[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100491007":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":24,"locations":30,"responsibleParty":43,"collaborators":11,"id":46,"slug":47,"hasResults":48,"nctId":49,"briefTitle":50,"officialTitle":50,"acronym":11,"eligibilityCriteria":51,"healthyVolunteers":48,"sex":52,"minAge":53,"maxAge":11,"enrollmentInfo":54,"targetDuration":11,"studyType":57,"phases":58,"briefSummary":60,"conditions":61,"keywords":63,"overallStatus":66,"whyStopped":11,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":76},{"fullName":5,"class":6},"Chinese Academy of Medical Sciences, Fuwai Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Treatment Group","EXPERIMENTAL",null,[13],"Device: Transcatheter Aortic Valve Implantation (KOKA-VALVE)",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":11},"DEVICE","Transcatheter Aortic Valve Implantation (KOKA-VALVE)","Transcatheter Aortic Valve Implantation",[9],[21],{"name":22,"affiliation":5,"role":23},"Xiangbin Pan","PRINCIPAL_INVESTIGATOR",[25],{"name":26,"role":27,"phone":28,"phoneExt":11,"email":29},"Chunrui Xiang","CONTACT","+86 17601425727","crxiang@kokalife.com",[31],{"facility":32,"status":11,"city":33,"state":34,"zip":11,"country":35,"countryCode":36,"cosmosGeoPoint":37,"geoPoint":42,"contacts":11},"Structral Heart Disease Center, Fuwai Hospital","Beijing","Beijing Municipality","China","CN",{"type":38,"coordinates":39},"Point",[40,41],116.39723,39.9075,{"lat":41,"lon":40},{"type":23,"investigatorFullName":44,"investigatorTitle":45,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"Pan Xiangbin","Chief, Department of Structural Heart DiseaseAffiliation","100491007","a-clinical-trial-of-the-transcatheter-aortic-valve-implantation-system-with-a-prospective-multi-center-one-arm-approach-to-evaluate-the-efficacy-and-safety-in-the-treatment-of-patients-with-severe-aortic-stenosis-100491007",false,"NCT05673525","A Clinical Trial of the Transcatheter Aortic Valve Implantation System With a Prospective, Multi-Center, One-Arm Approach to Evaluate the Efficacy and Safety in the Treatment of Patients With Severe Aortic Stenosis","Inclusion Criteria:\n\n* Contraindication to surgery, or high risk for surgery (STS ≥ 8%) as assessed by the heart team; or other circumstances that make surgical valve replacement inappropriate.\n* Age ≥65 years.\n* Patients with symptomatic severe aortic stenosis (mean aortic transvalvular gradient by echocardiography ≥40 mmHg (1 mmHg=0.133 kPa), or transaortic flow velocity ≥4.0 m\u002Fs, or aortic valve orifice area \\\u003C0.8 cm2, or effective aortic orifice area index \\\u003C0.5 cm2 \u002Fm2).\n* The subjects have been informed of the nature of this study, understand the purpose of the clinical trial, and voluntarily participate in and sign the informed consent form.\n\nExclusion Criteria:\n\n* Life expectancy less than 1 year after implantation of the prosthetic valve.\n* Patients had an acute heart attack within 1 month, or had a coronary stent or a pacing device implantation within 1 month, or had any therapeutic cardiac surgery within 1 month.\n* Patients with aortic root anatomy and lesion that are not suitable for prosthetic valve implantation.\n* Combined with severe insufficiency or stenosis of other valves and requiring surgical treatment.\n* Hematologic cachexia, including leukopenia (WBC \\\u003C3×10\\^9 \u002FL), acute anemia (HB \\\u003C90 g\u002FL), thrombocytopenia (PLT \\\u003C50 × 10\\^9 \u002FL), bleeding constitution, and coagulation disorders.\n* Untreated coronary artery disease requiring hematologic reconstruction.\n* Hypertrophic obstructive cardiomyopathy.\n* Severe left ventricular dysfunction with left ventricular ejection fraction (LVEF) \\\u003C20%.\n* Severe right ventricular insufficiency.\n* The existent of intracardiac masses, thrombi or superfluous organisms by echocardiography.\n* Patients who cannot tolerate anticoagulation or antiplatelet therapy.\n* Patients had cerebrovascular event (CVA), including ischemic stroke and hemorrhagic stroke within 3 months.\n* Decompensation of renal insufficiency.\n* Active infective endocarditis or other active infection.\n* Untreated conduction system disease requiring pacemaker implantation.\n* Currently participating in an investigational drug or another device study that has not completed its primary endpoints or would clinically interfere with the endpoint of this study.\n* Other circumstances that are assessed by the investigator to be unsuitable for interventional aortic valve therapy.","ALL","65 Years",{"count":55,"type":56},131,"ESTIMATED","INTERVENTIONAL",[59],"NA","A Clinical Trial of the Transcatheter Aortic Valve Implantation System with a Prospective, Multi-Center, One-Arm Approach to Evaluate the Efficacy and Safety in the Treatment of Patients with Severe Aortic Stenosis",[62],"Aortic Stenosis",[64,65],"Heart Valve Disease","Cardiovascular Diseases","NOT_YET_RECRUITING","2023-01-05",{"date":69,"type":70},"2023-01-06","ACTUAL",{"date":72,"type":56},"2022-12-30",{"date":74,"type":56},"2028-12-30",{"name":5,"class":6},1]