[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100619365":3},{"organization":4,"outcomesModule":7,"designInfo":59,"detailedDescription":60,"studyPopulation":63,"armGroups":64,"interventions":60,"overallOfficials":68,"centralContacts":73,"locations":81,"responsibleParty":242,"collaborators":244,"id":248,"slug":60,"hasResults":249,"nctId":250,"briefTitle":251,"officialTitle":251,"acronym":252,"eligibilityCriteria":253,"healthyVolunteers":249,"sex":254,"minAge":255,"maxAge":60,"enrollmentInfo":256,"targetDuration":259,"studyType":260,"phases":60,"briefSummary":261,"conditions":262,"keywords":264,"overallStatus":84,"whyStopped":60,"lastUpdateSubmitDate":273,"lastUpdatePostDateStruct":274,"startDateStruct":277,"completionDateStruct":279,"leadSponsor":281,"locationsCount":282},{"fullName":5,"class":6},"Portuguese Association of Interventional Cardiology","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":50},[9],{"measure":10,"description":11,"timeFrame":12},"VARC-3 technical success","A composite outcome assessed immediately after the TAVI procedure, including: survival, successful vascular access and device deployment\u002Fretrieval, correct positioning of a single valve, and freedom from major complications or need for surgery\u002Fintervention (excluding pacemaker).","Immediately after the index procedure",[14,18,22,26,29,32,35,38,41,44,47],{"measure":15,"description":16,"timeFrame":17},"Rate of Permanent Pacemaker Implantation (PPI)","Percentage of participants who require a new permanent pacemaker due to new or worsening conduction disturbances.","30 days after procedure",{"measure":19,"description":20,"timeFrame":21},"Length of Hospital Stay","Number of days from TAVI procedure to discharge.","Up to 30 days after procedure",{"measure":23,"description":24,"timeFrame":25},"All-Cause Mortality","Death from any cause.","30 days and 1 year",{"measure":27,"description":28,"timeFrame":25},"Stroke","Any new neurologic deficit classified as a stroke by clinical evaluation.",{"measure":30,"description":31,"timeFrame":25},"Life-Threatening Bleeding","Severe bleeding events defined by VARC-3 criteria.",{"measure":33,"description":34,"timeFrame":25},"Acute Kidney Injury","Kidney dysfunction as defined by VARC-3 criteria.",{"measure":36,"description":37,"timeFrame":25},"Coronary Artery Obstruction","Blockage requiring clinical intervention.",{"measure":39,"description":40,"timeFrame":25},"Major Vascular Complications","Serious vascular complications as defined by VARC-3 criteria",{"measure":42,"description":43,"timeFrame":25},"Valve Dysfunction Requiring Reintervention","Prosthetic valve dysfunction that requires repeat procedure.",{"measure":45,"description":46,"timeFrame":25},"Rehospitalization","Rehospitalization for valve-related symptoms or worsening heart failure.",{"measure":48,"description":49,"timeFrame":25},"Prosthetic Valve Function","Echocardiographic measures of valve function: left ventricular ejection fraction, peak velocity, mean gradient, effective orifice area, indexed effective orifice area, and prosthetic aortic valve regurgitation.\n\nIt is defined as YES if: peak velocity is \\\u003C 3 m\u002Fs AND mean gradient \\\u003C 20 mmHg AND DVI \\> 0,25\\* AND Regurgitation \\\u003C moderate (this means that LV and index EOA are indirectly in it, no cutt offs are needed)\n\n\\* DVI is the ratio of the Velocity-Time Integral (VTI) in the Left Ventricular Outflow Tract (LVOT) to the VTI across the stenotic aortic valve. It is measured based on the peak velocity \u002FGrad, Effective orifice area (cm²)",[51,55],{"measure":52,"description":53,"timeFrame":54},"Procedural Technique Compliance (TAVI.PTrainer Survey)","Assessment of operator adherence to standardized TAVI procedural steps, including Cusp Overlap Technique, using a dedicated checklist tool.","During the index procedure",{"measure":56,"description":57,"timeFrame":58},"Correlation of Procedural Compliance with Clinical Outcomes","Analysis of whether higher compliance with optimized TAVI procedural steps is associated with better patient outcomes.","Procedure through 1 year",{"allocation":60,"interventionModel":60,"interventionModelDescription":60,"primaryPurpose":60,"observationalModel":61,"timePerspective":62,"maskingInfo":60},null,"COHORT","PROSPECTIVE","The study population includes patients with severe, symptomatic AS with indication for TAVI, who meet the criteria for use of the Medtronic EvolutTM FX+ System in accordance with IFU and local regulations.",[65],{"label":66,"type":60,"description":67,"interventionNames":60},"Patients with severe aortic stenosis undergoing Medtronic Evolut FX+ TAVI System","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.",[69],{"name":70,"affiliation":71,"role":72},"Rui C Teles, MD, PhD","Hospital de Santa Cruz - Unidade Local de Saúde de Lisboa Ocidental","PRINCIPAL_INVESTIGATOR",[74,78],{"name":70,"role":75,"phone":76,"phoneExt":60,"email":77},"CONTACT","(+351) 210 433 069","rcteles@outlook.com",{"name":79,"role":75,"phone":60,"phoneExt":60,"email":80},"Joana D Silva, MD, PhD","secretariado.apic@spc.pt",[82,100,112,127,138,149,161,172,183,198,213,227],{"facility":83,"status":84,"city":85,"state":86,"zip":87,"country":88,"countryCode":89,"cosmosGeoPoint":90,"geoPoint":95,"contacts":96},"Hospitais da Universidade de Coimbra","RECRUITING","Coimbra","Coimbra District","3004-561","Portugal","PT",{"type":91,"coordinates":92},"Point",[93,94],-8.41996,40.20686,{"lat":94,"lon":93},[97,99],{"name":79,"role":75,"phone":60,"phoneExt":60,"email":98},"joanadelgadosilva@gmail.com",{"name":79,"role":72,"phone":60,"phoneExt":60,"email":60},{"facility":101,"status":102,"city":85,"state":86,"zip":103,"country":88,"countryCode":89,"cosmosGeoPoint":104,"geoPoint":106,"contacts":107},"Hospital da Luz Coimbra","NOT_YET_RECRUITING","3020-479",{"type":91,"coordinates":105},[93,94],{"lat":94,"lon":93},[108,111],{"name":109,"role":75,"phone":60,"phoneExt":60,"email":110},"Marco Costa, MD","marcocostacard@sapo.pt",{"name":109,"role":72,"phone":60,"phoneExt":60,"email":60},{"facility":113,"status":84,"city":114,"state":115,"zip":116,"country":88,"countryCode":89,"cosmosGeoPoint":117,"geoPoint":121,"contacts":122},"Hospital CUF Tejo","Lisbon","Lisbon District","1350-352",{"type":91,"coordinates":118},[119,120],-9.1498,38.72509,{"lat":120,"lon":119},[123,126],{"name":124,"role":75,"phone":60,"phoneExt":60,"email":125},"António Fiarresga, MD, PhD","antonio.fiarresga@jmellosaude.pt",{"name":124,"role":72,"phone":60,"phoneExt":60,"email":60},{"facility":128,"status":84,"city":114,"state":115,"zip":129,"country":88,"countryCode":89,"cosmosGeoPoint":130,"geoPoint":132,"contacts":133},"Hospital de Santa Cruz","1449-005",{"type":91,"coordinates":131},[119,120],{"lat":120,"lon":119},[134,137],{"name":135,"role":75,"phone":60,"phoneExt":60,"email":136},"João Brito, MD","jdbrito@netcabo.pt",{"name":135,"role":72,"phone":60,"phoneExt":60,"email":60},{"facility":139,"status":102,"city":114,"state":115,"zip":140,"country":88,"countryCode":89,"cosmosGeoPoint":141,"geoPoint":143,"contacts":144},"Hospital Lusíadas Lisboa","1500-458",{"type":91,"coordinates":142},[119,120],{"lat":120,"lon":119},[145,148],{"name":146,"role":75,"phone":60,"phoneExt":60,"email":147},"Eduardo I Oliveira, MD","e.infante.de.oliveira@gmail.com",{"name":146,"role":72,"phone":60,"phoneExt":60,"email":60},{"facility":150,"status":102,"city":114,"state":115,"zip":151,"country":88,"countryCode":89,"cosmosGeoPoint":152,"geoPoint":154,"contacts":155},"Hospital da Luz Lisboa","1500-650",{"type":91,"coordinates":153},[119,120],{"lat":120,"lon":119},[156,159],{"name":157,"role":75,"phone":60,"phoneExt":60,"email":158},"Pedro Gonçaves, MD, PhD","paraujogoncalves@yahoo.co.uk",{"name":160,"role":72,"phone":60,"phoneExt":60,"email":60},"Pedro Gonçalves, MD, PhD",{"facility":162,"status":84,"city":114,"state":115,"zip":163,"country":88,"countryCode":89,"cosmosGeoPoint":164,"geoPoint":166,"contacts":167},"Hospital Santa Maria","1649-035",{"type":91,"coordinates":165},[119,120],{"lat":120,"lon":119},[168,171],{"name":169,"role":75,"phone":60,"phoneExt":60,"email":170},"Pedro C Ferreira, MD","pcarrilhoferreira@gmail.com",{"name":169,"role":72,"phone":60,"phoneExt":60,"email":60},{"facility":173,"status":84,"city":114,"state":115,"zip":174,"country":88,"countryCode":89,"cosmosGeoPoint":175,"geoPoint":177,"contacts":178},"Hospital Santa Marta","2855-697",{"type":91,"coordinates":176},[119,120],{"lat":120,"lon":119},[179,182],{"name":180,"role":75,"phone":60,"phoneExt":60,"email":181},"Duarte Cacela, MD","dcacela@hotmail.com",{"name":180,"role":72,"phone":60,"phoneExt":60,"email":60},{"facility":184,"status":102,"city":185,"state":186,"zip":187,"country":88,"countryCode":89,"cosmosGeoPoint":188,"geoPoint":192,"contacts":193},"Hospital Dr. Nélio Mendonça","Funchal","Madeira","9004-514",{"type":91,"coordinates":189},[190,191],-16.92547,32.66568,{"lat":191,"lon":190},[194,197],{"name":195,"role":75,"phone":60,"phoneExt":60,"email":196},"Bruno Silva, MD","brunofranciscosilva@gmail.com",{"name":195,"role":72,"phone":60,"phoneExt":60,"email":60},{"facility":199,"status":84,"city":200,"state":201,"zip":202,"country":88,"countryCode":89,"cosmosGeoPoint":203,"geoPoint":207,"contacts":208},"Hospital Universitário de São João","Porto","Porto District","4200-319",{"type":91,"coordinates":204},[205,206],-8.61097,41.1485,{"lat":206,"lon":205},[209,212],{"name":210,"role":75,"phone":60,"phoneExt":60,"email":211},"Ricardo Lopes, MD","rjlclopes@hotmail.com",{"name":210,"role":72,"phone":60,"phoneExt":60,"email":60},{"facility":214,"status":102,"city":215,"state":215,"zip":216,"country":88,"countryCode":89,"cosmosGeoPoint":217,"geoPoint":221,"contacts":222},"Hospital Eduardo Santos Silva","Vila Nova de Gaia","4434-502",{"type":91,"coordinates":218},[219,220],-8.61241,41.12401,{"lat":220,"lon":219},[223,226],{"name":224,"role":75,"phone":60,"phoneExt":60,"email":225},"Pedro Braga, MD","jbraga@ulsge.min-saude.pt",{"name":224,"role":72,"phone":60,"phoneExt":60,"email":60},{"facility":228,"status":102,"city":229,"state":230,"zip":231,"country":88,"countryCode":89,"cosmosGeoPoint":232,"geoPoint":236,"contacts":237},"Hospital do Espírito Santo de Évora","Evora","Évora District","7000-811",{"type":91,"coordinates":233},[234,235],-7.90405,38.56587,{"lat":235,"lon":234},[238,241],{"name":239,"role":75,"phone":60,"phoneExt":60,"email":240},"Lino Patrício, MD, PhD","linopatricio@gmail.com",{"name":239,"role":72,"phone":60,"phoneExt":60,"email":60},{"type":243,"investigatorFullName":60,"investigatorTitle":60,"investigatorAffiliation":60,"oldNameTitle":60,"oldOrganization":60},"SPONSOR",[245],{"name":246,"class":247},"Medtronic","INDUSTRY","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":257,"type":258},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.",[263],"Severe Symptomatic Aortic Stenosis (Defined as New York Heart Association (NYHA) Class ≥ II)",[265,266,267,268,269,270,271,272],"TAVI","Transcatheter Aortic Valve Implantation","Evolut FX+","Aortic Stenosis","Cusp Overlap Technique","Conduction Disorders","Evolut FX+ TAVI System","TAVI System","2026-07-01",{"date":275,"type":276},"2026-07-02","ACTUAL",{"date":278,"type":276},"2026-01-14",{"date":280,"type":258},"2028-04",{"name":5,"class":6},12]