[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100486168":3},{"organization":4,"outcomesModule":7,"designInfo":36,"detailedDescription":39,"studyPopulation":39,"armGroups":43,"interventions":50,"overallOfficials":39,"centralContacts":56,"locations":62,"responsibleParty":79,"collaborators":81,"id":89,"slug":39,"hasResults":90,"nctId":91,"briefTitle":92,"officialTitle":93,"acronym":39,"eligibilityCriteria":94,"healthyVolunteers":90,"sex":95,"minAge":96,"maxAge":39,"enrollmentInfo":97,"targetDuration":39,"studyType":100,"phases":101,"briefSummary":102,"conditions":103,"keywords":39,"overallStatus":65,"whyStopped":39,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":114},{"fullName":5,"class":6},"Peijia Medical Technology (Suzhou) Co., Ltd.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":25},[9],{"measure":10,"description":11,"timeFrame":12},"All-cause mortality at 12 months","All-cause mortality","12 months",[14,18,22],{"measure":15,"description":16,"timeFrame":17},"Technical success","Technical success defined as an alive patient at exit from procedure room, with all of the following:\n\n* Successful vascular access, delivery and retrieval of the HighLife delivery systems\n* Deployment and correct positioning of the HighLife 28mm bioprosthesis\n* Freedom from additional emergency surgery or re-intervention related to the device or access procedure, that occurred (was initiated) during the procedure. Any emergency surgery or re-intervention that occurs after the patient exits the procedure room\u002Fcath lab in stable condition will be captured as an AE\u002FSAE.","Immediate after procedure",{"measure":19,"description":20,"timeFrame":21},"Cardiac function change","NYHA functional classification","30 days, 6 months, 12 months, 2 years, 3 years, 4 years and 5 years",{"measure":23,"description":24,"timeFrame":21},"Quality of life of patients","Quality of Life of patients accessed by EuroQol-5 Dimensions (EQ-5D) Questionnaire. The higher scores mean a worse health state. Recording changes from baseline.",[26,30,33],{"measure":27,"description":28,"timeFrame":29},"Operative complication","The rate of operative complication","Immediately after procedure",{"measure":31,"description":32,"timeFrame":21},"The incidence of major adverse cardiovascular and cerebrovascular events during the trial(MACCEs)","Incidence of MACCEs (mortality, stroke, myocardial infarction, and so on surgery, arrhythmias, conduction blocks) during the trial",{"measure":34,"description":35,"timeFrame":21},"Incidence of major adverse valve-related events (MAVREs) during the trial","including prosthetic valve-related death, permanent cardiac pacemaker implantation, permanent cardiac defibrillator implantation, prosthetic valve embolism, prosthetic valve thrombosis, prosthetic valve dysfunction.",{"allocation":37,"interventionModel":38,"interventionModelDescription":39,"primaryPurpose":40,"observationalModel":39,"timePerspective":39,"maskingInfo":41},"NA","SINGLE_GROUP",null,"TREATMENT",{"masking":42,"maskingDescription":39,"whoMasked":39},"NONE",[44],{"label":45,"type":46,"description":47,"interventionNames":48},"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.",[49],"Device: the HighLife Trans-Septal Transcatheter Mitral Valve Replacement System",[51],{"type":52,"name":53,"description":54,"armGroupLabels":55,"otherNames":39},"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.",[45],[57],{"name":58,"role":59,"phone":60,"phoneExt":39,"email":61},"Kejing Yi","CONTACT","+86-13801858760","yikejing@peijiamedical.com",[63],{"facility":64,"status":65,"city":66,"state":67,"zip":68,"country":69,"countryCode":70,"cosmosGeoPoint":71,"geoPoint":76,"contacts":77},"Peiga Medical Technology (Suzhou) Co.","RECRUITING","Suzhou","Jiangsu","215025","China","CN",{"type":72,"coordinates":73},"Point",[74,75],120.59538,31.30408,{"lat":75,"lon":74},[78],{"name":58,"role":59,"phone":60,"phoneExt":39,"email":61},{"type":80,"investigatorFullName":39,"investigatorTitle":39,"investigatorAffiliation":39,"oldNameTitle":39,"oldOrganization":39},"SPONSOR",[82,85,87],{"name":83,"class":84},"West China Hospital","OTHER",{"name":86,"class":84},"Second Affiliated Hospital, School of Medicine, Zhejiang University",{"name":88,"class":84},"The Second Affiliated Hospital of Harbin Medical University","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":98,"type":99},110,"ESTIMATED","INTERVENTIONAL",[37],"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.",[104],"Mitral Regurgitation","2022-11-07",{"date":107,"type":108},"2022-11-09","ACTUAL",{"date":110,"type":108},"2022-07-06",{"date":112,"type":99},"2029-07-06",{"name":5,"class":6},1]