[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100594234":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":29,"centralContacts":33,"locations":39,"responsibleParty":55,"collaborators":28,"id":57,"slug":58,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":63,"eligibilityCriteria":64,"healthyVolunteers":59,"sex":65,"minAge":66,"maxAge":28,"enrollmentInfo":67,"targetDuration":28,"studyType":70,"phases":71,"briefSummary":73,"conditions":74,"keywords":79,"overallStatus":85,"whyStopped":28,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},{"fullName":5,"class":6},"Fondazione Policlinico Universitario Agostino Gemelli IRCCS","OTHER",[8,14,18],{"label":9,"type":10,"description":11,"interventionNames":12},"Balloon-expandable valve (Group A)","EXPERIMENTAL","Participants in this arm will receive a balloon-expandable transcatheter heart valve (SAPIEN platform, Edwards Lifesciences). Cerebral oxygenation will be monitored during the TAVI procedure using NIRS.",[13],"Device: Near-infrared spectroscopy monitoring (NIRS) INVOS 5100C",{"label":15,"type":10,"description":16,"interventionNames":17},"Self-expanding intra-annular valve (Group B1)","Participants in this arm will receive an intra-annular self-expanding valve (NAVITOR, Abbott). Cerebral rSO₂ will be monitored during TAVI using NIRS at predefined timepoints.",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"Self-expanding supra-annular valve (Group B2)","Participants in this arm will receive a supra-annular self-expanding valve (EVOLUT, Medtronic). NIRS will be used to monitor cerebral oxygenation throughout the TAVI procedure.",[13],[23],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"DEVICE","Near-infrared spectroscopy monitoring (NIRS) INVOS 5100C","Continuous bilateral cerebral oxygen saturation monitoring using near-infrared spectroscopy (NIRS) during TAVI. Sensors are placed on the forehead to record rSO₂ values at predefined timepoints. Device used: INVOS 5100C (Medtronic\u002FCovidien).",[9,15,19],null,[30],{"name":31,"affiliation":5,"role":32},"Cristina Aurigemma","PRINCIPAL_INVESTIGATOR",[34],{"name":35,"role":36,"phone":37,"phoneExt":28,"email":38},"Cristina Aurigemma, M.D.","CONTACT","+39 06 3015 5950","cristina.aurigemma@policlinicogemelli.it",[40],{"facility":41,"status":28,"city":42,"state":43,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"Fondazione Policlinico Universitario A. Gemelli IRCCS","Rome","Lazio","00168","Italy","IT",{"type":48,"coordinates":49},"Point",[50,51],12.51133,41.89193,{"lat":51,"lon":50},[54],{"name":35,"role":36,"phone":28,"phoneExt":28,"email":38},{"type":56,"investigatorFullName":28,"investigatorTitle":28,"investigatorAffiliation":28,"oldNameTitle":28,"oldOrganization":28},"SPONSOR","100594234","cerebral-regional-oxygen-saturation-during-tavi---the-cros-tavi-prospective-registry-100594234",false,"NCT07016789","Cerebral Regional Oxygen Saturation During TAVI - The CROS-TAVI Prospective Registry","Cerebral Regional Oxygen Saturation During TAVI: A Prospective Comparison of Balloon-Expandable and Self-Expanding Valves","CROS-TAVI","Inclusion Criteria:\n\nSigned informed consent prior to any study-specific procedures\n\nDiagnosis of severe degenerative aortic valve stenosis with echocardiographic criteria:\n\nMean gradient \\> 40 mm Hg, or\n\nJet velocity \\> 4.0 m\u002Fs, or\n\nAortic valve area (AVA) \\\u003C 0.8 cm² (or AVA index \\\u003C 0.5 cm²\u002Fm²)\n\nSymptomatic aortic stenosis defined as NYHA functional class ≥ II\n\nExclusion Criteria:\n\nSymptomatic carotid artery disease or indication for carotid revascularization\n\nCardiogenic shock or inotropic support required prior to the procedure\n\nActive neurodegenerative disease\n\nContraindications as determined by anesthesiology screening\n\nAge \\\u003C 18 years\n\nContraindications to NIRS monitoring\n\nST-elevation myocardial infarction or cardiogenic shock within 48h before enrollment\n\nEmergency TAVI due to decompensated AV stenosis\n\nMalignancy or comorbidities with life expectancy \\\u003C 12 months\n\nInability to comply with the study protocol\n\nStroke or transient ischemic attack within 6 months\n\nRenal insufficiency (creatinine \\> 3.0 mg\u002FdL) or dialysis dependency\n\nSevere left ventricular dysfunction (LVEF \\\u003C 30%)\n\nSignificant mixed valvular disease (e.g., severe mitral or tricuspid regurgitation)\n\nIntracardiac mass, thrombus, or vegetation\n\nChronic corticosteroid use\n\nParticipation in another investigational drug or device study\n\nActive bacterial endocarditis or other active infections","ALL","18 Years",{"count":68,"type":69},40,"ESTIMATED","INTERVENTIONAL",[72],"NA","This single-center, non-commercial clinical study investigates how different types of transcatheter aortic valve prostheses affect cerebral oxygen saturation during the procedure (TAVI - Transcatheter Aortic Valve Implantation). The study uses a non-invasive monitoring system (NIRS) to track brain oxygenation (rSO₂) in real time.\n\nThe goal is to understand whether balloon-expandable, intra-annular self-expanding, or supra-annular self-expanding valves lead to different levels or patterns of cerebral oxygenation. This may help identify early warning signs for delayed hemodynamic recovery, stroke, or delirium.\n\nParticipants will be randomly assigned to receive one of:\n\nA balloon-expandable valve (Group A), or\n\nA self-expanding valve (Group B), with further randomization into:\n\nGroup B1: intra-annular valve (NAVITOR)\n\nGroup B2: supra-annular valve (EVOLUT)\n\nThe procedure, follow-up, and data collection will follow standard clinical practice. No experimental devices or drugs are used. Patients will not undergo any additional risk or burden beyond what is normally expected during TAVI.\n\nThe study is being conducted at the Fondazione Policlinico Universitario A. Gemelli IRCCS in Rome, Italy, and aims to enroll 40 patients. No compensation is provided, and participation is voluntary.",[75,76,77,78],"Aortic Stenosis Disease","TAVI(Transcatheter Aortic Valve Implantation)","Cerebral Oxygen Saturation","Hemodynamic Changes",[80,81,77,82,83,84],"TAVI","Aortic Valve Stenosis","NIRS","Balloon-Expandable Valve","Self-Expanding Valve","NOT_YET_RECRUITING","2025-06-23",{"date":88,"type":89},"2025-06-26","ACTUAL",{"date":91,"type":69},"2025-06",{"date":93,"type":69},"2026-06",{"name":5,"class":6},1]