"briefSummary":85,"conditions":86,"keywords":91,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":39},"100638834","multimodal-magnetic-resonance-imaging-in-cardiovascular-disease-100638834","NCT07617844","Multimodal mAgnetic Resonance imaGIng in Cardiovascular Disease","Multimodal-MRI in Cardiovascular Diseases","MAGIC","Inclusion Criteria:\n\n* Aged 18 years and older, with no gender restrictions.\n\nClinically suspected or confirmed cardiovascular disease (including but not limited to ischemic heart disease, non-ischemic cardiomyopathy, myocarditis, valvular disease, etc.), requiring a cardiac magnetic resonance (CMR) examination to determine the etiology or evaluate myocardial tissue characteristics.\n\nNo contraindications to magnetic resonance examination, and able to cooperate with breath-holding instructions.\n\nVoluntarily participate in this study and sign a written informed consent form.\n\nExclusion Criteria:\n\n* Absolute contraindications: Implantation of non-MRI compatible metallic foreign bodies (e.g., old pacemakers, implantable cardioverter-defibrillators \\[ICD\\], aneurysm clips, etc.).\n\nRelative contraindications: Severe claustrophobia, unable to complete the examination despite communication.\n\nSevere renal insufficiency.\n\nSpecial populations: Pregnant or lactating women.\n\nPresence of severe arrhythmias (e.g., persistent atrial fibrillation) leading to severely impaired magnetic resonance signal acquisition, rendering the image quality inadequate for diagnosis.\n\nPoor expected compliance: Unable to complete follow-up, or deemed unsuitable for enrollment by the investigator for other reasons.",{"count":82,"type":20},2000,"3 Years","OBSERVATIONAL","This single-center, prospective, observational cohort study aims to evaluate the clinical application value of multi-modal cardiovascular magnetic resonance (CMR) imaging in patients with cardiovascular diseases (CVD).\n\nWhile traditional imaging methods have limitations in fully evaluating myocardial tissue characteristics, multi-modal CMR offers a comprehensive, non-invasive \"one-stop\" assessment. It can simultaneously evaluate heart structure, function, tissue features (such as fibrosis and edema), and hemodynamics.\n\nThe study plans to enroll patients with suspected or confirmed CVD. Participants will undergo a comprehensive multi-modal CMR scan (including Cine, T1\u002FT2 mapping, Late Gadolinium Enhancement, and 4D flow sequences) as part of their evaluation. By tracking clinical outcomes, the study seeks to establish a standardized imaging assessment system to improve the early detection, accurate diagnosis, risk stratification, and prognostic prediction for various types of cardiovascular diseases.",[87,88,89,90,26],"Cardiovascular Diseases","Ischemic Heart Disease (IHD)","Cardiomyopathy","Myocarditis",[92,93,94],"Cardiac Magnetic Resonance","Magnetic Resonance Imaging","Multimodal Imaging","2026-05-26",{"date":65,"type":31},{"date":98,"type":31},"2026-01-01",{"date":100,"type":20},"2028-12-31",{"name":102,"class":38},"Second Affiliated Hospital, School of Medicine, Zhejiang University",{"id":104,"slug":105,"hasResults":12,"nctId":106,"briefTitle":107,"officialTitle":108,"acronym":109,"eligibilityCriteria":110,"healthyVolunteers":12,"sex":16,"minAge":48,"maxAge":111,"enrollmentInfo":112,"targetDuration":4,"studyType":21,"phases":114,"briefSummary":115,"conditions":116,"keywords":4,"overallStatus":119,"whyStopped":4,"lastUpdateSubmitDate":120,"lastUpdatePostDateStruct":121,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":127,"locationsCount":129},"100551347","pivotal-trial-to-evaluate-the-safety-and-effectiveness-of-the-pf-tricvalve-transcatheter-bicaval-valve-system-100551347","NCT06458907","Pivotal Trial to Evaluate the Safety and Effectiveness of the P&F TricValve® Transcatheter Bicaval Valve System","A Prospective, Randomized Multicenter Clinical Trial of the TricValve® Transcatheter Bicaval Valve System in Subjects With Severe Tricuspid Regurgitation.","TRICAV-II","Eligibility Criteria for Randomized Cohort:\n\nInclusion Criteria:\n\n1. Age between 18 years and 85 years old, at the time of signing the informed consent.\n2. Severe tricuspid regurgitation (TR) and Caval Reflux (CR), as determined by the qualifying transthoracic echocardiogram (TTE) confirmed by an echocardiography Core Lab. TVARC criteria will be used for the definition of TR severity.\n3. NYHA Class II-III-IVa (not on inotropes, IABP or LVAD) or heart failure (HF) admission in the past 6 months.\n4. Adequately treated with optimal medical therapy (OMT) for heart failure per the local Heart Team at the time of TR assessment for eligibility (TTE). OMT includes stable oral diuretic medications.\n5. High risk for open surgery and is appropriate for transcatheter tricuspid therapies according to the local heart team.\n6. Patient is unsuitable for approved transcatheter therapies and is eligible for the TricValve procedure, based on review of screening\u002Fbaseline data and imaging core lab measurements by Central Screening Committee.\n7. For females of childbearing potential, negative pregnancy test.\n8. Capable and willing to provide signed informed consent\n\nExclusion Criteria:\n\nCONCOMITANT PROCEDURES\n\n1. Patient had a recent MI, stroke, or cardiovascular accident; underwent coronary artery bypass graft surgery, had a percutaneous coronary intervention or other major cardiovascular surgery within 90 days prior to TricValve implantation.\n2. Patient requires another planned major cardiac procedure, including left-sided transcatheter intervention or surgery (e.g. severe aortic stenosis, severe mitral regurgitation), coronary artery bypass or PCI or pulmonary valve correction.\n\n   CARDIOVASCULAR CONDITIONS\n3. LVEF ≤ 30% on echocardiography.\n4. Evidence of intracardiac, inferior vena cava (IVC), or femoral venous mass, thrombus or vegetation.\n5. Severe right ventricular dysfunction.\n6. Cardiac amyloidosis.\n7. Pulmonary artery systolic pressure (PASP) \\>65 mmHg assessed with Echo Doppler and \u002For right heart catheterization.\n8. Lower extremity venous thrombosis and\u002For the presence of an IVC filter at the time of or 6 months prior to the TricValve procedure.\n9. Hemodynamically significant pericardial effusion.\n10. Hemodynamic instability, cardiogenic shock, inotropic support, intra-aortic balloon pump or acute heart failure within 30 days prior to the TricValve procedure.\n11. Patient with refractory heart failure requiring advanced intervention (i.e. left ventricular assist device, transplantation) (ACC\u002F AHA\u002F ESC\u002F EACTS Stage D heart failure).\n12. Presence of significant congenital or acquired heart disease such as RV dysplasia, arrhythmogenic RV or other conditions that could interfere with the TricValve procedure.\n\n    ALLERGIES \u002F INTOLERANCE\n13. Any known allergy or hypersensitivity to nitinol, bovine tissue, or contrast media that cannot be adequately treated with pre-medication.\n14. Unable to tolerate anticoagulation\u002Fantiplatelet therapy\n\n    COMORBIDITIES\n15. Any known life-threatening condition with an estimated life span of less than 12 months.\n16. Platelet count \\\u003C 75,000\u002Fmm3\n17. Child-Pugh Severity Class C (10-15 points).\n18. Severe renal insufficiency with estimated glomerular filtration rate (eGFR) ≤ 30 mL\u002Fmin\u002F1.73 m2 or requiring chronic renal replacement therapy at the time of enrollment.\n19. Endocarditis or active\u002Fongoing infection requiring antibiotics.\n20. Unable to walk at least 100 meters in a 6-minute walk test.\n21. Known bleeding or clotting disorders or patient refuses blood transfusion.\n22. Active gastrointestinal (GI) bleeding within 3 months of TricValve procedure.\n23. Prior Malignancy: this study excludes participants at material risk of near-term cancer-related morbidity\u002Fmortality that could confound 12-month outcomes. This study allows the inclusion of fully treated, remote malignancies with documented No Evidence of Disease (NED)\" criteria\n\n    a. History of any malignancy within 5 years prior to randomization or any active malignancy, except: i. Adequately treated non-melanoma skin cancer (basal or squamous cell) with no evidence of disease, or ii. Carcinoma in situ (e.g., cervical, breast DCIS) treated with curative intent and no evidence of disease.\n\n    b. Participants with a prior malignancy diagnosed \\>5 years before randomization are eligible if they meet all of the \"No Evidence of Disease (NED)\" criteria as specified below: i. No signs\u002Fsymptoms of cancer on history and physical exam per standard of care; ii. No radiologic evidence of disease on surveillance imaging if such imaging is routinely indicated for that tumor type (not protocol-mandated); iii. Tumor markers (if applicable for that cancer) not suggestive of recurrence (e.g., stable\u002Fundetectable within site's lab reference and oncologist's judgment); iv. No active anti-cancer therapy (cytotoxic chemotherapy, immunotherapy, targeted therapy, radiotherapy) and none planned; v. Treating oncologist's attestation (or primary physician if oncology follow-up is complete) that the participant is disease-free and appropriate for participation.\n\n    GENERAL EXCLUSIONS\n24. Use or participation in other investigational device or drug study in which the patient has not reached a primary endpoint to treat cardiovascular conditions related to the outcomes of the current study.\n25. Any other condition that would preclude the ability to meet study requirements in the opinion of the investigator.\n26. Psychiatric\u002Fbehavioral issues or other medical or social conditions that preclude valid consent and follow-up\n27. Pregnant or breastfeeding subjects and those who plan pregnancy during the clinical investigation follow-up period.\n\nEligibility Criteria for Single Arm Cohort:\n\nInclusion Criteria:\n\n1. Age \\> 85 years.\n2. NYHA Class III-IV, on intravenous inotropes, IABP or LVAD.\n3. LVEF ≤ 30% on echocardiography.\n4. Severe RV dysfunction.\n5. Severe pulmonary hypertension (PH), defined as Pulmonary artery systolic pressure (PASP) \\>65 mmHg assessed with Echo Doppler and \u002For mean Pulmonary Artery Pressure (mPAP \\>35) by right heart catheterization.\n6. Renal insufficiency: eGFR between 25 and 30 mL\u002Fmin\u002F 1.73 m² or on chronic renal replacement therapy.\n7. Patient unable to walk a minimum distance of 100 mt during 6 minute walk test.\n8. Prior malignancy not meeting the requirements applied for the Randomized Cohort, specified in Exclusion Criterion #23.\n9. Comorbidities precluding inclusion in the Randomized Cohort (exclusion criteria #15 to #24).","85 Years",{"count":113,"type":20},780,[23],"Pivotal trial to evaluate the safety and effectiveness of the P\\&F TricValve® Transcatheter Bicaval Valve System.",[56,26,87,117,118,55],"Heart Failure","Tricuspid Valve Regurgitation","NOT_YET_RECRUITING","2026-05-19",{"date":122,"type":31},"2026-05-22",{"date":124,"type":20},"2026-04",{"date":126,"type":20},"2032-11",{"name":128,"class":72},"P+F Products + Features USA Inc.",35,{"id":131,"slug":132,"hasResults":12,"nctId":133,"briefTitle":134,"officialTitle":135,"acronym":136,"eligibilityCriteria":137,"healthyVolunteers":138,"sex":16,"minAge":48,"maxAge":4,"enrollmentInfo":139,"targetDuration":4,"studyType":84,"phases":4,"briefSummary":141,"conditions":142,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":143,"lastUpdatePostDateStruct":144,"startDateStruct":146,"completionDateStruct":148,"leadSponsor":150,"locationsCount":151},"100627476","ai-assisted-screening-for-vhd-using-routine-chest-ct-scans-100627476","NCT07449130","AI Assisted Screening for VHD Using Routine Chest CT Scans","Artificial-Intelligence Assisted Opportunistic Screening for Valvular Heart Disease Using Non-contrast Chest CT Scans: A Prospective, Multicenter Study","ARTEMIS","Inclusion Criteria:\n\n1. Age ≥ 18 years.\n2. Complete electronic health record.\n3. Non-contrast chest CT performed between Nov 1, 2025 - Nov 1, 2026 in any medical context (including physical exam, outpatient, inpatient, or emergency).\n4. AI-predicted moderate or severe valvular heart disease, or deemed to require clinical intervention, or selected negative cases from sampling verification.\n\nExclusion Criteria:\n\n1. Poor-quality non-contrast chest CT images.\n2. Incomplete clinical records, involving severe deficiencies in critical diagnostic results, treatment records, imaging data, surgical records, medical history summaries, laboratory test results, or other essential medical information.\n3. Presence of prosthetic valve implants, including aortic valves (mechanical valves, bioprosthetic valves), mitral valves (transcatheter edge-to-edge repair, bioprosthetic valves, mechanical valves, annuloplasty rings), tricuspid valves (TEER clipping, bioprosthetic valves, mechanical valves, annuloplasty rings), pulmonary valves (bioprosthetic valves), etc.\n4. Abnormalities or conditions deemed by the investigator to warrant exclusion from the study enrollment.",true,{"count":140,"type":20},3000,"This is a prospective, multicenter study designed to validate a deep learning model for screening valvular heart diseases using routine, non-contrast chest computed tomography (CT) scans.\n\nThe primary objective is to evaluate the model's diagnostic performance, with the sensitivity serving as the primary efficacy endpoint. Secondary endpoints will include other performance metrics such as area under the receiver operating characteristic curve (AUC), specificity, and accuracy, etc.",[26],"2026-05-07",{"date":145,"type":31},"2026-05-12",{"date":147,"type":31},"2026-03-02",{"date":149,"type":20},"2026-11-01",{"name":102,"class":38},3,{"id":153,"slug":154,"hasResults":12,"nctId":155,"briefTitle":156,"officialTitle":157,"acronym":4,"eligibilityCriteria":158,"healthyVolunteers":138,"sex":16,"minAge":48,"maxAge":4,"enrollmentInfo":159,"targetDuration":4,"studyType":84,"phases":4,"briefSummary":161,"conditions":162,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":163,"lastUpdatePostDateStruct":164,"startDateStruct":166,"completionDateStruct":168,"leadSponsor":169,"locationsCount":39},"100636677","clinical-validation-of-portable-electronic-stethoscope-for-detecting-vhd-100636677","NCT07568795","Clinical Validation of Portable Electronic Stethoscope for Detecting VHD","Clinical Validation of Portable Electronic Stethoscope for Detecting Valvular Heart Disease","Inclusion Criteria:\n\n* Voluntarily agrees to participate by proving written informed consent\n* Have echocardiography done within 5 years\n\nExclusion Criteria:\n\n* Mechanical heart valve\n* Adult congenital heart disease",{"count":160,"type":20},125,"The goal of this observational study is to evaluate accuracy of portable electronic stethoscope and machine learning-based diagnostic algorithms for detecting the disease in people with valvular heart disease and healthy controls. The main question it aims to answer is:\n\nIs portable electronic stethoscope and machine learning-based diagnostic algorithms allow accurate detection of valvular heart disease?\n\nResearchers will compare diagnostic algorithm's predictions with the clinicians' predictions to see if the diagnostic results are accurate.\n\nParticipants will\n\n* take echocardiogram\n* take electrocardiogram using BPM Core\n* get the heart auscultation data measured via electronic stethoscope",[26],"2026-04-28",{"date":165,"type":31},"2026-05-06",{"date":167,"type":31},"2024-07-03",{"date":35,"type":20},{"name":170,"class":38},"The University of Hong Kong",{"id":172,"slug":173,"hasResults":12,"nctId":174,"briefTitle":175,"officialTitle":176,"acronym":177,"eligibilityCriteria":178,"healthyVolunteers":12,"sex":16,"minAge":48,"maxAge":4,"enrollmentInfo":179,"targetDuration":4,"studyType":21,"phases":180,"briefSummary":181,"conditions":182,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":183,"lastUpdatePostDateStruct":184,"startDateStruct":186,"completionDateStruct":188,"leadSponsor":190,"locationsCount":192},"100555042","the-tricure-efs-study-100555042","NCT06506942","The TRICURE EFS Study","The TRICURE EFS TRiCares Topaz Transfemoral TRICUspid Heart Valve REplacement System Early Feasibility Study","TRICURE EFS","Inclusion Criteria:\n\n* Adult patients\n* Tricuspid regurgitation grade 3 (severe) on a scale of 0 (none) to 5 (torrential)\n* Institutional Heart Team evaluates patient as being at increased operative risk\n\nExclusion Criteria:\n\n* Patient in need of emergent intervention\n* Patient who is hemodynamically unstable\n* Anatomical contraindications for implantation with study device\n* Patient who is currently participating in another clinical investigation where the primary endpoint was not reached yet",{"count":50,"type":20},[23],"Prospective, multi-center study to assess safety and performance of the TRiCares Topaz Tricuspid Valve Replacement System",[118,26,87],"2026-04-10",{"date":185,"type":31},"2026-04-14",{"date":187,"type":31},"2024-09-11",{"date":189,"type":20},"2031-03",{"name":191,"class":72},"TRiCares",9,{"id":194,"slug":195,"hasResults":12,"nctId":196,"briefTitle":197,"officialTitle":198,"acronym":4,"eligibilityCriteria":199,"healthyVolunteers":12,"sex":16,"minAge":48,"maxAge":4,"enrollmentInfo":200,"targetDuration":4,"studyType":21,"phases":202,"briefSummary":203,"conditions":204,"keywords":208,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":215,"lastUpdatePostDateStruct":216,"startDateStruct":218,"completionDateStruct":220,"leadSponsor":222,"locationsCount":224},"100296681","the-empower-trial---the-carillon-mitral-contour-system-in-treating-heart-failure-with-fmr-100296681","NCT03142152","The EMPOWER Trial - The Carillon Mitral Contour System® in Treating Heart Failure With FMR","Assessment of the Carillon Mitral Contour System® in Treating Heart Failure With Functional Mitral Regurgitation","Inclusion Criteria:\n\n1. Symptomatic heart failure with functional (secondary) mitral regurgitation of at least 1+ (mild) severity\n2. NYHA II, III, or IV\n3. Six Minute Walk distance ≥ 100 meters and ≤ 600 meters\n4. Left Ventricular Ejection Fraction ≤ 50%\n5. LVEDD:\n\n   * ≥ 55 mm (women)\n   * ≥ 57 mm (men)\n6. LVESD ≤ 75 mm\n7. Corrected NT-proBNP \\> 1200 pg\u002Fml measured within 60 days of randomization, and\u002For one or more heart failure hospitalizations within one year prior to consent or one or more outpatient visits for intensification of heart failure therapy within one year prior to consent.\n8. Optimal Guideline directed heart failure medical therapy assessed by the Central Review Committee\n9. Age ≥ 18 years old\n10. Carillon implant can be sized and placed in accordance with the IFU\n11. The subject has been informed of the nature of the trial and agrees to its provisions, including the possibility of randomization to the Control group and returning for all required post-procedure follow-up visits, and has provided written informed consent\n\nExclusion Criteria:\n\n1. Presence of a mechanical or bio-prosthetic mitral valve or, mitral valve annuloplasty, or leaflet repair device\n2. Significant organic mitral valve pathology (e.g., moderate or severe myxomatous degeneration, with or without mitral leaflet prolapse, rheumatic disease, full or partial chordal rupture)\n3. Severe tricuspid regurgitation associated with right ventricular dysfunction and enlargement\n4. Severe mitral annular calcification\n5. Severe aortic stenosis\n6. Expected to require any cardiac surgery, including surgery for coronary artery disease (CAD) or valve disease within one (1) year\n7. Chronic, severe, medical conditions or pathology, other than heart failure, that will prevent likely survival beyond twelve (12) months or any other medical condition that, in the judgement of the Investigator or Central Review Committee, makes the patient a poor candidate for this study\n\n   * An entire list of eligibility is available in the clinical investigational plan",{"count":201,"type":20},300,[23],"The objective of this prospective, randomized, double- blinded (patient and assessors), sham-controlled clinical trial is to assess the safety and efficacy of the CMCS in treating heart failure with functional regurgitation (FMR).",[205,117,206,207,87,26],"Functional Mitral Regurgitation","Mitral Valve Insufficiency","Heart Diseases",[205,209,210,211,212,213,214],"Percutaneous Mitral Valve Repair","Percutaneous Mitral Valve Annuloplasty","Coronary Sinus Annuloplasty","Secondary Mitral Regurgitation","Functional MR","FMR","2026-04-08",{"date":217,"type":31},"2026-04-13",{"date":219,"type":31},"2018-01-01",{"date":221,"type":20},"2030-12-31",{"name":223,"class":72},"Cardiac Dimensions, Inc.",92,{"id":226,"slug":227,"hasResults":12,"nctId":228,"briefTitle":229,"officialTitle":230,"acronym":231,"eligibilityCriteria":232,"healthyVolunteers":12,"sex":16,"minAge":48,"maxAge":4,"enrollmentInfo":233,"targetDuration":4,"studyType":21,"phases":235,"briefSummary":236,"conditions":237,"keywords":242,"overallStatus":119,"whyStopped":4,"lastUpdateSubmitDate":245,"lastUpdatePostDateStruct":246,"startDateStruct":247,"completionDateStruct":249,"leadSponsor":251,"locationsCount":4},"100632650","vdyne-transcatheter-tricuspid-valve-replacement-study-to-evaluate-safety-and-clinical-efficacy-in-patients-with-symptomatic-severe-tricuspid-valve-regurgitation-trivita-pivotal-trial-100632650","NCT07516444","VDyne Transcatheter Tricuspid Valve Replacement Study to Evaluate Safety and Clinical Efficacy in Patients With Symptomatic Severe Tricuspid Valve Regurgitation (TRIVITA Pivotal Trial)","VDyne Transcatheter Tricuspid Valve Replacement Study to Evaluate Safety and Clinical Efficacy in Patients With Symptomatic Severe Tricuspid Valve Regurgitation","TRIVITA","Inclusion Criteria:\n\n* Age ≥18 years old\n* Subject is willing and able to comply with all study evaluations and provide consent\n* Subject must agree not to participate in any other clinical trial for a period of one year following index procedure\n* New York Heart Association (NYHA) Functional Class II, III, or IV and ambulatory\n* At least severe symptomatic tricuspid regurgitation.\n* Despite adequate and Optimized Medical Therapy (OMT), subject has signs and symptoms from TR, or prior heart failure hospitalization from TR\n* Heart team determines that the subject is appropriate for transcatheter tricuspid valve replacement\n* Functional and\u002For degenerative TR graded as at least severe\n\nExclusion Criteria:\n\n* Subject unable or unwilling to comply with study required testing and follow-up visits\n* Subject is currently participating in another clinical trial (drug, biologic, or device) that has not yet completed its primary endpoint or is likely to interfere with this study\n* Pregnant, lactating subjects, and \u002For those who plan pregnancy in the period up to one year following index procedure.\n* Known hypersensitivity or contraindication to procedural or post-procedural medications (e.g., contrast solution, anticoagulation, etc.) which cannot be adequately managed medically\n* Life expectancy ≤12 months due to non-cardiac comorbidities\n* Current IV Drug user (must be free from drug abuse for ≥1 year)\n* Subject unable or unwilling to provide written, informed consent before study enrollment\n* Tricuspid valve anatomy (cardiac and vascular) that is not suitable for the VDyne System\n* Hypersensitivity to metals (such as nickel or titanium)\n* Prior tricuspid valve surgery or catheter-based therapy with permanent residual device(s) implanted that would preclude delivery or implantation of the VDyne valve (e.g., valve replacement, edge to edge repair, etc.)\n* Severe valvular heart disease using established echocardiographic criteria requiring intervention other than the tricuspid valve\n* Known significant intracardiac shunt (e.g., septal defect).\n* Cerebrovascular accident (stroke, TIA) within 90 days of treatment procedure\n* Severe lung disease (severe COPD) or continuous use of home oxygen or oral steroids\n* Acute myocardial infarction (AMI) within 30 days of SSC determination of eligibility\n* Leukopenia, chronic anemia (Hgb \\\u003C 9 g\u002FdL), current thrombocytopenia (platelets \\\u003C70\u002FmcL), history of bleeding diathesis, or coagulopathy\n* Unwilling to receive blood products\n* Deep vein thrombosis and\u002For pulmonary embolism in the last 6-months",{"count":234,"type":20},730,[23],"Pivotal trial to evaluate the safety and clinical efficacy of the VDyne System for the treatment of symptomatic severe or greater tricuspid regurgitation.",[118,56,238,26,55,239,240,241],"Cardiovascular Diseases (CVD)","Severe Heart Valve Disease","Randomized Controlled Trial (RCT)","Symptomatic Tricuspid Regurgitation",[243,231,244,54],"VDyne","TRIVITA Pivotal","2026-03-31",{"date":215,"type":31},{"date":248,"type":20},"2026-06",{"date":250,"type":20},"2036-06",{"name":252,"class":72},"VDyne, Inc.",{"id":254,"slug":255,"hasResults":12,"nctId":256,"briefTitle":257,"officialTitle":257,"acronym":258,"eligibilityCriteria":259,"healthyVolunteers":12,"sex":16,"minAge":260,"maxAge":4,"enrollmentInfo":261,"targetDuration":4,"studyType":84,"phases":4,"briefSummary":262,"conditions":263,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":265,"lastUpdatePostDateStruct":266,"startDateStruct":268,"completionDateStruct":270,"leadSponsor":272,"locationsCount":39},"100455286","london-valvular-heart-disease-and-reduced-ejection-fraction-detection-in-a-multi-ethnic-community-using-cardiac-ultrasound-100455286","NCT05208567","London Valvular Heart Disease and Reduced Ejection Fraction Detection in a Multi-ethnic Community Using Cardiac Ultrasound","LOVE","Inclusion Criteria:\n\n\\- Greater or equal to 65 years old\n\nExclusion Criteria:\n\n* Clinical diagnosis of Alzheimer's Disease or Vascular Dementia\n* Palliative Care patients.","65 Years",{"count":19,"type":20},"Heart Valve Disease and Heart failure contribute to 25% of hospital emergency admissions while heart failure alone has become one of the most common causes for hospitalisation in people over the age of 65. The burden of disease is likely to be high in a multi-ethnic community but there is a paucity of data. Management of heart valve disease requires appropriate surveillance and timely surgery. Similarly heart failure management requires treatment with medications aimed at slowing prevention of symptoms and preventing premature death. The NHS long term plan priorities early detection and treatment of valve disease and heart failure in order to reduce the burden on emergency services and improve the health of the population.\n\nDiagnosis is made using cardiac ultrasound, however staff with the required skills-set are critically limited in the community.\n\nThe investigators will train non-expert staff within primary care to perform abbreviated cardiac ultrasound to detect heart valve disease or heart failure. This will be opportunistic scanning to reduce healthcare footfall.\n\nAll scans will be reviewed by an expert and the investigators will use the anonymised data to develop machine learning tools to begin working with academic partners to develop tools that can improve the reliability of diagnosis from ultrasound.\n\nThe investigators hope to identify the proportion with the above conditions in a multi-ethnic community and assess the feasibility of developing a program where staff can be trained for community detection, streamlined referrals can be created bridging the gap between primary and secondary care, reducing hospital emergency admissions, while ensuring patients are managed optimally.",[26,264],"Left Ventricular Dysfunction","2026-02-19",{"date":267,"type":31},"2026-02-23",{"date":269,"type":31},"2023-03-14",{"date":271,"type":20},"2026-09-02",{"name":273,"class":38},"Queen Mary University of London",{"id":275,"slug":276,"hasResults":12,"nctId":277,"briefTitle":278,"officialTitle":279,"acronym":4,"eligibilityCriteria":280,"healthyVolunteers":12,"sex":16,"minAge":48,"maxAge":4,"enrollmentInfo":281,"targetDuration":4,"studyType":84,"phases":4,"briefSummary":283,"conditions":284,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":290,"lastUpdatePostDateStruct":291,"startDateStruct":293,"completionDateStruct":294,"leadSponsor":296,"locationsCount":299},"100622998","gls-in-difficult-cpb-weaning-100622998","NCT07390903","GLS in Difficult CPB Weaning","Global Longitudinal Strain as a Predictor of Difficult Separating From Cardiopulmonary Bypass","Inclusion Criteria\n\n* Age \\> 18 years.\n* Scheduled for elective cardiac surgery requiring cardiopulmonary bypass (CPB).\n* Provided written informed consent to participate.\n* Eligible surgical procedures include:\n\n  * Isolated mitral valve replacement or repair.\n  * Isolated aortic valve replacement or repair.\n  * Isolated coronary artery bypass grafting (CABG).\n  * Combined valve and CABG surgery.\n  * Multiple valve replacement or repair.\n  * Surgery involving the ascending aorta or aortic arch.\n\nExclusion Criteria\n\n* Emergency cardiac surgery.\n* Redo cardiac surgery.\n* Contraindications to transesophageal echocardiography (TEE).\n* Critical preoperative conditions, including:\n\n  * Ongoing inotropic drug therapy.\n  * Preoperative mechanical circulatory support (e.g., IABP, ECMO, VAD).\n  * Requirement for mechanical ventilation.\n  * Preoperative atrial fibrillation.",{"count":282,"type":20},213,"The goal of this observational study is to learn whether global longitudinal strain (GLS), measured by echocardiography, can predict difficulty separating from cardiopulmonary bypass (CPB) in adults undergoing elective cardiac surgery.\n\nThe main questions it aims to answer are:\n\n* Can preoperative GLS measurement predict difficult separation from CPB?\n* Are GLS values associated with outcomes such as intensive care unit (ICU) stay, hospital stay, cardiac biomarkers, or 30-day mortality?\n\nParticipants will:\n\n* Undergo standard cardiac surgery requiring CPB\n* Have echocardiographic assessments (TTE before and after surgery)\n* Have their recovery and outcomes monitored, including ICU and hospital stay, postoperative labs, and survival within 30 days",[285,286,26,287,288,289],"Cardiopulmonary Bypass","Coronary Artery Bypass","Echocardiography","Intraoperative Complications","Postoperative Complications (Cardiopulmonary)","2026-02-01",{"date":292,"type":31},"2026-02-05",{"date":292,"type":20},{"date":295,"type":20},"2026-08-30",{"name":297,"class":298},"Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital","OTHER_GOV",2,{"id":301,"slug":302,"hasResults":12,"nctId":303,"briefTitle":304,"officialTitle":305,"acronym":306,"eligibilityCriteria":307,"healthyVolunteers":12,"sex":16,"minAge":308,"maxAge":4,"enrollmentInfo":309,"targetDuration":4,"studyType":84,"phases":4,"briefSummary":311,"conditions":312,"keywords":314,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":318,"lastUpdatePostDateStruct":319,"startDateStruct":321,"completionDateStruct":323,"leadSponsor":325,"locationsCount":327},"100349165","transpacific-tavr-registry-100349165","NCT03826264","Transpacific TAVR Registry","a Multinational Multicenter Prospective Transpacific TAVR Registry","TP-TAVR","Inclusion Criteria:\n\n* All patients undergoing TAVR\n* Informed consent","19 Years",{"count":310,"type":20},10000,"This registry evaluates the long-term outcome of Transcatheter aortic valve replacement (TAVR) in real-world clinical practice.",[26,313],"Aortic Valve Insufficiency",[315,316,317],"TAVR","TAVI","real-world","2025-12-28",{"date":320,"type":31},"2026-01-02",{"date":322,"type":31},"2019-06-15",{"date":324,"type":20},"2036-12-31",{"name":326,"class":38},"Duk-Woo Park, MD",7,{"id":329,"slug":330,"hasResults":12,"nctId":331,"briefTitle":332,"officialTitle":333,"acronym":334,"eligibilityCriteria":335,"healthyVolunteers":138,"sex":16,"minAge":260,"maxAge":4,"enrollmentInfo":336,"targetDuration":4,"studyType":21,"phases":338,"briefSummary":339,"conditions":340,"keywords":341,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":344,"lastUpdatePostDateStruct":345,"startDateStruct":347,"completionDateStruct":349,"leadSponsor":351,"locationsCount":39},"100550296","echocardiography-in-nursing-home-100550296","NCT06445231","Echocardiography in Nursing Home","Implementation and Effectiveness of Screening Echocardiography Performed in Nursing Home: ECHOGER","ECHOGER","Inclusion Criteria :\n\nNursing homes residents with a life-expectancy estimated \\> 1 year, and able to participate to the study, giving an oral consent\n\nExclusion Criteria :\n\n* no accessible to echocardiography\n* closed unit (severe Alzheimer disease…)\n* recent contagious disease such Covid (\\\u003C15 days)\n* no consent to participate\n* no social security number",{"count":337,"type":20},1050,[23],"The study seeks to explore the implementation characteristics (acceptability, appropriateness, feasibility, adoption, fidelity, penetration, implementation cost and sustainability) of systematic echocardiography in nursing homes and its impact on rates of heart failure flare-up and unscheduled hospitalization at 12 months among included nursing homes.",[207,117,26],[287,342,343,117],"Nursing Home","Implementation","2025-12-02",{"date":346,"type":31},"2025-12-03",{"date":348,"type":31},"2024-10-02",{"date":350,"type":20},"2030-01-01",{"name":352,"class":38},"Nantes University Hospital",{"id":354,"slug":355,"hasResults":12,"nctId":356,"briefTitle":357,"officialTitle":358,"acronym":4,"eligibilityCriteria":359,"healthyVolunteers":12,"sex":16,"minAge":308,"maxAge":4,"enrollmentInfo":360,"targetDuration":4,"studyType":21,"phases":362,"briefSummary":364,"conditions":365,"keywords":4,"overallStatus":119,"whyStopped":4,"lastUpdateSubmitDate":370,"lastUpdatePostDateStruct":371,"startDateStruct":373,"completionDateStruct":375,"leadSponsor":377,"locationsCount":39},"100611314","phase-4-postoperative-intravenous-ferric-derisomaltose-for-prevention-of-long-term-anemia-after-cardiac-surgery-100611314","NCT07238972","Postoperative Intravenous Ferric Derisomaltose for Prevention of Long-term Anemia After Cardiac Surgery","Impact of Postoperative Intravenous Iron Supplementation on the Incidence of Long-term Anemia in Patients Undergoing Cardiac Surgery","Inclusion Criteria:\n\n* Adults aged ≥19 years scheduled to undergo cardiac surgery requiring cardiopulmonary bypass Preoperative anemia defined as hemoglobin \\\u003C13.0 g\u002FdL, or preoperative iron deficiency defined as ferritin \\\u003C100 ng\u002FmL or transferrin saturation \\\u003C20% Ability to understand the study information and provide written informed consent prior to surgery\n\nPostoperative day 1 hemoglobin \\\u003C10.0 g\u002FdL on the first CBC following surgery (required for final enrollment)\n\nExclusion Criteria:\n\n* Emergency surgery Preoperative major organ failure requiring intensive care unit management Active infection prior to surgery, including sepsis Active bleeding prior to surgery Pregnancy or breastfeeding Use of erythropoiesis-stimulating agents or intravenous iron therapy within 3 months prior to surgery Iron overload defined as ferritin ≥500 ng\u002FmL or transferrin saturation ≥45% Aplastic anemia Hemolytic anemia Hemochromatosis or hemosiderosis Decompensated liver cirrhosis, acute hepatitis, or alcohol dependence Known hypersensitivity to intravenous iron formulations Participation in another clinical trial that may influence outcomes Inability to understand or provide informed consent due to language barriers, illiteracy, or cognitive impairment",{"count":361,"type":20},180,[363],"PHASE4","Postoperative anemia is highly prevalent among patients undergoing cardiac surgery and is associated with delayed functional recovery, increased morbidity, and impaired long-term outcomes. Preoperative iron deficiency is common in this population and contributes to inadequate erythropoietic recovery after surgery. Functional iron deficiency frequently develops even in patients without preoperative deficiency due to blood loss, hemodilution, and inflammation-mediated disruption of iron homeostasis. Despite this clinical burden, standardized strategies for postoperative anemia management have not been established.\n\nThis prospective, randomized, double-blind, placebo-controlled clinical trial evaluates whether early postoperative intravenous iron supplementation improves long-term anemia outcomes in patients undergoing cardiac surgery with cardiopulmonary bypass. Adult patients with preoperative anemia (hemoglobin \\\u003C13 g\u002FdL) or iron deficiency (ferritin \\\u003C100 ng\u002FmL or transferrin saturation \\\u003C20%) will be screened. Eligible participants with postoperative day (POD) 1 hemoglobin \\\u003C10 g\u002FdL will be randomized in a 1:1 ratio to receive either ferric derisomaltose (20 mg\u002Fkg, maximum 1,000 mg) or a matched placebo administered intravenously over 30 minutes on POD 1. All perioperative management outside the intervention follows current institutional standards.\n\nThe primary outcome is the incidence of anemia at 6 months following surgery. Secondary outcomes include perioperative hemoglobin trends, functional recovery assessed by cardiopulmonary exercise testing and the 6-minute walk test at 6 months, transfusion requirements, postoperative complications including MAKE-90 and STS major morbidity, and changes in biomarkers of erythropoiesis and iron metabolism (erythroferrone, erythropoietin, hepcidin, and iron profile). Blood samples for biomarker analysis are collected at predefined perioperative timepoints.\n\nFerric derisomaltose allows high-dose single-session iron repletion with a favorable safety profile and minimal risk of anaphylaxis when administered slowly. Prior studies in cardiac surgery and heart failure populations support its efficacy and safety at doses up to 20 mg\u002Fkg. The intervention is expected to facilitate erythropoietic recovery, reduce the duration of postoperative anemia, and improve long-term functional status. The trial aims to generate evidence to inform postoperative anemia management strategies in cardiac surgery patients.",[366,367,368,369,26],"Anemia","Iron Deficiencies","Iron Deficiency Anemia","Cardiac Surgery","2025-11-16",{"date":372,"type":31},"2025-11-20",{"date":374,"type":20},"2025-12",{"date":376,"type":20},"2030-10",{"name":378,"class":38},"Yonsei University",{"id":380,"slug":381,"hasResults":12,"nctId":382,"briefTitle":383,"officialTitle":383,"acronym":4,"eligibilityCriteria":384,"healthyVolunteers":12,"sex":16,"minAge":48,"maxAge":4,"enrollmentInfo":385,"targetDuration":4,"studyType":21,"phases":387,"briefSummary":388,"conditions":389,"keywords":395,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":397,"lastUpdatePostDateStruct":398,"startDateStruct":400,"completionDateStruct":402,"leadSponsor":404,"locationsCount":406},"100510949","mcnair-study-comparative-effectiveness-of-in-person-and-telehealth-cardiac-rehabilitation-100510949","NCT05933083","MCNAIR Study: coMparative effeCtiveness of iN-person and teleheAlth cardIac Rehabilitation","Inclusion Criteria:\n\n1. Age 18 or older\n2. Eligible for cardiac rehabilitation\n\n   1. Diagnosis within 1 year prior to consent\n\n      * Myocardial infarction\n      * Percutaneous coronary intervention\n      * Coronary artery bypass\n      * Heart valve repair or replacement\n      * Heart transplant\n   2. Chronic stable angina, or\n   3. Chronic systolic heart failure (ejection fraction ≤ 35%)\n   4. Referred to cardiac rehabilitation by a doctor or advanced practice provider for another indication that is covered by the participant's insurance, such as heart failure with preserved ejection fraction or aortic surgery.\n3. Willing to be randomized to in-person or telehealth cardiac rehabilitation\n4. Able to communicate in English or Spanish\n\nExclusion Criteria:\n\n1. Unstable arrhythmias which may make unmonitored exercise unsafe (e.g., history of ventricular tachycardia not on medical therapy and without an implantable cardioverter defibrillator)\n2. Unsafe for patient to participate in the opinion of the investigator\n3. Hospice\n4. Unable to consent for self",{"count":386,"type":20},516,[23],"Cardiac rehabilitation is a medically recommended program for patients with certain heart conditions. It includes exercise training, health education, and counseling. Unfortunately, many patients do not participate in cardiac rehabilitation. Some find it challenging to attend the in-person sessions. This study aims to compare two methods of delivering cardiac rehabilitation: in-person and through telehealth. The investigators want to know if the effects of these two programs are alike and if certain individuals benefit more from one program over the other.",[390,391,26,392,393,394],"Myocardial Infarction","Heart Failure, Systolic","Angina, Stable","Coronary Artery Disease","Heart Transplant",[396],"cardiac rehabilitation, telehealth","2025-09-09",{"date":399,"type":31},"2025-09-11",{"date":401,"type":31},"2023-10-27",{"date":403,"type":20},"2027-10-15",{"name":405,"class":38},"University of California, San Francisco",5,{"id":408,"slug":409,"hasResults":12,"nctId":410,"briefTitle":411,"officialTitle":412,"acronym":413,"eligibilityCriteria":414,"healthyVolunteers":12,"sex":16,"minAge":48,"maxAge":4,"enrollmentInfo":415,"targetDuration":4,"studyType":21,"phases":417,"briefSummary":419,"conditions":420,"keywords":422,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":427,"lastUpdatePostDateStruct":428,"startDateStruct":430,"completionDateStruct":432,"leadSponsor":434,"locationsCount":39},"100532636","phase-3-antagonization-of-heparin-with-protamine-sulfate-after-tavi-100532636","NCT06215378","Antagonization of Heparin With Protamine Sulfate After TAVI","Antagonization of Heparin With Protamine Sulfate to Lower All Neurological Ischemic and Hemorrhagic Events After Transcatheter Aortic Valve Implantation for Aortic Stenosis","ATLANTIS-Prota","Inclusion Criteria:\n\n* Men and women ≥18 years of age\n* Any patient eligible for transfemoral TAVI, irrespective of the chronic antithrombotic treatment\n* Written informed consent\n* Registered at the French social healthcare\n\nExclusion Criteria:\n\n* Any major protamine sulfate exposure contraindications defined as a history of severe pulmonary hypertension, acute pulmonary edema or history of bronchospasm related to protamine sulfate administration\n* Known allergy to protamine sulfate\n* Hypersensitivity to protamine sulfate including protamine contained as an excipient in NPH \\[Neutral Protamine Hagedorn\\] insulin, known protamine or protamine-heparine complex antibodies\n* Non-femoral approach for the TAVI procedure\n* Protamine sulfate exposure within 24h of randomization\n* Fish allergy\n* Mechanical valves\n* For men: Sterile or Vasectomy\n* Women of childbearing potential\n* Pregnancy and breast feeding women\n* Contemporaneous enrolment in an interventional clinical trial\n* Patient under guardianship or curatorship",{"count":416,"type":20},940,[418],"PHASE3","Transcatheter aortic valve replacement (TAVR) is now the first therapeutic option offered to high and intermediate risk patients with symptomatic aortic stenosis but even to low-risk, when the aortic valve is tricuspid and the transfemoral approach is suitable. Vascular and bleeding complications are the most frequent procedure-related unwanted events associated with increased short-term morbidity and mortality. Selection of the appropriate vascular access site and pre-closing devices as well as stent implantation mitigate these complications.\n\nACT-guided heparin reaching a target of 300 seconds or more is recommended prior to the placement of the guiding sheath in the common femoral artery. Protamine sulfate is the heparin antidote, which antagonizes 100% of its anti-IIa activity and 60% of its anti-Xa activity. Reversal of heparin using protamine sulfate is recommended for transapical and complicated transfemoral aortic valve placement.However, there is a great heterogeneity of protamine use in daily practice and supportive evidence for the prevention of bleeding complications as well as its safety is lacking. In addition, the radial approach for the second vascular access is more commonly used as well as the use of echo-guided femoral puncture further questioning reversal of heparin when the procedure has been successfully completed without overt bleeding complications.\n\nOur study aims to demonstrate the superiority of a strategy of systematic ACT-guided heparin administration followed by systematic antagonization with protamine sulfate over usual of care to reduce in-hospital mortality, vascular\u002Fbleeding complications, stroke and transcient ischemic attack, myocardial infarction or red blood cell transfusion, from randomization to hospital discharge",[421,26],"Aortic Valve Stenosis",[316,423,424,425,426],"Protamine","Heparine","Antagonization","Aortic stenosis","2025-08-18",{"date":429,"type":31},"2025-08-22",{"date":431,"type":31},"2025-05-25",{"date":433,"type":20},"2027-03-01",{"name":435,"class":38},"Assistance Publique - Hôpitaux de Paris",{"id":437,"slug":438,"hasResults":12,"nctId":439,"briefTitle":440,"officialTitle":441,"acronym":442,"eligibilityCriteria":443,"healthyVolunteers":12,"sex":16,"minAge":48,"maxAge":111,"enrollmentInfo":444,"targetDuration":4,"studyType":21,"phases":446,"briefSummary":447,"conditions":448,"keywords":453,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":463,"lastUpdatePostDateStruct":464,"startDateStruct":466,"completionDateStruct":468,"leadSponsor":470,"locationsCount":39},"100600620","phase-4-effect-of-losartan-on-the-neurohumoral-axis-and-ventricular-remodeling-of-patients-with-severe-aortic-regurgitation-undergoing-valve-surgery-100600620","NCT07099859","Effect of Losartan on the Neurohumoral Axis and Ventricular Remodeling of Patients With Severe Aortic Regurgitation Undergoing Valve Surgery.","Effect of Losartan on the Neurohumoral Axis and Ventricular Remodeling of Patients With Severe Aortic Regurgitation Undergoing Valve Surgery","ARBNP","Inclusion criteria:\n\n* Age ≥ 18 years;\n* Postoperative period of aortic valve replacement surgery due to severe aortic regurgitation of any etiology;\n* Signed Informed Consent Form.\n\nExclusion Criteria:\n\nTo avoid potential bias in data interpretation, the following patients will be excluded:\n\n* Those who underwent cardiac surgery in the context of cardiogenic shock or infective endocarditis;\n* Patients with ischemic cardiomyopathy;\n* Patients with other significant concomitant valvular diseases.\n\nPatients with conditions where losartan use may be harmful will also be excluded, including:\n\n* Chronic kidney disease with an estimated glomerular filtration rate (eGFR \\\u003C 30 ml\u002Fmin\u002F1.73 m²);\n* Systolic blood pressure (SBP) \\\u003C 90 mmHg at the time of randomization;\n* Elevated serum potassium (K \\> 5.5 mEq\u002FL) at the time of randomization;\n* Pregnancy;\n* Known intolerance or allergy to losartan.",{"count":445,"type":20},60,[363],"Why Is This Study Important? The heart has valves that help control blood flow. Aortic regurgitation (AR) is a condition where one of these valves (the aortic valve) doesn't close properly, causing blood to leak back into the heart. Over time, this makes the heart work harder and grow larger (remodeling) to keep up. Many patients with severe AR need valve replacement surgery to fix this problem.\n\nAfter surgery, the heart doesn't have to work as hard, and over time, it can shrink back to a healthier size (reverse remodeling). However, doctors don't know if medications can help speed up or improve this healing process. This study aims to find out if a common blood pressure medication, losartan, can help the heart recover better after surgery.\n\nWhat Do the Investigators Already Know? Doctors often prescribe medications like ACE inhibitors, angiotensin receptor blockers (ARBs), beta-blockers, and spironolactone to people with heart failure because these drugs help the heart function better and prevent worsening disease. However, these medications haven't been studied in people with valve disease because most major research studies excluded patients with valve problems.\n\nEven though there is not strong evidence, many doctors prescribe these medications after valve surgery, assuming they might be helpful. But is that really the case? That's the question this study hopes to answer.\n\nWhat Is This Study About?\n\nThis study will test whether losartan, a medication often used for high blood pressure, can help hearts recover better after aortic valve replacement surgery. The researchers will compare two groups of patients:\n\n* One group will take losartan (50 mg per day) after surgery.\n* The other group will take a placebo (a pill with no active medication).\n\nBy comparing these two groups, the study will determine whether losartan helps the heart shrink back to a normal size faster and function better after surgery.\n\nHow Will the Study Work? Who? 60 patients with severe AR who are having aortic valve replacement surgery.\n\nHow? Patients will be randomly placed into one of the two groups (losartan or placebo).\n\nFor how long? Patients will be followed for one year after surgery. What Will Be Measured?\n\nDoctors will check patients four times: before surgery, and 1 month, 3 months, and 12 months after surgery. At each visit, the investigators will measure:\n\n* NT-proBNP levels: A blood test that tells us how much strain the heart is under. Lower levels mean the heart is recovering well.\n* Echocardiogram: An ultrasound of the heart to check its size and function.\n* 6-minute walk test: To see if patients feel stronger and can exercise better.\n* Quality of life survey: To understand how patients feel physically and emotionally.\n* Kidney function and electrolyte levels: To check for medication side effects.\n\nWhy Is This Study Exciting? This is the first study to test whether a medication can help the heart heal better after valve surgery. If losartan proves beneficial, it could change how doctors treat patients after surgery and lead to better recovery, stronger hearts, and healthier lives.\n\nMany people with aortic regurgitation have to wait until their symptoms get worse before patients can have surgery. If this study finds that medication can speed up healing, it could help doctors treat valve disease more effectively and improve long-term outcomes for patients.\n\nWhat Happens Next? If losartan is found to be helpful, this study could lead to larger research trials and, eventually, new treatment guidelines for people who have had aortic valve surgery. If it doesn't help, doctors will know not to prescribe it unnecessarily, preventing unnecessary side effects and costs for patients. Either way, the results will help improve care for people with heart valve disease.\n\nBy participating in this study, patients are helping researchers discover new ways to improve heart health and recovery after surgery.",[26,449,450,451,452],"Left Ventricle Remodeling","Aortic Regurgitation Disease","Heart Failure Congestive","Natriuretic Peptide, Brain",[454,455,456,457,458,459,460,461,462],"aortic regurgitation","valve disease","heart surgery","heart failure","losartan","Brain natriuretic peptide - BNP","biomarkers","renin-angiotensin-aldosterone system","neurohumoral axis","2025-07-29",{"date":465,"type":31},"2025-08-01",{"date":467,"type":31},"2025-07-01",{"date":469,"type":20},"2029-07-01",{"name":471,"class":38},"Vitor Emer Egypto Rosa",{"id":473,"slug":474,"hasResults":12,"nctId":475,"briefTitle":476,"officialTitle":476,"acronym":4,"eligibilityCriteria":477,"healthyVolunteers":12,"sex":16,"minAge":308,"maxAge":4,"enrollmentInfo":478,"targetDuration":4,"studyType":84,"phases":4,"briefSummary":480,"conditions":481,"keywords":4,"overallStatus":119,"whyStopped":4,"lastUpdateSubmitDate":485,"lastUpdatePostDateStruct":486,"startDateStruct":488,"completionDateStruct":490,"leadSponsor":492,"locationsCount":39},"100598218","korea-vhd-echo-study-surveillance-of-aortic-mitral--tricuspid-patients---insights-from-real-world-practice-100598218","NCT07068633","Korea VHD Echo Study: Surveillance of Aortic, Mitral & Tricuspid Patients - Insights From Real-world Practice","Inclusion Criteria:\n\n* Period: 2010.1.1\\~2020.12.31\n* Age \\> 18 years\n* Moderate or severe native VHD (AS, AR, MR and TR)\n* Perform echocardiography more than twice\n\nExclusion Criteria:\n\n* Poor image of echocardiography\n* Follow up loss",{"count":479,"type":20},30000,"Valvular heart disease (VHD) is a growing public health concern globally, with increasing disease burden and rising interest in advanced treatment strategies such as transcatheter interventions. However, there remains a significant lack of real-world data regarding echocardiography practices, disease prevalence and progression, referral patterns, and treatment pathways. Addressing these gaps is critical for improving patient care and informing clinical decision-making.\n\nSouth Korea provides a unique opportunity to conduct a nationwide retrospective echocardiographic study due to its advanced healthcare infrastructure, high patient volume, and strong tradition in clinical research. The current study aims to evaluate the real-world burden and clinical journey of patients with moderate or severe valvular disease over a 10-year period, based on echocardiographic and electronic medical record (EMR) data collected from multiple tertiary centers across the country.",[26,421,313,206,482,55,483,484],"Mitral Valve Prolapse","Rheumatic Heart Disease","Aortic Diseases","2025-07-07",{"date":487,"type":31},"2025-07-16",{"date":489,"type":20},"2025-08",{"date":491,"type":20},"2027-12-31",{"name":378,"class":38},{"id":494,"slug":495,"hasResults":12,"nctId":496,"briefTitle":497,"officialTitle":498,"acronym":4,"eligibilityCriteria":499,"healthyVolunteers":12,"sex":16,"minAge":48,"maxAge":500,"enrollmentInfo":501,"targetDuration":503,"studyType":84,"phases":4,"briefSummary":504,"conditions":505,"keywords":507,"overallStatus":119,"whyStopped":4,"lastUpdateSubmitDate":510,"lastUpdatePostDateStruct":511,"startDateStruct":513,"completionDateStruct":515,"leadSponsor":517,"locationsCount":4},"100570152","an-exploratory-clinical-study-to-evaluate-the-safety-and-efficacy-of-a-cardiac-surgical-cryoablation-system-for-the-treatment-of-atrial-fibrillation-100570152","NCT06703528","An Exploratory Clinical Study to Evaluate the Safety and Efficacy of a Cardiac Surgical Cryoablation System for the Treatment of Atrial Fibrillation","Cryoablation System with Liquid Nitrogen for the Treatment of Atrial Fibrillation","Inclusion Criteria:\n\n* patients with valvular disease (e.g., mitral, tricuspid, and aortic valve disease) requiring surgical intervention;\n* patients with atrial fibrillation who consent to cryoablation;\n* 18-75 years of age (as of the date of signing the informed consent form);\n* signing the patient's informed consent.\n\nExclusion Criteria:\n\n* intracardiac thrombosis;\n* patients with absolute contraindications to anticoagulation;\n* combination of other cardiac diseases requiring surgical treatment;\n* patients with a diagnosis of coronary artery disease (coronary artery enhancement CT or coronary angiography suggesting that any one of the three coronary vessels and their major branches has a stenosis greater than or equal to 50%);\n* patients with generalized malignant disease or severe insufficiency of liver, kidney, heart and lung functions;\n* patients with current active infection;\n* pregnant and lactating patients;\n* patients with a prior history of cardiac surgery;\n* patients with myocardial infarction within the last 3 months;\n* patients who have suffered a stroke within the last 3 months;\n* patients with an anterior-posterior left atrial diameter greater than 70 mm;\n* left ventricular ejection fraction (LVEF) \\\u003C50%;\n* patients who are not expected to complete the 6-month postoperative follow-up;\n* those who are participating in other clinical trials and have not met the primary endpoint;\n* those who, in the opinion of the investigator, are not suitable for participation in this clinical study.","75 Years",{"count":502,"type":20},10,"6 Months","The goal of this prospective, observational study is to evaluate the safety and efficacy of a cardiac surgical cryoablation system for the treatment of atrial fibrillation. This study will be conducted at Fuwai Hospital in China. A total of 10 subjects with heart valve diseases (e.g., mitral, tricuspid, and aortic valve diseases) requiring surgical treatment and with atrial fibrillation will be enrolled in the study, and all of them will undergo surgical ablation using surgical cryoablation devices (cryoablation clamps and pens) with follow-up visits at 3 and 6 months after the procedure. In this study, the incidence of cardiac and cerebrovascular-related adverse events in the perioperative period and at 6 months after procedure is defined as the primary safety endpoint (all-cause mortality, stroke, systematic embolism, cardiac reoperations, heart failure requiring hospitalization, ablation-related coronary artery stenosis\u002Focclusion, pulmonary vein stenosis, and rate of permanent pacemaker implantation.). The primary efficacy endpoint is the probability of freedom from atrial tachyarrhythmias at 6 months after the procedure. Device ease of use, technical success, ablation procedure time, and assessment of the incidence of device defects are defined as secondary endpoints.",[506,26],"Atrial Fibrillation (AF)",[508,509],"atrial fibrillation","heart valve diseases","2024-11-20",{"date":512,"type":31},"2024-11-25",{"date":514,"type":20},"2025-06",{"date":516,"type":20},"2026-08",{"name":518,"class":298},"China National Center for Cardiovascular Diseases",{"id":520,"slug":521,"hasResults":12,"nctId":522,"briefTitle":523,"officialTitle":524,"acronym":4,"eligibilityCriteria":525,"healthyVolunteers":12,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":526,"targetDuration":4,"studyType":84,"phases":4,"briefSummary":527,"conditions":528,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":529,"lastUpdatePostDateStruct":530,"startDateStruct":532,"completionDateStruct":534,"leadSponsor":536,"locationsCount":299},"100559858","real-world-european-investigation-of-safety-and-clinical-efficacy-of-the-evoque-system-triscend-iii-eu-100559858","NCT06569602","Real World European Investigation of Safety and Clinical Efficacy of the EVOQUE System (TRISCEND III EU)","Edwards EVOQUE Transcatheter Tricuspid Valve Replacement: Real World European Investigation of Safety and Clinical Efficacy Using a Novel Device","Inclusion Criteria:\n\n1. The Local Site Heart Team determines that the patient is appropriate for transcatheter tricuspid valve replacement with the EVOQUE system per the current instructions for use.\n2. Patient agrees to attend follow-up assessments.\n3. Patients provided written informed consent for participation in the study.\n\nExclusion Criteria:\n\n1. Patient participating in another interventional biologic, drug, or device clinical study that has not met its primary endpoint(s).\n2. Any patient considered to be part of a vulnerable population.",{"count":19,"type":20},"This is a prospective, single-arm, multi-center, real-world study of an the Edwards EVOQUE system.",[118,26,87],"2024-10-29",{"date":531,"type":31},"2024-10-31",{"date":533,"type":31},"2024-10-01",{"date":535,"type":20},"2033-09-30",{"name":537,"class":72},"Edwards Lifesciences",{"id":539,"slug":540,"hasResults":12,"nctId":541,"briefTitle":542,"officialTitle":543,"acronym":544,"eligibilityCriteria":545,"healthyVolunteers":12,"sex":16,"minAge":260,"maxAge":546,"enrollmentInfo":547,"targetDuration":4,"studyType":84,"phases":4,"briefSummary":548,"conditions":549,"keywords":551,"overallStatus":119,"whyStopped":4,"lastUpdateSubmitDate":554,"lastUpdatePostDateStruct":555,"startDateStruct":557,"completionDateStruct":559,"leadSponsor":561,"locationsCount":39},"100560015","psoas-muscle-index-pmi-as-a-predictor-of-outcomes-after-minimally-invasive-cardiac-surgery-100560015","NCT06571643","Psoas Muscle Index (PMI) as a Predictor of Outcomes After Minimally Invasive Cardiac Surgery","Psoas Muscle Index (PMI) as a Predictor of Mobilisation and Postoperative Length of Stay After Minimally Invasive Cardiac Surgery","PsoMICS","Inclusion Criteria:\n\n* Elderly patients (≥ 65 years old)\n* Able to take consent\n* Listed for minimally invasive cardiac surgery\n* Elective and urgent procedures included\n* Able to undergo MRI\n\nExclusion Criteria:\n\n* Full median sternotomy approach\n* Emergency procedures\n* Unable to take consent\n* Unable to undergo MRI","99 Years",{"count":7,"type":20},"Sarcopenia or muscle loss and function is a component of the frailty syndrome. In this sense, frailty is becoming an important risk factor in predicting outcomes after major surgery and is defined as a geriatric syndrome of decreased reserve and resiliency to stressors that have been associated with adverse health outcomes in older adults. Despite its potentially relevant role in predicting postoperative recovery, frailty is rarely evaluated before surgery, and this is partially due to the low reliability of the most used frailty scores. Therefore, improvement in the frailty evaluation would be beneficial during the preoperative assessment of major surgeries. Sarcopenia, or the decline of skeletal muscle tissue with age, is one of the most important causes of functional decline and loss of independence in older adults and low muscle mass is a core component of frailty that has the advantage of being objectively quantifiable regardless of mobility, disability, or illness acuity. Psoas Muscle (PM) mass is an important parameter for evaluating muscle mass and has been previously correlated to frailty with a negative impact on the postoperative outcomes after major surgery and Psoas Muscle mass Index (PMI) is an easily available parameter for evaluating muscle mass and has already been demonstrated to be effective in predicting outcomes in different clinical settings. PMI has also been shown to be an effective predictor of outcomes in cardiac surgery although there are no studies specifically focusing on minimally invasive cardiac surgery. With this study, the investigators aim to investigate the relevance of PMI as a predictor of postoperative mobilisation, hospital length of stay and clinical recovery after major cardiac surgery conducted via a minimally invasive approach.",[550,26],"Sarcopenia",[552,553],"Minimally invasive cardiac surgery","Psoas Muscle Index","2024-08-23",{"date":556,"type":31},"2024-08-26",{"date":558,"type":20},"2024-09-01",{"date":560,"type":20},"2025-12-01",{"name":562,"class":38},"I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio",{"id":564,"slug":565,"hasResults":12,"nctId":566,"briefTitle":567,"officialTitle":568,"acronym":4,"eligibilityCriteria":569,"healthyVolunteers":12,"sex":16,"minAge":48,"maxAge":570,"enrollmentInfo":571,"targetDuration":4,"studyType":21,"phases":573,"briefSummary":574,"conditions":575,"keywords":577,"overallStatus":119,"whyStopped":4,"lastUpdateSubmitDate":580,"lastUpdatePostDateStruct":581,"startDateStruct":583,"completionDateStruct":585,"leadSponsor":587,"locationsCount":4},"100557697","multicentre-clinical-study-of-ultra-fast-track-anaesthesia-for-minimally-invasive-heart-valve-surgery-100557697","NCT06541483","Multicentre Clinical Study of Ultra-Fast-Track Anaesthesia for Minimally Invasive Heart Valve Surgery","A Multicenter Clinical Study of Ultra-Fast-Track Cardiac Anesthesia in Minimally Invasive Cardiac Surgery for Valvular Heart Disease","Inclusion Criteria:\n\n* Age ≥18 and ≤80 years\n* American Society of Anaesthesiologists (ASA) class I-III\n* New York Heart Association (NYHA) cardiac class III or below\n* Preoperative inspired air pulse oximetry (SpO2) ≥95%\n* Ejection fraction (EF) ≥ 40%\n* No contraindications to nerve blocks\n\nExclusion Criteria:\n\n* Patient's refusal to participate\n* Severe communication disorders\n* Severe disorders of coagulation with spontaneous bleeding tendency\n* Long-term application of opioid analgesics\n* Pulmonary hypertension (mean pulmonary artery pressure ≥55 mmHg)\n* People who need artificial ventilation\n* Allergy to dexmedetomidine and ropivacaine\n* Complex aortic root surgery such as root widening","80 Years",{"count":572,"type":20},1200,[23],"The goal of this clinical trial is to evaluate the clinical effects of ultra-fast-track anesthesia (UFTA) for minimally invasive cardiac surgery (MICS) in adults. It will also learn about the safety and feasibility of Ultra-Fast-Track cardiac surgery(UFTCA).The main questions it aims to answer are:Does UFTCA promote rapid postoperative recovery, reduce postoperative complications and perioperative mortality, and improve the quality of mid- and long-term survival.And does it improve patient satisfaction and reduce healthcare costs.\n\nParticipants will receive homogenized perioperative management in the cardiac ward, extracorporeal circulation, and postoperative ICU, except for anesthesia extubation time.Furthermore，Participants need complete quality of life scales at 30 days, 90 days, six months, and one year after surgery, separately.\n\nParticipants in this study are adults who required elective minimally invasive heart valve surgery under extracorporeal circulation.This study will be able to promote rapid recovery while reducing the associated costs and the financial burden on participants.Retrospective big data analysis of perioperative clinical characteristics of patients undergoing minimally invasive heart valve surgery to establish a risk warning model and develop a perioperative management program. The investigators then conducts a randomized group trial comparing the similarities and differences between conventional general anesthesia（CGA） and ultra-fast-track cardiac anesthesia(URTCA) to demonstrate the effectiveness and safety of UFTA in MICS.Finally, building expert consensus.",[26,576],"Enhanced Recovery After Surgery",[578,579],"Ultra-fast-track Anesthesia","minimally invasive cardiac surgery","2024-08-02",{"date":582,"type":31},"2024-08-07",{"date":584,"type":20},"2024-12",{"date":586,"type":20},"2028-12",{"name":588,"class":38},"Zhejiang Provincial People's Hospital",{"id":590,"slug":591,"hasResults":12,"nctId":592,"briefTitle":593,"officialTitle":594,"acronym":595,"eligibilityCriteria":596,"healthyVolunteers":12,"sex":16,"minAge":83,"maxAge":570,"enrollmentInfo":597,"targetDuration":4,"studyType":84,"phases":4,"briefSummary":599,"conditions":600,"keywords":610,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":615,"lastUpdatePostDateStruct":616,"startDateStruct":618,"completionDateStruct":620,"leadSponsor":621,"locationsCount":39},"100516173","prognosis-prediction-system-of-patients-with-cardiovascular-and-cerebrovascular-diseases-based-on-multi-omics-100516173","NCT06001073","Prognosis Prediction System of Patients With Cardiovascular and Cerebrovascular Diseases Based on Multi-omics","Prognosis Prediction System of Patients With Cardiovascular and Cerebrovascular Diseases Based on Multi-omics (PROSPECT): a National, Multicenter, Retrospective-prospective, Cohort Study","PROSPECT","Inclusion Criteria:\n\n* Patients who are regularly visited and followed up in the appropriate patient; department.\n* All patients met at least one of the following diagnostic criteria for cardiovascular and cerebrovascular diseases:\n* coronary artery disease group;\n* arrhythmia group;\n* heart valve disease group;\n* aortic dissection group;\n* cardiac masses group;\n* myocarditis group;\n* hypertension group;\n* cardiomyopathy group;\n* structural heart disease group;\n* ischemic cerebrovascular disease group;\n* hemorrhagic cerebrovascular disease group;\n* intracranial space occupying lesion group.\n\nExclusion Criteria:\n\n* Age \\\u003C3 years or \\>80 years old;\n* Pregnant and lactating women;\n* The patient declined to provide informed consent to participate in the study;\n* None of the above was met, but the patient was temporarily unable to sign the informed consent form due to coma and other reasons, and no legal representative signed it instead. Depending on the patient's condition, the patient may not be able to regain consciousness and sign the informed consent form.",{"count":598,"type":20},25000,"The etiology and specific pathogenesis of many cardiovascular diseases such as coronary atherosclerosis, cardiomyopathy, atrial fibrillation, and stroke are still unclear. Improving diagnosis and treatment, clarifying the pathogenesis, and providing scientific basis for the prevention and treatment are hot research topics in the study of cardiovascular and cerebrovascular diseases. This study intends to collect clinical data and biological specimen data of patients with cardiovascular and cerebrovascular diseases who meet the inclusion and exclusion criteria, and use multi-omics technology to deeply understand the pathogenic mechanisms of cardiovascular and cerebrovascular diseases and provide new ideas for specific and individualized treatment of patients with cardiovascular and cerebrovascular diseases, to construct early predictive prognostic models and provide a basis for effective treatment of clinical practice in patients with cardiovascular and cerebrovascular diseases.",[393,601,26,602,603,90,604,605,606,607,608,609],"Arrhythmias, Cardiac","Aortic Dissection","Heart Neoplasms","Hypertension","Cardiomyopathies","Structural Heart Disease","Ischemic Cerebrovascular Disease","Hemorrhagic Cerebrovascular Disease","Brain Neoplasms",[611,612,613,614],"Cardiovascular diseases","Cerebrovascular diseases","Prognosis","Multi-omics","2024-07-10",{"date":617,"type":31},"2024-07-12",{"date":619,"type":31},"2022-12-05",{"date":100,"type":20},{"name":622,"class":38},"First Affiliated Hospital Xi'an Jiaotong University",{"id":624,"slug":625,"hasResults":12,"nctId":626,"briefTitle":627,"officialTitle":627,"acronym":628,"eligibilityCriteria":629,"healthyVolunteers":12,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":630,"targetDuration":632,"studyType":84,"phases":4,"briefSummary":633,"conditions":634,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":635,"lastUpdatePostDateStruct":636,"startDateStruct":637,"completionDateStruct":639,"leadSponsor":641,"locationsCount":39},"100337541","the-prospective-leuven-transcatheter-valve-therapy-registry-100337541","NCT03674788","The Prospective LEUVEN Transcatheter Valve Therapy Registry","LEUVEN-TVT","Inclusion Criteria:\n\n* All patients selected for percutaneous treatment of a valve disorder potentially qualify for the present registry\n\nExclusion Criteria:\n\n* All patients selected for percutaneous treatment of a valve disorder potentially qualify for the present registry. There are no formal exclusion criteria.",{"count":631,"type":20},5000,"10 Years","Assessment of feasibility, safety and outcomes of transcatheter valve interventions",[26],"2024-07-02",{"date":167,"type":31},{"date":638,"type":31},"2008-03-12",{"date":640,"type":20},"2037-12-31",{"name":642,"class":38},"Universitaire Ziekenhuizen KU Leuven",{"id":644,"slug":645,"hasResults":12,"nctId":646,"briefTitle":647,"officialTitle":648,"acronym":4,"eligibilityCriteria":649,"healthyVolunteers":12,"sex":16,"minAge":48,"maxAge":500,"enrollmentInfo":650,"targetDuration":4,"studyType":21,"phases":652,"briefSummary":653,"conditions":654,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":655,"lastUpdatePostDateStruct":656,"startDateStruct":658,"completionDateStruct":660,"leadSponsor":662,"locationsCount":39},"100552009","phase-4-to-investigate-the-effect-of-esketamine-hydrochloride-on-pulmonary-complications-100552009","NCT06467513","To Investigate the Effect of Esketamine Hydrochloride on Pulmonary Complications","To Investigate the Effect of Esketamine on Hemodynamics and Postoperative Pulmonary Complications in Patients Undergoing Heart Valve Replacement Surgery","Inclusion Criteria:\n\n* Age 18-75 years old, gender unlimited.\n* Elective heart surgery.\n* Patients who plan to undergo mitral and (or) aortic valve replacement (or repair) surgery, requiring extracorporeal circulation and aortic occlusion.\n* The New York Heart Association class is less than 4.\n* Voluntarily sign informed consent.\n\nExclusion Criteria:\n\n* Non-cardiac surgery.\n* Second heart surgery.\n* Interventional surgery in heart valve surgery (TAVI, mitral clamp).\n* The patient refuses.\n* Pregnant women.\n* Patients with a history of lung surgery.\n* Patients with acute kidney injury requiring dialysis.\n* Patients with chronic renal insufficiency (stage III and above).\n* The patient was intubated before arriving at the operating room.\n* Patients with existing pulmonary complications (respiratory tract infection, pneumonia, pleural effusion, respiratory failure, atelectasis, pneumothorax, bronchospasm, ARDS).\n* The patient had neuropsychiatric disease and cognitive impairment before surgery.\n* Drug users and other long-term use of antipsychotic drugs.\n* Patients with any of the following contraindications for the use of ESketamine injection: patients with serious risk of elevated blood pressure or intracranial pressure; Patients with high intraocular pressure (glaucoma) or penetrating ocular trauma; Patients with poorly controlled or untreated hypertension (arterial hypertension, resting systolic pressure exceeding 180 mmHg, or resting diastolic pressure exceeding 100mmHg); Patients with untreated or undertreated hyperthyroidism (hyperthyroidism).\n* Liver function ALT, AST \\> 2 times normal.",{"count":651,"type":20},102,[363],"The objective of this study was to evaluate the effect of esketamine on intraoperative hemodynamics in patients with heart valve replacement and to mitigate postoperative pulmonary complications",[207,26],"2024-06-14",{"date":657,"type":31},"2024-06-21",{"date":659,"type":31},"2024-01-01",{"date":661,"type":20},"2025-05",{"name":663,"class":38},"Zhang XIao Mei"]