[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100486168":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":27,"responsibleParty":44,"collaborators":46,"id":54,"slug":55,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":20,"eligibilityCriteria":60,"healthyVolunteers":56,"sex":61,"minAge":62,"maxAge":20,"enrollmentInfo":63,"targetDuration":20,"studyType":66,"phases":67,"briefSummary":69,"conditions":70,"keywords":20,"overallStatus":30,"whyStopped":20,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":81},{"fullName":5,"class":6},"Peijia Medical Technology (Suzhou) Co., Ltd.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"A single set of test","EXPERIMENTAL","The HighLife Trans-Septal TMVR System comprises a 28mm Transcatheter Mitral Valve, a loop placement catheter, a sub-annular implant and its delivery systems.",[13],"Device: the HighLife Trans-Septal Transcatheter Mitral Valve Replacement System",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","the HighLife Trans-Septal Transcatheter Mitral Valve Replacement System","The HighLife TMVR system is composed of a Transcatheter Mitral Valve (TMV), a subannular implant (SAI), and their delivery systems and accessories. The TMV is a 28mm mitral bioprosthesis made of a self-expanding Nitinol frame covered with polyester graft and supporting bovine pericardium leaflets. The bioprosthesis is used in conjunction with the Sub-Annular Implant (SAI), comprising a ring (made of polycarbonate urethane (PCU), nitinol, gold markers and polyester (Dacron) to be placed around the mitral valve apparatus to stabilize the position of the mitral valve implant.",[9],null,[22],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},"Kejing Yi","CONTACT","+86-13801858760","yikejing@peijiamedical.com",[28],{"facility":29,"status":30,"city":31,"state":32,"zip":33,"country":34,"countryCode":35,"cosmosGeoPoint":36,"geoPoint":41,"contacts":42},"Peiga Medical Technology (Suzhou) Co.","RECRUITING","Suzhou","Jiangsu","215025","China","CN",{"type":37,"coordinates":38},"Point",[39,40],120.59538,31.30408,{"lat":40,"lon":39},[43],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},{"type":45,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR",[47,50,52],{"name":48,"class":49},"West China Hospital","OTHER",{"name":51,"class":49},"Second Affiliated Hospital, School of Medicine, Zhejiang University",{"name":53,"class":49},"The Second Affiliated Hospital of Harbin Medical University","100486168","safety-and-efficacy-of-the-highlife-transcatherter-mitral-valve-replacement-system-in-patients-with-moderate-severe-or-severe-mitral-regurgitation-in-china-100486168",false,"NCT05610566","Safety and Efficacy of the HighLife Transcatherter Mitral Valve Replacement System in Patients With Moderate-severe or Severe Mitral Regurgitation in China","A Prospective, Multicentric Clinical Trial Protocol to Evaluate the Safety and Efficacy of the HighLife Trans-Septal Transcatheter Mitral Valve Replacement System for the Treatment of Moderate-severe or Severe Mitral Regurgitation With Single-arm Objective Performance Criteria","Inclusion Criteria:\n\n1. Patients who voluntarily participate and sign the informed consent form and can cooperate with the completion of the entire trial process;\n2. Age ≥ 18 years old;\n3. Moderate-severe or severe mitral regurgitation (≥3+); Note 1: Patients with ischemic or non-ischemic heart disease induced symptomatic secondary mitral regurgitation as the primary cause must be treated for at least 1 month after optimal guideline medical therapy (GDMT). Echocardiography should be performed 3 months after cardiac resynchronization therapy and 1 month after coronary revascularization to assess the degree of regurgitation.\n\n   Note 2: For patients with primary mitral regurgitation, the multidisciplinary cardiac team of the research center needs to use a standard scoring system, considering multiple factors such as complications, frailty, and disability, ensuring the enrolled with a high risk of surgery.\n4. Patients with New York Heart Association (NYHA) functional ratings are Class II, III, or ambulatory Class IV;\n5. Anatomically appropriate for treatment with the HighLife Transcatheter Mitral Valve Replacement System.\n\nExclusion Criteria:\n\n1. Patients had any stroke\u002FTIA within 30 days;\n2. Patients with severe symptomatic bilateral carotid stenosis (\\>70% stenosis on non-invasive imaging);\n3. Patients with active infection requiring antibiotic therapy;\n4. Patients with active ulcer or gastrointestinal bleeding within the past 3 months;\n5. Patients with history of coagulopathy or refuse future blood transfusion;\n6. Patients unable to undergo transesophageal echocardiography (TEE);\n7. Patients who are pregnant or breastfeeding, or planning to have children within 12 months;\n8. Patients who are unable to adhere to the follow-up schedule and complete the examination;\n9. Patients enrolled in other clinical studies and within the follow-up period;\n10. Patients with known allergies to device components or contrast agents;\n11. Patients unable to receive anticoagulant or antiplatelet therapy;\n12. Patients with a life expectancy of less than 12 months due to non-cardiac disease;\n13. Patients requiring emergency surgical treatment;\n14. Patients scheduled for cardiac surgery within 12 months;\n15. Patients with an inappropriate mitral annulus or leaflet size (\\\u003C30 mm and \\>45 mm);\n16. Patients with moderate or above mitral stenosis;\n17. Flail mitral leaflets, or moderate to severe mitral valve prolapse;\n18. Patients with severe hepatic or renal insufficiency;\n19. Patients with severe calcification of the mitral annulus and\u002For mitral leaflets;\n20. Patients with history of mitral valve surgery or interventional therapy, or left atrial appendage occlusion device;\n21. Patients had acute myocardial infarction (MI) (Q-wave MI, or non-Q-wave MI, with CK-MB twice the normal and\u002For T-MB) within the past 1 month;\n22. Patients with untreated symptomatic coronary lesions requiring revascularization;\n23. Patients with untreated severe aortic stenosis and severe aortic regurgitation;\n24. Patients with aortic valve prosthesis;\n25. Patients with severe tricuspid valve lesions requiring surgical intervention;\n26. Patients with significant right ventricular dysfunction (such as biliteral lower extremities edema with increased jugular vein pulsation and hepatomegaly;\n27. LVEF \\\u003C 30%; LVEDD \\> 70 mm;\n28. Patients with echocardiographically confirmed intracardiac mass, thrombus or neoplasm;\n29. Hypertrophic obstructive cardiomyopathy (HOCM);\n30. Patients with active or recent (within 3 months) endocarditis;\n31. Patients with definite non-left heart disease induced severe pulmonary hypertension (echocardiographic indication: systolic pulmonary artery pressure (SPAP) \\> 70 mmHg)\n32. Patients with hypotension (systolic blood pressure \\\u003C90 mmHg) occurring within 7 days or mechanical hemodynamic support.","ALL","18 Years",{"count":64,"type":65},110,"ESTIMATED","INTERVENTIONAL",[68],"NA","To observe and evaluate the safety and efficacy of the HighLife Transcatheter Mitral Valve Replacement System in patients with moderate-severe or severe mitral valve regurgitation through a prospective, multicenter clinical trial using objective performance criteria.",[71],"Mitral Regurgitation","2022-11-07",{"date":74,"type":75},"2022-11-09","ACTUAL",{"date":77,"type":75},"2022-07-06",{"date":79,"type":65},"2029-07-06",{"name":5,"class":6},1]