[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100619365":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":12,"centralContacts":17,"locations":25,"responsibleParty":186,"collaborators":188,"id":192,"slug":193,"hasResults":194,"nctId":195,"briefTitle":196,"officialTitle":196,"acronym":197,"eligibilityCriteria":198,"healthyVolunteers":194,"sex":199,"minAge":200,"maxAge":10,"enrollmentInfo":201,"targetDuration":204,"studyType":205,"phases":10,"briefSummary":206,"conditions":207,"keywords":209,"overallStatus":28,"whyStopped":10,"lastUpdateSubmitDate":218,"lastUpdatePostDateStruct":219,"startDateStruct":222,"completionDateStruct":224,"leadSponsor":226,"locationsCount":227},{"fullName":5,"class":6},"Portuguese Association of Interventional Cardiology","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":10},"Patients with severe aortic stenosis undergoing Medtronic Evolut FX+ TAVI System",null,"Subjects with severe, symptomatic aortic stenosis (AS) with indication for TAVI (Transcatheter Aortic Valve Implant) with the Medtronic Evolut™ FX+ TAVI System - registry of routine practice.",[13],{"name":14,"affiliation":15,"role":16},"Rui C Teles, MD, PhD","Hospital de Santa Cruz - Unidade Local de Saúde de Lisboa Ocidental","PRINCIPAL_INVESTIGATOR",[18,22],{"name":14,"role":19,"phone":20,"phoneExt":10,"email":21},"CONTACT","(+351) 210 433 069","rcteles@outlook.com",{"name":23,"role":19,"phone":10,"phoneExt":10,"email":24},"Joana D Silva, MD, PhD","secretariado.apic@spc.pt",[26,44,56,71,82,93,105,116,127,142,157,171],{"facility":27,"status":28,"city":29,"state":30,"zip":31,"country":32,"countryCode":33,"cosmosGeoPoint":34,"geoPoint":39,"contacts":40},"Hospitais da Universidade de Coimbra","RECRUITING","Coimbra","Coimbra 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MD","jbraga@ulsge.min-saude.pt",{"name":168,"role":16,"phone":10,"phoneExt":10,"email":10},{"facility":172,"status":46,"city":173,"state":174,"zip":175,"country":32,"countryCode":33,"cosmosGeoPoint":176,"geoPoint":180,"contacts":181},"Hospital do Espírito Santo de Évora","Evora","Évora District","7000-811",{"type":35,"coordinates":177},[178,179],-7.90405,38.56587,{"lat":179,"lon":178},[182,185],{"name":183,"role":19,"phone":10,"phoneExt":10,"email":184},"Lino Patrício, MD, PhD","linopatricio@gmail.com",{"name":183,"role":16,"phone":10,"phoneExt":10,"email":10},{"type":187,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[189],{"name":190,"class":191},"Medtronic","INDUSTRY","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":202,"type":203},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.",[208],"Severe Symptomatic Aortic Stenosis (Defined as New York Heart Association (NYHA) Class ≥ II)",[210,211,212,213,214,215,216,217],"TAVI","Transcatheter Aortic Valve Implantation","Evolut FX+","Aortic Stenosis","Cusp Overlap Technique","Conduction Disorders","Evolut FX+ TAVI System","TAVI System","2026-07-01",{"date":220,"type":221},"2026-07-02","ACTUAL",{"date":223,"type":221},"2026-01-14",{"date":225,"type":203},"2028-04",{"name":5,"class":6},12]