[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100649417":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":20,"locations":20,"responsibleParty":21,"collaborators":20,"id":23,"slug":24,"hasResults":25,"nctId":26,"briefTitle":27,"officialTitle":27,"acronym":28,"eligibilityCriteria":29,"healthyVolunteers":25,"sex":30,"minAge":31,"maxAge":32,"enrollmentInfo":33,"targetDuration":20,"studyType":36,"phases":37,"briefSummary":39,"conditions":40,"keywords":43,"overallStatus":47,"whyStopped":20,"lastUpdateSubmitDate":48,"lastUpdatePostDateStruct":49,"startDateStruct":52,"completionDateStruct":54,"leadSponsor":56,"locationsCount":20},{"fullName":5,"class":6},"Onecrea Medical Inc.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Investigational TAVR Device","EXPERIMENTAL","Participants will receive the investigational transcatheter aortic valve replacement (TAVR) system for the treatment of severe symptomatic native aortic valve stenosis according to the Clinical Investigation Plan.",[13],"Device: Investigational Transcatheter Aortic Valve Replacement System",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","Investigational Transcatheter Aortic Valve Replacement System","Investigational transcatheter bioprosthetic aortic valve replacement system intended for treatment of severe symptomatic native aortic valve stenosis.",[9],null,{"type":22,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100649417","a-prospective-multi-centre-single-arm-pivotal-clinical-study-to-determine-the-safety-and-effectiveness-of-crea-aortic-valve-for-use-as-a-replacement-aortic-heart-valve-100649417",false,"NCT07734025","A Prospective, Multi-centre, Single Arm, Pivotal Clinical Study to Determine the Safety and Effectiveness of Crea Aortic Valve for Use as a Replacement Aortic Heart Valve","CREATE","Inclusion Criteria:\n\n* Age 60 years or older.\n* Symptomatic severe native calcific aortic valve stenosis.\n* Considered appropriate for transcatheter aortic valve replacement (TAVR) by the local Heart Team.\n* Considered at high surgical risk for surgical aortic valve replacement.\n* Able to understand the study requirements and provide written informed consent.\n* Willing and able to comply with all study procedures and follow-up visits.\n\nExclusion Criteria:\n\n* Contraindication to transcatheter aortic valve replacement or the investigational procedure.\n* Active infection or endocarditis.\n* Life expectancy less than one year due to non-cardiac comorbidities.\n* Participation in another investigational study that could interfere with the objectives of this study.\n* Any medical, anatomical, or clinical condition that, in the opinion of the investigator or Heart Team, would make study participation inappropriate or place the subject at unacceptable risk.","ALL","60 Years","80 Years",{"count":34,"type":35},30,"ESTIMATED","INTERVENTIONAL",[38],"NA","This is a prospective, multicenter, single-arm clinical investigation designed to evaluate the safety and performance of an investigational transcatheter aortic valve replacement system in patients with symptomatic severe native aortic valve stenosis who are considered appropriate candidates for transcatheter valve replacement. Eligible subjects will be enrolled at multiple investigational sites and followed according to the clinical investigation plan.\n\nThe study will assess procedural success, device performance, and clinical safety using predefined clinical and echocardiographic outcome measures. Subjects will undergo scheduled follow-up evaluations to assess device performance, functional status, quality of life, and the occurrence of adverse clinical events over the study period.",[41,42],"Aortic Valve Stenosis","Severe Aortic Stenosis",[44,45,46,41],"Transcatheter Aortic Valve Replacement","TAVR","Transcatheter Aortic Valve Implantation","NOT_YET_RECRUITING","2026-07-24",{"date":50,"type":51},"2026-07-29","ACTUAL",{"date":53,"type":35},"2026-12-04",{"date":55,"type":35},"2033-06-30",{"name":5,"class":6}]