[{"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":43},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":4,"hasResults":10,"nctId":11,"briefTitle":12,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":21,"briefSummary":23,"conditions":24,"keywords":26,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":5},"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":18,"type":19},10,"ESTIMATED","INTERVENTIONAL",[22],"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",[25],"Aortic Stenosis Symptomatic",[27,28,29,30],"aortic stenosis","TAVI","TAVR","Function of bending","NOT_YET_RECRUITING","2024-12-03",{"date":34,"type":35},"2024-12-06","ACTUAL",{"date":37,"type":19},"2024-12",{"date":39,"type":19},"2025-06-30",{"name":41,"class":42},"Peijia Medical Technology (Suzhou) Co., Ltd.","INDUSTRY",""]