[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"mitral-stenosis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:mitral-stenosis":25},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,10,0,[8,47,71,100,126,152,172,197,232,263],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":20,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":31,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100598298","abbott-cephea-mitral-valve-disease-registry-100598298",false,"NCT07069673","Abbott Cephea Mitral Valve Disease Registry","Inclusion Criteria:\n\n1. Symptomatic mitral valve disease resulting in mitral regurgitation and\u002For severe mitral valve stenosis.\n2. New York Heart Association (NYHA) Functional Class II, III, or ambulatory IV.\n3. In the judgement of the Site Heart Team, transcatheter therapy is deemed to be more appropriate than conventional mitral valve surgery, TMVR is more likely to provide an optimal result than TEER, and the subject has been adequately treated per applicable standards, including for coronary artery disease, left ventricular dysfunction, and heart failure.\n4. Age 18 years or older at time of consent.\n5. The subject agrees to the study requirements, permits all follow-up data entry, and has provided written informed consent.\n\nExclusion Criteria:\n\n1. Prior surgical or interventional treatment that interferes with the Cephea valve delivery or function.\n2. Subject is undergoing dialysis or experiencing chronic renal failure\n3. Subject has chronic lung disease requiring continuous home oxygen therapy or chronic outpatient oral steroid use\n4. Subjects with comorbidities that are likely to result in a life expectancy of less than 12 months.\n5. Pregnant or nursing subjects and those who plan pregnancy during the follow-up period.","ALL","18 Years",{"count":18,"type":19},1000,"ESTIMATED","2 Years","OBSERVATIONAL","The objective of this registry is to gather clinical data on symptomatic patients with mitral valve disease, including patients with mitral regurgitation, mitral stenosis, and mixed mitral valve disease. Data collected from this registry are expected to improve our understanding of the impact of correcting symptomatic mitral valve disease on clinical outcomes in patients that could be candidates for Transcatheter Mitral Valve Replacement and may also inform future regulatory or reimbursement submission strategies for the Cephea Mitral Valve System.",[24,25,26,27,28,29,30],"Mitral Regurgitation","Mitral Stenosis","Mitral Valve Disease","Mitral Valve (MV) Regurgitation","Mitral Annulus Calcification","Mitral Valve Replacement","Transcatheter Valve Replacement",[26,32,33],"registry","Cephea Mitral Valve System","RECRUITING","2026-06-18",{"date":37,"type":38},"2026-06-22","ACTUAL",{"date":40,"type":38},"2025-08-13",{"date":42,"type":19},"2028-12",{"name":44,"class":45},"Abbott Medical Devices","INDUSTRY",23,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":55,"phases":56,"briefSummary":58,"conditions":59,"keywords":60,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":70},"100611773","cephea-south-america-feasibility-study-100611773","NCT07244939","Cephea South America Feasibility Study","Key Inclusion Criteria:\n\n* Mitral valve disease resulting in mitral regurgitation (MR ≥ Grade III) and\u002For severe mitral valve stenosis (mitral valve area ≤ 1.5cm²) per American Society of Echocardiography criteria\n* LVEF ≥ 30%\n* In the judgement of the Site Heart Team, transcatheter therapy is deemed more appropriate than open heart surgery\n\nKey Exclusion Criteria:\n\n* Prior surgical or interventional treatment that interferes with the Cephea valve delivery or function\n* Need for emergent or urgent surgery",{"count":54,"type":19},20,"INTERVENTIONAL",[57],"NA","The objective of this study is to evaluate the preliminary safety and effectiveness of the Cephea Mitral Valve System for the treatment of symptomatic patients with mitral valve disease (including mitral regurgitation, mitral stenosis and mixed mitral valve disease) in whom transcatheter therapy is deemed more appropriate than open heart surgery.",[24,25],[61,33],"Symptomatic mitral valve disease","2026-02-05",{"date":64,"type":38},"2026-02-06",{"date":66,"type":38},"2025-06-17",{"date":68,"type":19},"2028-09",{"name":44,"class":45},3,{"id":72,"slug":73,"hasResults":11,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":4,"eligibilityCriteria":77,"healthyVolunteers":78,"sex":15,"minAge":16,"maxAge":79,"enrollmentInfo":80,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":82,"conditions":83,"keywords":84,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":99},"100623312","assessment-of-exercise-capacity-muscle-oxygenation-and-aortic-stiffness-in-patients-with-mitral-stenosis-100623312","NCT07394998","Assessment of Exercise Capacity, Muscle Oxygenation and Aortic Stiffness in Patients With Mitral Stenosis","Comparison of Exercise Capacity, Muscle Oxygenation and Aortic Stiffness in Patients With a History of Mitral Valve Intervention for Mitral Stenosis With Healthy Subjects","Inclusion Criteria:\n\nPatients;\n\n* Between the ages of 18-80\n* Patients who have undergone mitral valve intervention due to mitral stenosis\n* At least 3 months have passed since the intervention\n\nHealthy controls;\n\n* Between the ages of 18 and 80\n* Agreeing to participate voluntarily in the study\n\nExclusion Criteria:\n\nPatients;\n\n* Patients who have undergone aortic valve intervention other than mitral valve intervention\n* Acute infection\n* Orthopedic, neurological or psychological disorders that will affect functional capacity\n\nHealthy Controls;\n\n* diagnosed chronic disease,\n* acute infection\n* A smoking history of at least 10 packs×years or more",true,"80 Years",{"count":81,"type":19},40,"Heart valve diseases are the most common cause of mortality and morbidity after coronary artery disease, hypertension, and heart failure. In patients with mitral stenosis, the narrowed valve restricts blood flow, causing symptoms such as shortness of breath, fatigue, exertional dyspnea, orthopnea, and paroxysmal nocturnal dyspnea. These patients may experience decreased exercise capacity and physical activity levels, deterioration in quality of life, and deterioration in respiratory function. When reviewing the literature, we see that the study groups evaluating these factors are generally not homogeneous, and most studies conducted in patients with mitral stenosis evaluate patients who have undergone percutaneous mitral balloon valvuloplasty.",[25],[85,86,87,88,89],"cardiopulmonary exercise test","aortic stiffness","muscle oxygenation","physical activity","mitral stenosis","2026-01-31",{"date":64,"type":38},{"date":93,"type":38},"2025-01-13",{"date":95,"type":19},"2026-07",{"name":97,"class":98},"Gazi University","OTHER",1,{"id":101,"slug":102,"hasResults":11,"nctId":103,"briefTitle":104,"officialTitle":105,"acronym":106,"eligibilityCriteria":107,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":108,"targetDuration":4,"studyType":55,"phases":110,"briefSummary":111,"conditions":112,"keywords":114,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":116,"lastUpdatePostDateStruct":117,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":125},"100393852","the-mitral-ii-pivotal-trial-mitral-implantation-of-transcatheter-valves-100393852","NCT04408430","The MITRAL II Pivotal Trial (Mitral Implantation of TRAnscatheter vaLves).","The Safety and Effectiveness of the Edwards SAPIEN 3, SAPIEN 3 Ultra, and SAPIEN 3 Ultra RESILIA (SAPIEN 3\u002FUltra\u002FRESILIA) Valve in Patients With Symptomatic Severe Calcific Mitral Valve Disease With Severe Mitral Annular Calcification Who Are Not Candidates for Standard Mitral Valve Surgery.","MITRAL-II","Inclusion Criteria:\n\nAll Candidates must meet the following criteria:\n\n1. \\- 18 years of age or older\n2. -Severe mitral annular calcification with symptomatic mitral valve dysfunction including severe mitral stenosis defined as mitral valve area (MVA) of ≤1.5 cm2, or ≥ moderate to severe mitral regurgitation, or mixed ≥ moderated stenosis and ≥ moderate regurgitation. For this study, the severity of mitral regurgitation will be graded according to the 2017 American Society of Echocardiography Guidelines: None, Trivial, Mild 1(+), Moderate 2(+), Moderate to severe 3(+), and severe 4(+).\n3. \\- NYHA Functional Class ≥II.\n4. The heart team agrees that valve implantation will likely benefit the patient.\n5. High or prohibitive risk for standard mitral valve surgery as determined by the heart team (at least one site cardiac surgeon must personally examine the subject to determine operative risk in patients presented for inclusion to ViMAC arm). NOTE: Patients not interested in mitral intervention or who are being considered for inclusion in the Natural History of Disease Registry are not required to be evaluated in person by a surgeon.)\n6. The study patient has been informed of the nature of the study, agrees to its provisions and has provided written informed consent as approved by the Institutional Review Board (IRB) of the respective clinical site.\n7. The study patient agrees to comply with all required post-procedure follow-up visits including annual visits through 5 years.\n\nExclusion Criteria for ViMAC subjects (does not apply to the Natural History of Disease Registry):\n\n1. \\- The heart team considers the patient is a surgical candidate.\n2. \\- Mitral annulus is not severely calcified.\n3. \\- Myocardial infarction requiring revascularization within 30 days from procedure.\n4. \\- Clinically significant untreated coronary artery disease requiring revascularization.\n5. Any therapeutic invasive cardiac procedure resulting in a permanent implant that is performed within 30 days of the index procedure (unless part of planned strategy for treatment of concomitant coronary artery disease). Implantation of a permanent pacemaker is not exclusionary.\n6. Any patient with a balloon valvuloplasty (BMV) within 30 days of the procedure (unless BMV is a bridge to ViMAC procedure after a qualifying Echo).\n7. Severe symptomatic tricuspid regurgitation (hepatic dysfunction, ascites, edema not controlled with diuretics) requiring surgery.\n8. Leukopenia (WBC \\\u003C 3000 cell\u002FmL), acute anemia (Hgb \\\u003C 9 g\u002FdL), Thrombocytopenia (Platelets \\\u003C 50,000 cell\u002FmL), history of coagulopathy or hypercoagulable state.\n9. Hypertrophic obstructive cardiomyopathy (HOCM) with mean LVOT gradient of ≥20 mm Hg at rest or ≥50 mmHg with Valsalva.\n10. Hemodynamic or respiratory instability requiring inotropic support, mechanical ventilation or mechanical heart assistance within 30 days of screening evaluation.\n11. Need for emergency surgery for any reason.\n12. Severe left ventricular dysfunction with LVEF \\\u003C 20%.\n13. Echocardiographic evidence of intracardiac mass, thrombus or vegetation.\n14. Active upper GI bleeding within 90 days prior to procedure.\n15. A known contraindication or hypersensitivity to all anticoagulation regimens, or inability to be anticoagulated for the study procedure.\n16. Cardiac anatomy that would preclude appropriate delivery and deployment of an Edwards SAPIEN 3\u002FUltra\u002FRESILIA valve in MAC via transseptal access, including but not limited to:\n\n    * Native neo mitral annulus size \\\u003C 275 mm2 or \\> 810 mm2 as measured by CT scan.\n    * Significant risk of LVOT obstruction or valve embolization as assessed by CT core lab\n17. Clinically (by neurologist) or neuroimaging confirmed stroke or transient ischemic attack (TIA) within 90 days of the procedure.\n18. Estimated life expectancy \\\u003C12 months due to non-cardiac conditions.\n19. Expectation that patient will not improve despite treatment of mitral valve dysfunction.\n20. Active bacterial endocarditis within 180 days of procedure.\n21. \\- Severe right ventricular dysfunction as assessed by Echo core lab\n22. \\- Active infection requiring antibiotic therapy (subject may be a candidate after 2 weeks of antibiotic discontinuation.\n23. \\- Female who is pregnant or lactating.\n24. \\- Participating in another investigational device study.\n25. \\- Aortic valve disease requiring intervention. If aortic valve intervention is required, the AVR procedure should be performed first and if the patient remains symptomatic after AVR, may be presented for consideration for inclusion in this trial.\n26. \\- Severe fixed pulmonary hypertension (PASP ≥70 mmHg and more than 2\u002F3 of the systemic systolic blood pressure).\n27. \\- Severe chronic obstructive pulmonary disease requiring continuous home oxygen.\n28. \\- The patient refuses mitral valve intervention\n29. \\- Recent symptomatic COVID-19 infection with residual symptoms that may affect the outcomes of this trial.",{"count":109,"type":19},210,[57],"A prospective multicenter study enrolling high surgical risk patients with severe mitral annular calcification (MAC) and symptomatic mitral valve dysfunction (severe stenosis, ≥ moderate to severe regurgitation, or mixed ≥ moderate stenosis and ≥ regurgitation). There are 2 Arms in this study: 1) \"Transseptal (TS) Valve-in-MAC\" (ViMAC) Arm, and 2) Natural History of Disease Registry (NHDR) for patients treated with medical treatment only (which includes patients who meet inclusion criteria but can't be treated with transeptal ViMAC due to the presence of anatomical exclusion criteria or other exclusion criteria) and have not had other procedures that may impact outcomes (i.e., alcohol septal ablation or radiofrequency ablation). The study also includes a Registry of Permanently Unassigned\" for subjects who undergo preemptive septal ablation procedures (alcohol or radiofrequency) in anticipation of continuing onto ViMAC arm, but are not accepted in the ViMAC Study arm or the patient chooses not to undergo ViMAC procedure.",[113,25,24,26],"Mitral Annular Calcification",[115],"Transcatheter Mitral Valve Replacement","2026-01-12",{"date":118,"type":38},"2026-01-13",{"date":120,"type":38},"2021-03-08",{"date":122,"type":19},"2030-12",{"name":124,"class":98},"Mayra Guerrero",17,{"id":127,"slug":128,"hasResults":11,"nctId":129,"briefTitle":130,"officialTitle":131,"acronym":4,"eligibilityCriteria":132,"healthyVolunteers":11,"sex":15,"minAge":4,"maxAge":4,"enrollmentInfo":133,"targetDuration":4,"studyType":55,"phases":135,"briefSummary":136,"conditions":137,"keywords":138,"overallStatus":142,"whyStopped":4,"lastUpdateSubmitDate":143,"lastUpdatePostDateStruct":144,"startDateStruct":146,"completionDateStruct":148,"leadSponsor":150,"locationsCount":4},"100528933","alliance-mitral-safety-and-effectiveness-of-sapien-x4-transcatheter-heart-valve---mitral-100528933","NCT06167213","ALLIANCE Mitral: Safety and Effectiveness of SAPIEN X4 Transcatheter Heart Valve - Mitral","Safety and Effectiveness of Balloon-Expandable Bioprosthetic SAPIEN X4 Transcatheter Heart Valve - Mitral","Inclusion Criteria:\n\n1. Failing mitral surgical bioprosthetic valve or a failing native mitral valve with an annuloplasty ring demonstrating ≥ moderate stenosis and\u002For ≥ moderate insufficiency\n2. Bioprosthetic surgical valve or native mitral annulus size suitable for SAPIEN X4 THV\n3. NYHA functional class ≥ II\n4. Heart Team agrees the subject is at high or greater surgical risk\n5. The subject has been informed of the nature of the study, agrees to its provisions, and has provided written informed consent.\n\nExclusion Criteria:\n\n1. Anatomical characteristics that would preclude safe femoral placement of the introducer sheath or safe passage of the delivery system\n2. Interatrial septum or left atrium not suitable for transcatheter transseptal access\n3. Failing valve has mild or greater paravalvular regurgitation\n4. Failing valve is unstable, rocking, or not structurally intact\n5. Annuloplasty ring dehiscence\n6. Known severe patient-prosthesis mismatch or bioprosthetic valve with residual mean gradient \\> 10 mmHg at the end of the index procedure for implantation of the original valve\n7. Annuloplasty ring type not favorable for THV implantation\n8. Increased risk of THV embolization\n9. Anatomical characteristics that would increase risk of left ventricular outflow tract (LVOT) obstruction\n10. Surgical or transcatheter aortic valve extending into LVOT that may impinge on the mitral implant\n11. Severe right ventricle (RV) dysfunction\n12. Severe regurgitation or stenosis of any other valve\n13. Need for aortic, tricuspid, or pulmonic valve intervention within the next 12 months\n14. Left ventricular ejection fraction \\\u003C 20%\n15. Cardiac imaging evidence of intracardiac mass, thrombus, or vegetation\n16. Myocardial infarction within 30 days prior to the study procedure\n17. Hypertrophic cardiomyopathy with subvalvular obstruction\n18. Subjects with planned concomitant ablation for atrial fibrillation\n19. Clinically significant coronary artery disease requiring revascularization\n20. Any surgical or transcatheter procedure within 30 days prior to the study procedure. Implantation of a permanent pacemaker or implantable cardioverter defibrillator (ICD) is not considered an exclusion.\n21. Any planned surgical or transcatheter intervention to be performed within 30 days following the study procedure\n22. Endocarditis within 180 days prior to the study procedure\n23. Stroke, transient ischemic attack or neurological signs and symptoms attributed to carotid or vertebrobasilar disease within 90 days prior to the study procedure\n24. Hemodynamic or respiratory instability requiring inotropic or mechanical support within 30 days prior to the study procedure\n25. Renal insufficiency and\u002For renal replacement therapy\n26. Leukopenia, anemia, thrombocytopenia\n27. Inability to tolerate or condition precluding treatment with antithrombotic therapy\n28. Hypercoagulable state or other condition that increases risk of thrombosis\n29. Absolute contraindications or allergy to iodinated contrast that cannot be adequately treated with premedication\n30. Subject refuses blood products\n31. Body mass index \\> 50 kg\u002Fm2\n32. Estimated life expectancy \\\u003C 24 months\n33. Female who is pregnant or lactating\n34. Active SARS-CoV-2 infection or previously diagnosed with COVID-19 with sequelae that could confound endpoint assessments\n35. Participating in another investigational drug or device study that has not reached its primary endpoint\n36. Subject considered to be part of a vulnerable population",{"count":134,"type":19},125,[57],"This study will establish the safety and effectiveness of the Edwards SAPIEN X4 Transcatheter Heart Valve (THV) in subjects who are at high or greater surgical risk with a failing mitral surgical bioprosthetic valve or a failing native mitral valve with an annuloplasty ring.",[24,26,25],[139,140,141],"SAPIEN X4","Valve-in-Valve","Valve-in-Ring","NOT_YET_RECRUITING","2025-12-18",{"date":145,"type":38},"2025-12-22",{"date":147,"type":19},"2027-01",{"date":149,"type":19},"2038-03",{"name":151,"class":45},"Edwards Lifesciences",{"id":153,"slug":154,"hasResults":11,"nctId":155,"briefTitle":156,"officialTitle":156,"acronym":4,"eligibilityCriteria":157,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":158,"enrollmentInfo":159,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":161,"conditions":162,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":163,"lastUpdatePostDateStruct":164,"startDateStruct":166,"completionDateStruct":168,"leadSponsor":170,"locationsCount":99},"100606436","prospective-multicenter-registry-of-patients-with-mitral-stenosis-undergoing-percutaneous-mitral-balloon-commissurotomy-100606436","NCT07175532","Prospective Multicenter Registry of Patients With Mitral Stenosis Undergoing Percutaneous Mitral Balloon Commissurotomy","Inclusion Criteria:\n\n* Patients with mitral stenosis undergoing PMBC\n\nExclusion Criteria:\n\n* Patients who cannot understand this study due to mental illness\n* Serious comorbidity limiting life expectancy within 1 year\n* Limited activity (NYHA class III or IV) due to non-cardiac disease","89 Years",{"count":160,"type":19},400,"The goal of this observational study is to learn about the clinical outcomes after percutaneous mitral balloon commissurotomy (PMBC) for patients with mitral stenosis (MS) using nation-wide multicenter prospective registry including tertiary-referral hospitals in Korea.\n\nThe main question it aims to answer is:\n\nWhat is the clinical outcomes after PMBC? Which method is appropriate to determine inflated Inoue balloon size?",[25],"2025-09-15",{"date":165,"type":38},"2025-09-16",{"date":167,"type":38},"2025-05-01",{"date":169,"type":19},"2031-12-31",{"name":171,"class":98},"Asan Medical Center",{"id":173,"slug":174,"hasResults":11,"nctId":175,"briefTitle":176,"officialTitle":177,"acronym":178,"eligibilityCriteria":179,"healthyVolunteers":11,"sex":15,"minAge":180,"maxAge":4,"enrollmentInfo":181,"targetDuration":4,"studyType":55,"phases":182,"briefSummary":183,"conditions":184,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":188,"lastUpdatePostDateStruct":189,"startDateStruct":191,"completionDateStruct":193,"leadSponsor":195,"locationsCount":99},"100600457","early-feasibility-study-of-surgical-implantation-of-a-polymer-prosthetic-mitral-and-aortic-valve-100600457","NCT07097740","Early Feasibility Study of Surgical Implantation of a Polymer Prosthetic Mitral and Aortic Valve","A Prospective Early Feasibility Clinical Study of Surgical Implantation of a Polymer Prosthetic Heart Valve","POLYVALVE-FIH","Inclusion Criteria:\n\n* Adults requiring surgical replacement of either mitral or aortic valve\n* Capable of undergoing cardiopulmonary bypass\n* Able to tolerate anticoagulation therapy\n* Able to understand study purpose, willing to provide informed consent and comply with follow-up\n\nExclusion Criteria:\n\n1. History of previous cardiac valve surgery or percutaneous valve replacement, including surgical aortic or mitral valve replacement (excluding Percutaneous Balloon Mitral Valvuloplasty \\[PBMV\\], which is permitted).\n2. Requirement for urgent or emergency cardiac surgery.\n3. Planned concurrent aortic valve surgery or combined valve procedure (e.g., simultaneous aortic and mitral valve surgery).\n4. Scheduled coronary artery bypass graft (CABG) during the same admission.\n5. Anticipated need for additional non-valve cardiac surgery within 12 months.\n6. Active systemic infection, including pneumonia or infective endocarditis.\n7. Intracardiac thrombus detected on echocardiography or imaging.\n8. Stroke or transient ischemic attack within the prior 3 months.\n9. Myocardial infarction, unstable coronary syndrome, or coronary revascularization within the prior 3 months.\n10. Severe comorbidities with expected life expectancy \\\u003C12 months, including Child-Pugh C liver disease, end-stage malignancy, or advanced pulmonary disease.\n11. Participation in another interventional clinical trial involving investigational devices or drugs.\n12. Anatomical risk factors such as ascending aortic aneurysm (≥50 mm), bicuspid aortic valve with ascending aorta ≥45 mm, or other high-risk features identified on imaging.\n13. Left ventricular ejection fraction (LVEF) ≤35%, indicating severe systolic dysfunction.\n14. Severe renal insufficiency, e.g., estimated GFR \\\u003C30 mL\u002Fmin\u002F1.73 m² or requirement for chronic dialysis.\n15. Coagulopathy or active bleeding disorders, e.g., INR \\>1.5 without anticoagulation therapy.\n16. Hematologic abnormalities: hematocrit \\\u003C30%, hemoglobin \\\u003C100 g\u002FL, platelet count \\\u003C100 × 10⁹\u002FL, or WBC \\\u003C4 × 10⁹\u002FL or \\>10 × 10⁹\u002FL.\n17. History of substance abuse, chronic alcoholism, or significant psychiatric illness impairing study compliance.\n18. Preoperative or intraoperative anatomical unsuitability of the valve apparatus or cardiac structure.\n19. Known allergy or hypersensitivity to polyurethane, polyester, or sulfonate-based biomaterials used in the valve prosthesis.\n20. Withdrawal from the study after valve implantation (such participants are not allowed to re-enroll).","50 Years",{"count":5,"type":19},[57],"The goal of this clinical trial is to explore the early feasibility, initial safety, and efficacy of surgical implantation of a polymer prosthetic heart valve in patients requiring either mitral valve replacement or aortic valve replacement.\n\nThe main question it aims to answer is:\n\n\\-- What is the rate of valve-related complications, including thromboembolism, valve thrombosis, severe perivalvular leak, severe bleeding, and endocarditis, at 12 months post-operation?\n\nParticipants will undergo:\n\n* Surgical implantation of a polymer prosthetic valve (mitral valve replacement for mitral valve group and aortic valve replacement for aortic valve group).\n* Regular follow-up visits at 30 days, 3-6 months, and 12 months post-operation to evaluate clinical outcomes, including echocardiographic assessment and clinical event monitoring.",[185,26,186,187,25,24],"AORTIC VALVE DISEASES","Aortic Stenosis","Aortic Regurgitation","2025-07-24",{"date":190,"type":38},"2025-07-31",{"date":192,"type":38},"2025-06-27",{"date":194,"type":19},"2027-06",{"name":196,"class":45},"Mitrassist Lifesciences Limited Co., Ltd.",{"id":198,"slug":199,"hasResults":11,"nctId":200,"briefTitle":201,"officialTitle":202,"acronym":4,"eligibilityCriteria":203,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":204,"targetDuration":4,"studyType":55,"phases":206,"briefSummary":207,"conditions":208,"keywords":216,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":223,"lastUpdatePostDateStruct":224,"startDateStruct":226,"completionDateStruct":228,"leadSponsor":230,"locationsCount":99},"100545096","influence-of-lung-ultrasonography-on-the-prognosis-and-postoperative-outcomes-in-cardiac-surgical-patients-100545096","NCT06377449","Influence of Lung Ultrasonography on the Prognosis and Postoperative Outcomes in Cardiac Surgical Patients","Influence of Ultrasound Examination of the Lungs on the Prognosis and Postoperative Outcomes in Cardiac Surgical Patients","Inclusion Criteria:\n\n* open heart surgery with cardiopulmonary bypass (CPB) between 15 December 2023 and 15 December 2024\n* signed informed consent for participation in the study\n\nExclusion Criteria:\n\n* reoperations on the open heart with CPB\n* surgical procedures on lungs and lung cancer in the anamnesis\n* chronic obstructive pulmonary disease, stage III\n* chronic kidney disease, stages 4 and 5\n* patients with low Risk Score profile by the Society of Thoracic Surgeons",{"count":205,"type":19},186,[57],"The goal of this interventional is to assess advantages of the ultrasound examination of the lungs in the early postoperative period in cardiac surgical patients after heart surgeries requiring cardiopulmonary bypass. Evaluation of pulmonary complications and outcomes during mid-term follow-up, as well as comparison of ultrasound examination and traditional roentgenologic methods (X-ray examination and CT of the chest) will be performed. The main question\\[s\\] it aims to answer are:\n\n* Is ultrasound examination of the lungs a more specific and sensitive method in identification of early postoperative pulmonary complications after on-pump cardiac surgical procedures, in comparison with traditional X-ray methods.\n* Does early identification of interstitial pulmonary edema (based on number of visualised B-lines in the early postoperative period), influences mid-term outcomes in this cohort of patients Participants will undergo ultrasound examination of the lungs on postoperative day 1, 3, 5 and 7 after heart surgery. Based on ultrasound findings and degree of interstitial pulmonary edema, medical (diuretics, anti-inflammatory, e.t.c) therapy will be modified.\n\nResearchers will compare this group of patients with control group, in which ultrasound examination will be performed in the same time frames, but no changes in medical management based on ultrasound findings will be made to see if timely administered medical therapy, based on ultrasound findings, can significantly improve symptoms, hospital lengths of stay and outcomes of this patients.",[209,210,211,25,212,213,214,215],"Ischemic Heart Disease","Aortic Stenosis, Severe","Aortic Insufficiency","Mitral Insufficiency","Mitral Stenosis With Insufficiency","Tricuspid Insufficiency","Ascending Aortic Aneurysm",[217,218,219,220,221,222],"Ultrasound examination of the lungs","B-lines","Coronary artery bypass grafting","Heart valve surgery","Cardiopulmonary bypass","On-pump cardiac surgery","2024-12-04",{"date":225,"type":38},"2024-12-09",{"date":227,"type":38},"2024-05-15",{"date":229,"type":19},"2026-01-01",{"name":231,"class":98},"Saint Petersburg State University, Russia",{"id":233,"slug":234,"hasResults":11,"nctId":235,"briefTitle":236,"officialTitle":237,"acronym":4,"eligibilityCriteria":238,"healthyVolunteers":11,"sex":15,"minAge":239,"maxAge":240,"enrollmentInfo":241,"targetDuration":4,"studyType":55,"phases":243,"briefSummary":244,"conditions":245,"keywords":247,"overallStatus":142,"whyStopped":4,"lastUpdateSubmitDate":253,"lastUpdatePostDateStruct":254,"startDateStruct":256,"completionDateStruct":258,"leadSponsor":260,"locationsCount":262},"100567141","mild-anh-on-pre-bypass-coagulation-function-during-cardiac-surgery-100567141","NCT06664320","Mild ANH on Pre-bypass Coagulation Function During Cardiac Surgery","Impact of Mild Acute Normovolemic Hemodilution on Pre-bypass Coagulation Function During Cardiac Surgery","Inclusion Criteria:\n\n* patients undergoing cardiac surgery with cardiopulmonary bypass who signed written informed consent\n\nExclusion Criteria:\n\n* preoperative renal failure requiring reran replacement therapy\n* preoperative liver disease\n* preoperative low cardiac output (EF \\\u003C 50%)\n* Preoperative IABP application, Atrial fibrillation, Pacemaker\n* contraindication for applying TEE\n* intraoperative withdrawal","19 Years","65 Years",{"count":242,"type":19},70,[57],"The impact of acute normovolemic hemodilution (ANH) using hydroxyethyl starch before initiating cardiopulmonary bypass (CPB) on whole blood viscoelastic profile after CPB has not been well established. Patients undergoing cardiac surgery employing moderate hypothermic CPB are randomly allocated into one of two groups: in Group-ANH, ANH is applied by using a balanced hydroxyethyl starch (HES 130\u002F0.6); and in Group-C, ANH is not applied. After weaning from CPB, intergroup differences of INTEM, EXTEM, FIBTEM, and APTEM profiles are analyzed. As a primary outcome, the inter-group differences between maximal clot firmness of EXTEM will be determined at 10 min after ANH in Group-ANH and that at control.",[24,25,246],"Tricuspid Regurgitation",[248,249,250,251,252],"rotational thromboelastometry","cardiac surgery","acute normovolemic hemodilution","hemodilution","coagulation","2024-10-30",{"date":255,"type":38},"2024-10-31",{"date":257,"type":19},"2024-10-28",{"date":259,"type":19},"2025-04-30",{"name":261,"class":98},"Konkuk University Medical Center",2,{"id":264,"slug":265,"hasResults":11,"nctId":266,"briefTitle":267,"officialTitle":267,"acronym":4,"eligibilityCriteria":268,"healthyVolunteers":11,"sex":15,"minAge":4,"maxAge":4,"enrollmentInfo":269,"targetDuration":4,"studyType":55,"phases":271,"briefSummary":272,"conditions":273,"keywords":4,"overallStatus":142,"whyStopped":4,"lastUpdateSubmitDate":274,"lastUpdatePostDateStruct":275,"startDateStruct":277,"completionDateStruct":279,"leadSponsor":281,"locationsCount":4},"100542294","impact-of-percutaneous-transvenous-mitral-commissurotomy-on-the-left-atrial-appendage-function-in-patients-with-mitral-stenosis-100542294","NCT06340997","Impact of Percutaneous Transvenous Mitral Commissurotomy on The Left Atrial Appendage Function in Patients With Mitral Stenosis.","Inclusion Criteria:\n\n* • Patient eligible for PTMC as anatomical characteristics àpatient with sever MS (area 1.5cm2, echocardiographic score (Wilkins score ≤ 8, Cormier score 1 and 2 …), contraindication or high risk to surgical MVR.\n\nExclusion Criteria:\n\n* Patient with mitral regurgitation more than grade II .\n* Patient not eligible to PTMC.\n* Patient with severe heart failure (NHYA class IV) .\n* Patient with previous Cerebrovascular accident .\n* Patient with contraindication to TEE ( esophageal disease like stricture , diverticuli, varices, …, uncooperative patient )",{"count":270,"type":19},25,[57],"• Evaluation of the effect of PTMC on LAA function by TEE at least one month after the procedure and its effectiveness in prevention of thrombi formation and cerebrovascular complications.",[25],"2024-03-25",{"date":276,"type":38},"2024-04-02",{"date":278,"type":19},"2024-07-01",{"date":280,"type":19},"2027-08-01",{"name":282,"class":98},"Assiut University"]