[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Shanghai NewMed Medical Co., Ltd.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":130},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,40,68,90,110],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"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},"100377550","mi-thos-transcatheter-mitral-valve-replacement-study-100377550",false,"NCT04195984","Mi-thos® Transcatheter Mitral Valve Replacement Study","Evaluation of the Efficacy and Safety of the Mi-thos® Transcatheter Mitral Valve Replacement System in Patients with Severe Mitral Valve Disease At High Surgical Risk.","Inclusion Criteria:\n\n* Severe mitral valve regurgitation ≥ 3+;\n* High surgical risk fot open mitral valve surgery;\n* Age ≥ 65 years old;\n* Life expectancy \\> 12 months;\n* As assessed by multidisciplinary cardiac team, patients who are not eligible for surgery;\n* Patients sign an informed consent form.\n\nExclusion Criteria:\n\n* Previous cardiac mitral valve surgery;\n* Active infections requiring antibiotic therapy;\n* Clinically significant untreated Coronary Artery Disease (CAD);\n* Pulmonary hypertension （Pulmonary systolic pressure \\> 70 mmHg）;\n* Patients with severe right heart failure;\n* Left ventricular ejection fraction \\\u003C25%;\n* Diagnosis of hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis;\n* Dialysis patient;\n* Patients with severe coagulopathy;\n* Patients with contraindications to anticoagulant drugs;\n* Patients with stroke or transient ischemic within 30 days;\n* Echocardiography found any intracardiac mass, left ventricle or atrial thrombus;\n* Patients who require surgery or interventional therapy for other valvular lesions;\n* Patients with severe macrovascular disease requiring surgical treatment;\n* Patients with more than 70% of carotid stenosis;\n* To be allergic to contrast agents, nickel-titanium memory alloys or bovine-derived products;\n* Patients with severe neurological disorders affecting cognitive ability;\n* Patients with severe thoracic deformities.","ALL","65 Years",{"count":19,"type":20},122,"ESTIMATED","INTERVENTIONAL",[23],"NA","To evaluate the safety and performance of the Mi-thos® Mitral Heart Valve with the Mi-thos® Transcatheter Delivery System.",[26],"Mitral Valve Regurgitation","RECRUITING","2025-02-11",{"date":30,"type":31},"2025-02-13","ACTUAL",{"date":33,"type":31},"2021-03-25",{"date":35,"type":20},"2027-01",{"name":37,"class":38},"Shanghai NewMed Medical Co., Ltd.","INDUSTRY",3,{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":16,"minAge":47,"maxAge":48,"enrollmentInfo":49,"targetDuration":4,"studyType":21,"phases":51,"briefSummary":52,"conditions":53,"keywords":55,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":67},"100565218","phimume-percutaneous-left-ventricular-assist-system-study-100565218","NCT06639321","Phimume® Percutaneous Left Ventricular Assist System Study","The Safety and Efficacy of the Percutaneous Left Ventricular Assist System Versus ECMO for Intraoperative Circulatory Support During High-risk Percutaneous Coronary Intervention (PCI): a Prospective, Multi-center, Randomized Controlled Study","Inclusion Criteria:\n\n1. 18 years old≤ patient age ≤90 years old AND patient is not in pregnancy or lactation;\n2. Patients who have been evaluated by two or more cardiovascular surgeons as unsuitable for conventional surgery; or patients who have refused conventional surgery after adequate communication from the surgeon and who are at high risk for conventional surgery;\n3. Left Ventricular Ejection Fraction (LVEF) ≤ 35% AND at least one of the following criteria:\n\n   * Intervention on the last patent coronary conduit, or\n   * Intervention on an unprotected left main coronary artery Or b) LVEF ≤ 30% and intervention in patient presenting with triple vessel disease.\n4. Patient who can understand the purpose of the trial and volunteer to participate in, sign the informed consent form and are willing to accept relevant examinations and clinical follow-ups.\n\nExclusion Criteria:\n\n1. Pre-procedure cardiac arrest within 24 hours of enrolment requiring CPR;\n2. Pre-procedure ST-segment myocardial infarction within 24 hours of enrolment;\n3. Patient is in cardiogenic shock;\n4. Mural thrombus in the left ventricle;\n5. Post-infarction ventricular septal rupture, or atrial septal or ventricular septal defects;\n6. The presence of mechanical aortic or mitral valve or heart constrictive device;\n7. The presence of aortic stenosis (aortic orifice area ≤1.5cm²)；\n8. The presence of moderate to severe aortic or mitral or tricuspid insufficiency;\n9. The presence of severe peripheral vascular disease that would preclude the placement of the percutaneous mechanical circulatory assist device;\n10. Severe aortic diseases such as aortic dissection and aortic aneurysm;\n11. Active infective endocarditis or other active infections;\n12. Chronic renal insufficiency (creatinine clearance≤30ml\u002Fmin);\n13. Liver dysfunction (elevation of liver enzymes and bilirubin levels to ≥3xULN or INR≥2);\n14. The presence of uncorrectable abnormal coagulation (platelet count≤75,000\u002Fmm\\^3 or INR≥2.0 or fibrinogen≤1.50 g\u002Fl);\n15. The presence of uncorrected moderate to severe anemia (hemoglobin \\\u003C90 g\u002FL);\n16. History of stroke or TIA within 1 month of enrolment;\n17. Allergy or intolerance to contrast media, anticoagulant and antiplatelet drugs (e.g., bivalirudin, low molecular heparin, aspirin, clopidogrel, Ticagrelor, etc.);\n18. Severe pulmonary artery hypertension (pulmonary artery systolic pressure \\>70 mmHg);\n19. Participation in clinical trials of other drugs or medical devices prior to enrollment that have not yet reached the primary outcome of research;\n20. Patient with poor compliance and could not complete the study as required determined by the investigator.","18 Years","90 Years",{"count":50,"type":20},250,[23],"The primary purpose of this clinical trial is to evaluate the safety and efficacy of the percutaneous left ventricular assist system versus extracorporeal membrane oxygenation (ECMO) for circulatory support during high-risk PCI.",[54],"Coronary Artery Disease",[56,57],"Percutaneous Ventricular Assist System","high-risk PCI","NOT_YET_RECRUITING","2024-10-10",{"date":61,"type":31},"2024-10-15",{"date":63,"type":20},"2024-10-14",{"date":65,"type":20},"2026-10-14",{"name":37,"class":38},6,{"id":69,"slug":70,"hasResults":11,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":4,"eligibilityCriteria":74,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":75,"targetDuration":4,"studyType":21,"phases":77,"briefSummary":78,"conditions":79,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":89},"100505674","prizvalve-pro-transcatheter-aortic-valve-replacement-study-100505674","NCT05864456","Prizvalve Pro™ Transcatheter Aortic Valve Replacement Study","Evaluation of the Safety and Efficacy of the Prizvalve Pro™ Transcatheter Aortic Valve System in the Treatment of Patients With Severe Aortic Valve Stenosis Disease at High Surgical Risk","Inclusion Criteria:\n\n1. Age ≥ 65 years ;\n2. Patients with symptomatic severe aortic valve stenosis (evaluated by echocardiography: transaortic valve pressure gradient ≥40mmHg (1mmHg=0.133kPa), or transaortic valve blood flow rate ≥4m\u002Fs, or aortic Valve area\\\u003C1.0cm², or AVA \\\u003C0.5cm² \u002Fm²);\n3. Cardiac function NYHA ≥ II;\n4. Life expectancy\\> 12 months;\n5. Patients who are anatomically suitable for transcatheter aortic valve implantation;\n6. Patients who have been evaluated by two or more cardiovascular surgeons as unsuitable for conventional surgery; or patients who have refused conventional surgery after adequate communication from the surgeon and who are at high risk for conventional surgery;\n7. Patients who can understand the purpose of the trial and volunteer to participate in, sign the informed consent form and are willing to accept relevant examinations and clinical follow-ups.\n\nExclusion Criteria:\n\n1. Acute myocardial infarction occurred within 1 month before this treatment;\n2. Congenital unicuspid aortic valve;\n3. Any therapeutic cardiac operation that is performed within 30 days of the index procedure (Previous PCI or implantation of a permanent pacemaker are not considered exclusion criteria);\n4. Patients with other prosthetic heart valves, prosthetic rings already implanted in the heart, or severe mitral valve closure insufficiency (\\>3+);\n5. Patients with hematologic disorders or abnormalities that make surgical treatment inappropriate;\n6. Untreated severe coronary artery stenosis that requires revascularization;\n7. Patients with hemodynamic or respiratory instability, requiring continuous mechanical heart assistance or mechanical ventilation;\n8. Patients who need emergency surgery for any reason;\n9. Patients with hypertrophic cardiomyopathy with obstruction;\n10. Severe left ventricular dysfunction, left ventricular ejection fraction (LVEF) \\\u003C20%;\n11. Echocardiographic evidence of intracardiac mass, thrombus or vegetation;\n12. Patients with left ventricular outflow tract obstruction;\n13. A history of acute peptic ulcer or upper gastrointestinal bleeding within 3 months;\n14. Patients who are allergy or resistance to cobalt-chromium alloy, contrast agents and related components;\n15. Patients who are unable to receive anticoagulation or antiplatelet therapy;\n16. Cerebrovascular accident occurred within 3 months, not including transient ischemic attack;\n17. Severe aortic diseases, including abdominal aortic or thoracic aortic aneurysm, etc;\n18. Active infective endocarditis or other active infections;\n19. Patients who have participated in clinical trials of other drugs or medical devices before enrollment and have not yet reached the primary outcome of research;\n20. The investigator judged that patient with poor compliance and could not complete the study as required.",{"count":76,"type":20},73,[23],"The purpose of this clinical trial is to evaluate the safety and efficacy of the Prizvalve Pro™ transcatheter aortic valve system in the treatment of patients with severe aortic stenosis who are at high risk of surgery or who are not suitable for surgery.",[80],"Aortic Valve Stenosis","2023-11-14",{"date":83,"type":31},"2023-11-18",{"date":85,"type":31},"2023-07-05",{"date":87,"type":20},"2028-05",{"name":37,"class":38},1,{"id":91,"slug":92,"hasResults":11,"nctId":93,"briefTitle":94,"officialTitle":95,"acronym":4,"eligibilityCriteria":96,"healthyVolunteers":11,"sex":16,"minAge":47,"maxAge":4,"enrollmentInfo":97,"targetDuration":4,"studyType":21,"phases":99,"briefSummary":100,"conditions":101,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":104,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":89},"100460397","prizvalve-transcatheter-atrioventricular-valve-replacement-study-100460397","NCT05275088","Prizvalve® Transcatheter Atrioventricular Valve Replacement Study","An Exploratory Study to Evaluate the Prizvalve® System in Patients With Severe Atrioventricular Annular Calcification or Failed Prosthetic Atrioventricular Valve\u002F Annulus Repair","1\\. Inclusion criteria for patients with severe atrioventricular valve annular calcification:\n\n1. Atrioventricular valve annular calcification with moderate or severe atrioventricular valve disease (stenosis, regurgitation, or mixed);\n2. Patient with symptoms, and NYHA Functional Class≥Ⅱ;\n3. 18 years and older who is not in pregnancy or lactation;\n4. Life expectancy\\>12 months;\n5. Patient who is anatomically suitable for transcatheter atrioventricular valve replacement;\n6. According to the evaluation of the heart team, the patient can benefit from transcatheter atrioventricular valve replacement;\n7. The patient can understand the purpose of the trial, voluntarily participate in and sign the informed consent form, and is willing to accept relevant examinations and clinical follow-ups;\n8. Patient with high risk of routine surgery (STS\\>8%) or severe comorbidities that is not suitable for surgery, or with severely calcified valve annulus that cannot be operated.\n\n2\\. Inclusion criteria for patients with failed prosthetic atrioventricular valve\u002Fannulus repair:\n\n1. The patient has undergone atrioventricular valve replacement or valve annulus repair in the past, accompanied by severe atrioventricular valve regurgitation or stenosis;\n2. The patient is symptomatic with NYHA Functional Class≥II or hemolytic anemia requiring blood transfusion (no other causes of hemolytic anemia were found after examination);\n3. 18 years and older who is not in pregnancy or lactation;\n4. Patient who is anatomically suitable for transcatheter atrioventricular valve replacement;\n5. According to the evaluation of the heart team, the patient can benefit from transcatheter atrioventricular valve replacement;\n6. The patient can understand the purpose of the trial, voluntarily participate in and sign the informed consent form, and is willing to accept relevant examinations and clinical follow-ups;\n7. Patient with high risk of routine surgery (STS\\>8%) or severe comorbidities that is not suitable for surgery.\n\nExclusion criteria:\n\n1. Evidence of an acute myocardial infarction \\\u003C1 month(30 days) before the intended treatment;\n2. Any therapeutic cardiac operation (excluding previous PCI and pacemaker implantation) is performed within 30 days of the index procedure;\n3. Patient with planned concomitant surgical or transcatheter ablation for atrial fibrillation;\n4. Patient with hypertrophic cardiomyopathy with obstruction;\n5. Severe left ventricular dysfunction with left ventricular ejection fraction (LVEF) \\\u003C20%;\n6. Echocardiographic evidence of intracardiac mass, thrombus or vegetation;\n7. Acute peptic ulcer or upper gastrointestinal bleeding within 3 months prior to procedure;\n8. Allergy to cobalt-chromium alloy or contrast agent; inability to tolerate anticoagulation and antiplatelet therapy;\n9. Active stage of infective endocarditis or other active infection;\n10. Cerebrovascular accident within 3 months prior to procedure, excluding transient ischemic attack;\n11. Patient with poor compliance and could not complete the study as required.",{"count":98,"type":20},15,[23],"To evaluate the safety and performance of the Prizvalve® system in patients with severe atrioventricular annular calcification or failed prosthetic atrioventricular valve\u002F annulus repair.",[102,103],"Atrioventricular Annular Calcification","Failed Prosthetic Atrioventricular Valve\u002F Annulus Repair",{"date":83,"type":31},{"date":106,"type":31},"2022-03-09",{"date":108,"type":20},"2028-06-10",{"name":37,"class":38},{"id":111,"slug":112,"hasResults":11,"nctId":113,"briefTitle":114,"officialTitle":115,"acronym":4,"eligibilityCriteria":116,"healthyVolunteers":11,"sex":16,"minAge":117,"maxAge":4,"enrollmentInfo":118,"targetDuration":4,"studyType":21,"phases":120,"briefSummary":121,"conditions":122,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":124,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":129,"locationsCount":89},"100440923","valveclip-transcatheter-mitral-valve-repair-study-100440923","NCT05021614","Valveclip® Transcatheter Mitral Valve Repair Study","Evaluation of the Efficacy and Safety of the Transcatheter Mitral Valve Repair System in Patients With Moderate and Above Degenerative Mitral Regurgitation at High Surgical Risk","Inclusion Criteria:\n\n1. Severe mitral regurgitation≥3+ (moderate or above degenerative mitral regurgitation disease, or with stenosis is included);\n2. Age≥70 years; or patients who are 60\\~70 years old, and the STS risk score indicate that participants are at high risk of traditional surgery or cannot tolerate traditional thoracotomy;\n\n4\\) Left ventricular ejection fraction≥30%； 5) As assessed by multidisciplinary cardiac team (at least two cardiac surgeons\u002Fone cardiologist), patients who are at extremely high-risk or unsuitable for routine mitral valve surgery with evaluation; 6) Patients who understand the purpose of the trial and volunteer to participate in, sign the informed consent form and are willing to accept relevant examinations and clinical follow-ups.\n\nAnatomy selection Criteria：\n\n1. The regurgitant jet of mitral valve originates from the A2 and P2 (the lesions of A2\u002FP2 in mitral valve causes regurgitation);\n2. The width of the mitral valve prolapsed area is ≤15mm, Height of Prolapse ≤10mm or coaptation depth≤11mm, coaptation height≥2mm, effective length of anterior and posterior leaflets\\>1cm (conforming to EVEREST II recommended mitral valve interventional edge-to-edge repair standards);\n3. Effective mitral valve orifice area≥ 4.0cm2;\n4. No obvious calcification of the mitral valve annulus and valve leaflets;\n5. Patient's anatomical conditions allow transseptal approach.\n\nExclusion Criteria:\n\n1. Previous cardiac mitral valve surgery;\n2. Patients with Infective endocarditis or having an active infection;\n3. Patients with mitral regurgitation caused by pure mitral stenosis;\n4. Combined with untreated severe coronary artery disease\n5. Pulmonary hypertension (pulmonary artery systolic pressure\\>70mmHg);\n6. Patients with severe right heart failure;\n7. Patients are extremely weak and cannot tolerate general anesthesia or are in shock that circulatory support is needed;\n8. Patients with hypertrophic cardiomyopathy, restrictive cardiomyopathy, and constrictive pericarditis;\n9. Patients receiving chronic dialysis;\n10. Patients with clear coagulation dysfunction and severe coagulopathy;\n11. Patients with clear contraindications to anticoagulant drugs;\n12. Patients with stroke or transient ischemic attack within 30 days;\n13. Echocardiography found any intracardiac mass, left ventricle or atrial thrombus;\n14. Patients who require surgery or interventional therapy for other valvular lesions;\n15. Patients with severe macrovascular lesions requiring surgical treatment;\n16. Patients' imaging examinations suggest that the anatomy of the heart and valves are inappropriate;","60 Years",{"count":119,"type":20},150,[23],"The purpose of this clinical trial is to evaluate the effectiveness and safety of the transcatheter mitral valve repair system in the treatment of patients with moderate or above degenerative mitral regurgitation.",[123],"Mitral Regurgitation",{"date":83,"type":31},{"date":126,"type":31},"2021-09-24",{"date":128,"type":20},"2027-09",{"name":37,"class":38},""]