[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100627950":3},{"organization":4,"armGroups":7,"interventions":13,"overallOfficials":24,"centralContacts":28,"locations":38,"responsibleParty":78,"collaborators":32,"id":80,"slug":81,"hasResults":82,"nctId":83,"briefTitle":84,"officialTitle":84,"acronym":85,"eligibilityCriteria":86,"healthyVolunteers":82,"sex":87,"minAge":88,"maxAge":32,"enrollmentInfo":89,"targetDuration":32,"studyType":92,"phases":93,"briefSummary":95,"conditions":96,"keywords":100,"overallStatus":41,"whyStopped":32,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":110},{"fullName":5,"class":6},"IRCCS Policlinico S. Donato","OTHER",[8],{"label":9,"type":6,"description":10,"interventionNames":11},"TRANSLATE Study Population","The retrospective phase includes adult patients who previously underwent clinically indicated cardiac MRI for left ventricular functional assessment. The prospective phase includes patients with severe aortic stenosis undergoing transcatheter aortic valve replacement, who undergo additional non-contrast 4D Flow MRI and standard invasive hemodynamic measurements as part of routine clinical care. Data from both phases are used for development and validation of automated MRI-based analysis methods.",[12],"Diagnostic Test: Cardiac MRI with 4D Flow acquisition and invasive signal routinely collected during transcatheter aortic valve replacement",[14],{"type":15,"name":16,"description":17,"armGroupLabels":18,"otherNames":19},"DIAGNOSTIC_TEST","Cardiac MRI with 4D Flow acquisition and invasive signal routinely collected during transcatheter aortic valve replacement","Cardiac magnetic resonance imaging, including standard cine imaging and non-contrast 4D Flow MRI acquisition. In the prospective phase, invasive and non-invasive hemodynamic signals routinely collected during the transcatheter aortic valve replacement procedure are recorded for research analysis. No additional procedures beyond standard clinical practice are required.\n\nThis is a low-intervention interventional study in which all imaging acquisitions and hemodynamic measurements are performed according to standard clinical practice, with no modification of diagnostic or therapeutic pathways.",[9],[20,21,22,23],"transcatheter aortic valve implantation","4D Flow MRI","intracardic invasive pressure","non-invasive blood pressure",[25],{"name":26,"affiliation":5,"role":27},"Giandomenico Disabato, MD","PRINCIPAL_INVESTIGATOR",[29,34],{"name":26,"role":30,"phone":31,"phoneExt":32,"email":33},"CONTACT","+390252774804",null,"giandomenico.disabato@grupposandonato.it",{"name":35,"role":30,"phone":36,"phoneExt":32,"email":37},"Francesco Sturla, PhD","+390252774353","francesco.sturla@grupposandonato.it",[39,66],{"facility":40,"status":41,"city":42,"state":32,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"IRCCS Policlinico San Donato","RECRUITING","San Donato Milanese","20097","Italy","IT",{"type":47,"coordinates":48},"Point",[49,50],9.26838,45.41047,{"lat":50,"lon":49},[53,54,55,56,59,60,62,64],{"name":26,"role":30,"phone":31,"phoneExt":32,"email":33},{"name":35,"role":30,"phone":36,"phoneExt":32,"email":37},{"name":26,"role":27,"phone":32,"phoneExt":32,"email":32},{"name":57,"role":58,"phone":32,"phoneExt":32,"email":32},"Riccardo Gorla, MD, PhD","SUB_INVESTIGATOR",{"name":35,"role":58,"phone":32,"phoneExt":32,"email":32},{"name":61,"role":58,"phone":32,"phoneExt":32,"email":32},"Massimo Lombardi, MD",{"name":63,"role":58,"phone":32,"phoneExt":32,"email":32},"Francesco Bedogni, MD",{"name":65,"role":58,"phone":32,"phoneExt":32,"email":32},"Sofia Di Filippo, MSc",{"facility":40,"status":41,"city":42,"state":32,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":67,"geoPoint":69,"contacts":70},{"type":47,"coordinates":68},[49,50],{"lat":50,"lon":49},[71,73,75,76,77],{"name":72,"role":30,"phone":36,"phoneExt":32,"email":37},"Francesco Sturla, MD",{"name":74,"role":58,"phone":32,"phoneExt":32,"email":32},"Riccardo Gorla, PhD",{"name":63,"role":58,"phone":32,"phoneExt":32,"email":32},{"name":61,"role":58,"phone":32,"phoneExt":32,"email":32},{"name":65,"role":58,"phone":32,"phoneExt":32,"email":32},{"type":79,"investigatorFullName":32,"investigatorTitle":32,"investigatorAffiliation":32,"oldNameTitle":32,"oldOrganization":32},"SPONSOR","100627950","phenotyping-left-ventricle-failure-with-hemodynamic-biomarkers-from-4d-flow-magnetic-resonance-imaging-100627950",false,"NCT07455292","Phenotyping Left Ventricle Failure With Hemodynamic Biomarkers From 4D Flow Magnetic Resonance Imaging","TRANSLATE","Inclusion Criteria:\n\n* Adult patients (age \\> 18 years old);\n* Diagnosis of severe AS defined according to ESC guidelines with indication to TAVR;\n* Severe aortic stenosis both in normal\u002Fhigh flow status and in low flow status;\n* Signed informed written consent.\n\nExclusion Criteria:\n\n* Contraindication to cardiac MRI due to previous implant with ferromagnetic components;\n* Poor MRI quality impairing image post-processing;\n* Claustrophobia;\n* Unwilling to sign the informed consent.","ALL","18 Years",{"count":90,"type":91},190,"ESTIMATED","INTERVENTIONAL",[94],"NA","This study aims to enhance and streamline intracardiac 4D Flow magnetic resonance imaging (MRI) processing by increasing automation for the quantitative and systematic assessment of left ventricular (LV) dysfunction. The study is designed to achieve the following three objectives.\n\nThe primary objective is to develop a convolutional neural network (CNN)-based deep learning model for the automatic segmentation of the LV endocardial contour throughout the cardiac cycle using intracavitary MRI data. To support model training, a dataset of LV endocardial wall segmentations will be generated from balanced steady-state free precession (bSSFP) images. A purpose-built retrospective MRI database of bSSFP images will be retrieved to accelerate training set creation.\n\nThe secondary objective is to develop a numerical framework for non-invasive MRI-based pressure-volume (PV) loop reconstruction and calculation of simplified hemodynamic force descriptors (HDFs). A prospective cohort of patients with severe aortic stenosis undergoing transcatheter aortic valve replacement (TAVR) will be enrolled. Pre-procedural non-contrast 4D Flow MRI will be acquired, and non-invasive MRI-derived PV loops will be quantitatively compared with invasive catheter-based PV loop measurements. In addition, simplified HDFs will be compared with 4D Flow-derived HDFs to assess their agreement and their potential to elucidate specific features of heart failure-related LV dysfunction.\n\nThe tertiary objective is to establish the foundation for a unified, standalone, and clinically deployable framework for comprehensive, automated, and clinician-friendly analysis of LV hemodynamics based on 4D Flow MRI. Internal testing, benchmarking, and structured evaluation by clinical end-users with prior 4D Flow MRI research experience will be conducted to collect feedback and guide further development and clinical translation.",[97,98,99],"Left Ventricle Function","Transcatheter Aortic Valve Replacement (TAVR)","Aortic Valve Stenosis",[21],"2026-03-02",{"date":103,"type":104},"2026-03-06","ACTUAL",{"date":106,"type":104},"2025-10-13",{"date":108,"type":91},"2026-09-30",{"name":5,"class":6},2]