[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"aortic-stenosis-symptomatic\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:aortic-stenosis-symptomatic":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"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":27,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":5},"100571547","study-of-transcatheter-aortic-valve-replacement-with-a-flex-and-commissural-alignment-technology-in-severe-aortic-stenosis-100571547",false,"NCT06721676","Study of Transcatheter Aortic Valve Replacement With A² Flex and Commissural Alignment Technology in Severe Aortic Stenosis","A Prospective, Single-center, Single-group Follow-up Study of Transcatheter Aortic Valve Replacement With A² Flex and Commissural Alignment Technology in Severe Aortic Stenosis by Peijia Medical","Inclusion Criteria:\n\n* Patients who are willing to participate and sign the informed consent and can cooperate with the whole trial process;\n* Age ≥60 years old;\n* Patients with severe calcified aortic stenosis confirmed by echocardiography (trans-aortic valve flow velocity ≥ 4.0m \u002Fs, or trans-active valvular pressure difference ≥40mmHg (1mmHg=0.133kPa), or aortic valve orientation area \\\u003C 0.8cm2, or effective aortic valve orifice the product index is \\\u003C 0.5cm2\u002Fm2);\n* The cardiac team (at least two specialists in cardiovascular surgery) assessed the patient as unsuitable for routine surgery ;\n* The aortic angel ≥60 degree.\n\nExclusion Criteria:\n\n* The left and right coronary ostiums originate from the junctional zone or from both coronary ostiums;\n* previous CABG history;\n* Coronary ostial lesions（PCI or not）;\n* Prior aortic valve prosthesis implantation (interventional\u002Fsurgical, bioprosthetic\u002Fmechanical);\n* Spoor peripheral arterial condition precluded transfemoral TAVR;\n* Severe coronary stenoses requiring intervention for which concomitant PCI is not possible;\n* Concomitant diseases requiring cardiac surgery;\n* Other serious diseases that may reduce life expectancy to less than 12 months (e.g. clinically recurrent or metastatic cancer, congestive heart failure, etc.);\n* contraindications to conventional cardiac catheterization, such as intracardiac thrombosis, infection, outflow obstruction, hypertrophic cardiomyopathy, etc;\n* other surgical anatomical contraindications, such as the risk of coronary artery occlusion;\n* clinically significant active bleeding\n* platelet count \\\u003C 30×10\u002F L;\n* participating in other drug or medical device clinical studies that have not yet been completed ;\n* considered inappropriate by the investigator to participate in the clinical study.","ALL","60 Years",{"count":19,"type":20},10,"ESTIMATED","INTERVENTIONAL",[23],"NA","A prospective, single-center, single-group follow-up study of transcatheter aortic valve replacement with A² Flex and commissural alignment technology in severe aortic stenosis by Peijia Medical",[26],"Aortic Stenosis Symptomatic",[28,29,30,31],"aortic stenosis","TAVI","TAVR","Function of bending","NOT_YET_RECRUITING","2024-12-03",{"date":35,"type":36},"2024-12-06","ACTUAL",{"date":38,"type":20},"2024-12",{"date":40,"type":20},"2025-06-30",{"name":42,"class":43},"Peijia Medical Technology (Suzhou) Co., Ltd.","INDUSTRY"]