[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100438358":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":19,"locations":19,"responsibleParty":20,"collaborators":24,"id":28,"slug":29,"hasResults":30,"nctId":31,"briefTitle":32,"officialTitle":32,"acronym":19,"eligibilityCriteria":33,"healthyVolunteers":30,"sex":34,"minAge":19,"maxAge":19,"enrollmentInfo":35,"targetDuration":19,"studyType":38,"phases":39,"briefSummary":41,"conditions":42,"keywords":19,"overallStatus":44,"whyStopped":19,"lastUpdateSubmitDate":45,"lastUpdatePostDateStruct":46,"startDateStruct":49,"completionDateStruct":51,"leadSponsor":53,"locationsCount":19},{"fullName":5,"class":6},"CCRF Inc., Beijing, China","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Prospective and retrospective study of subjects undergoing aortic valve surgery","OTHER","This study is a prospective \u002F retrospective, multicenter, and observational study after listing. The researchers can initially determine that they can be enrolled in the study according to the history diagnosis of the subjects. After fully informed, they sign informed consent form. After the evaluation of the researchers, they meet the TAVR selection requirements, and register the subjects in multiple centers at the same time",[13],"Other: All aortic valve products on the market",[15],{"type":10,"name":16,"description":17,"armGroupLabels":18,"otherNames":19},"All aortic valve products on the market","1. Subjects with severe aortic valve stenosis\n2. Subjects who plan (or have) to use the transcatheter aortic valve replacement system for percutaneous aortic valve replacement\n3. The patients agreed to join the study, voluntarily signed the informed consent and completed the follow-up;\n4. Be able to contact the subjects or their legal guardians \u002F relatives;\n5. The medical record records the subjects who have died and can't get any contact information of the subjects（ (for dead cases only)\n\nSign the informed consent form, then check the inclusion and exclusion criteria, register after meeting the criteria, obtain the registration number, perform aortic valve replacement surgery, follow-up 24 hours, discharge, 30 days, 1 year, 2 years, 3 years, 4 years and 5 years after operation according to the test requirements, and carry out relevant follow-up according to the scheme requirements to collect data",[9],null,{"type":21,"investigatorFullName":22,"investigatorTitle":23,"investigatorAffiliation":5,"oldNameTitle":19,"oldOrganization":19},"PRINCIPAL_INVESTIGATOR","Yaling Han, M.d., Ph.D.","Academlcan\u002Fchief physician",[25],{"name":26,"class":27},"Hangzhou Qiming Medical Instrument Co., Ltd","UNKNOWN","100438358","multi-center-registry-of-transcatheter-aortic-valve-replacement-in-northeast-china-100438358",false,"NCT04988243","Multi Center Registry of Transcatheter Aortic Valve Replacement in Northeast China","Inclusion Criteria:\n\n1. Severe aortic valve stenosis, defined as follows:\n\n   1. Symptomatic patients:\n\n      * The mean differential pressure measured by echocardiography ≥ 40mm Hg\n      * Or peak aortic ejection ≥ 4.0 m \u002F S\n      * Or aortic valve area ≤ 1.0cm ²（ Or AVA index ≤ 0.6 cm2 \u002F m2)\n   2. Asymptomatic patients:\n\n      * Severe aortic stenosis and aortic valve area ≤ 1.0cm ²（ 6 cm2 \u002F m2) with aortic ejection peak value ≥ 5.0 M \u002F s or mean pressure difference measured by --echocardiography ≥ 60 mm Hg;\n      * Or aortic valve area ≤ 1.0cm ²（ Or AVA index ≤ 0.6 cm2 \u002F m2), combined with aortic ejection peak ≥ 4.0 m \u002F s or average differential pressure measured by echocardiography ≥ 40 mm Hg, combined with limited exercise tolerance test, abnormal blood pressure response or arrhythmia;\n      * Or aortic valve area ≤ 1.0cm ²（ Or AVA index ≤ 0.6 cm2 \u002F m2), combined with aortic ejection peak ≥ 4.0 m \u002F s or average differential pressure measured by echocardiography ≥ 40 mm Hg, combined with LVEF \\\u003C 50%\n2. Subjects who plan (or have) to use the transcatheter aortic valve replacement system for percutaneous aortic valve replacement\n3. The patients agreed to join the study, voluntarily signed the informed consent and completed the follow-up;\n4. Be able to contact the subjects or their legal guardians \u002F relatives;\n5. The medical record records the subjects who have died and can't get any contact information of the subjects（ (for dead cases only)\n\nNote: for dead subjects, they must meet 1, 2 and 5 at the same time before they can be included in the group.\n\nExclusion Criteria:\n\n1. Contraindications to any artificial biological valve implantation;\n2. Any known allergies or contraindications;\n\n   * Aspirin or heparin and bivalirudin;\n   * Tigrelol and clopidogrel;\n   * Nickel titanium alloy;\n   * Contrast medium;\n3. The patient is currently participating in drug or device research;\n4. The patient is pregnant or lactating;\n5. Aortic annulus diameter \\\u003C 17 mm or \\> 32 mm;\n6. The diameter of approach vessel was less than 5.0mm;\n7. The investigator believes that the patient is not suitable to participate in this study or complete the follow-up specified in the protocol;","ALL",{"count":36,"type":37},320,"ESTIMATED","INTERVENTIONAL",[40],"NA","The purpose of this study was to observe the safety and effectiveness of transcatheter aortic valve replacement in patients with aortic valve stenosis in a real-world clinical practice environment.",[43],"Severe Aortic Valve Stenosis","NOT_YET_RECRUITING","2021-08-01",{"date":47,"type":48},"2021-08-03","ACTUAL",{"date":50,"type":37},"2021-08",{"date":52,"type":37},"2028-08",{"name":5,"class":6}]