[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"severe-symptomatic-aortic-stenosis-defined-as-new-york-heart-association-nyha-class--ii\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:severe-symptomatic-aortic-stenosis-defined-as-new-york-heart-association-nyha-class--ii":25},{"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":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":21,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":26,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100619365","perfect---portuguese-evolut-registry-studying-the-outcomes-of-medtronic-evolut-fx-tavi-system-by-evaluating-an-optimal-care-pathway-for-tavi-100619365",false,"NCT07343674","PERFECT - Portuguese Evolut Registry Studying the Outcomes of Medtronic Evolut™ FX+ TAVI System by Evaluating an Optimal Care Pathway for TAVI","PERFECT","Inclusion Criteria:\n\n* Subjects more than 18 years old, able to provide an Informed Consent:\n* Severe symptomatic (defined as New York Heart Association (NYHA) class ≥ II) aortic stenosis (AS), including but not limited to: Dyspnea at rest or on exertion, fatigue, angina, syncope in the absence of another identifiable cause;\n* Subjects provided written Informed Consent as approved by the Ethics Committee (EC);\n\nExclusion Criteria:\n\n* Subjects with pre-existing surgical bioprosthetic aortic valve;\n* Hepatic insufficiency (Child-Pugh Class B or C);\n* Contraindicated for treatment with the Medtronic Evolut™ FX+ TAVU System in accordance with the Instructions for Use (IFU);\n* Anatomically considered not suitable for the Medtronic Evolut™ FX+ TAVI system;\n* Subjects are currently participating in another clinical investigation that may confound the results of this Registry;\n* Subjects have an expected survival less than one year.","ALL","18 Years",{"count":19,"type":20},500,"ESTIMATED","1 Year","OBSERVATIONAL","The goal of this registry is to learn how the Medtronic Evolut™ FX+ transcatheter aortic valve implantation (TAVI) System performs in adults with severe, symptomatic aortic stenosis who need valve replacement.\n\nThe main questions it aims to answer are:\n\n* Can using a standardized procedure for the impantation of the Medtronic Evolut™ FX+ TAVI System increase safety and efficiency?\n* What are the short-term (30 days) and long-term (1 year) patient outcomes, including the need for a pacemaker, complications, and valve function?\n\nParticipants will undergo TAVI with the Medtronic Evolut™ FX+ TAVI System as part of their routine care.\n\nBe followed during their hospital stay, at 30 days, and at 1 year to check heart health, valve function, and recovery. 500 people at 12 hospitals in Portugal will take part in this registry.",[25],"Severe Symptomatic Aortic Stenosis (Defined as New York Heart Association (NYHA) Class ≥ II)",[27,28,29,30,31,32,33,34],"TAVI","Transcatheter Aortic Valve Implantation","Evolut FX+","Aortic Stenosis","Cusp Overlap Technique","Conduction Disorders","Evolut FX+ TAVI System","TAVI System","RECRUITING","2026-07-01",{"date":38,"type":39},"2026-07-02","ACTUAL",{"date":41,"type":39},"2026-01-14",{"date":43,"type":20},"2028-04",{"name":45,"class":46},"Portuguese Association of Interventional Cardiology","OTHER",12]