[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100582126":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":31,"responsibleParty":75,"collaborators":20,"id":77,"slug":78,"hasResults":79,"nctId":80,"briefTitle":81,"officialTitle":81,"acronym":82,"eligibilityCriteria":83,"healthyVolunteers":79,"sex":84,"minAge":20,"maxAge":20,"enrollmentInfo":85,"targetDuration":20,"studyType":88,"phases":89,"briefSummary":91,"conditions":92,"keywords":94,"overallStatus":34,"whyStopped":20,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":113},{"fullName":5,"class":6},"IRCCS Policlinico S. Donato","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Aortic Valve Replacement Patient","EXPERIMENTAL","Inclusion criteria:\n\n* evaluation of patients who underwent SAVR or TAVI for severe aortic stenosis\n* implanted with valve models and sizes among those which we evaluated in vitro.\n\nExclusion criteria:\n\n* treated or untreated aortic root\u002Fascending aorta aneurysm\n* preoperative aortic regurgitation more than moderate\n* recent (\\\u003C12 weeks)\u002F concomitant revascularization or recent (\\\u003C12 weeks) ACS\n\nTiming of trans-thoracic echocardiography (TTE) and MRI: 1 to 3 months after SAVR\u002FTAVR.\n\nIntervention: MRI, it is not clinical practice during 1 month follow-up. Clinical Variables: in order to reduce clinical bias in the comparison of the two populations, at the moment of TTE exam, blood pressure, heart rate and haemoglobin values will be recorded.",[13],"Diagnostic Test: MRI",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DIAGNOSTIC_TEST","MRI","The patients will be undergo to a MRI without contrast after 1 month from the procedure\u002Fsurgery to test the hwmodynamic performance 4d flow in the implanted valve",[9],null,[22,27],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},"Agnese Rossi, Study Coordinator","CONTACT","00393409009040","agnese.rossi@grupposandonato.it",{"name":28,"role":24,"phone":29,"phoneExt":20,"email":30},"Giacomo Bortolussi, Researcher - Cardiac Surgeon","003900393246943755","giacomo.bortolussi@grupposandonato.it",[32,56],{"facility":33,"status":34,"city":35,"state":36,"zip":37,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":46},"Policlinico di Bari","RECRUITING","Bari","Apulia","70100","Italy","IT",{"type":41,"coordinates":42},"Point",[43,44],16.86982,41.12066,{"lat":44,"lon":43},[47,51,53],{"name":48,"role":24,"phone":49,"phoneExt":20,"email":50},"Nicola Vitale, Researcher - Cardiac Surgeon","00393333571980","nicolavitale8@gmail.com",{"name":52,"role":24,"phone":20,"phoneExt":20,"email":20},"Tomaso Bottio, Researcher -Cardiac Surgeon",{"name":54,"role":55,"phone":20,"phoneExt":20,"email":20},"Nicola Vitale, Researcher-Cardiac Surgeon","PRINCIPAL_INVESTIGATOR",{"facility":57,"status":34,"city":58,"state":59,"zip":60,"country":38,"countryCode":39,"cosmosGeoPoint":61,"geoPoint":65,"contacts":66},"IRCCS Policlinico San Donato","San Donato","Lombardy","20097",{"type":41,"coordinates":62},[63,64],9.67506,45.30507,{"lat":64,"lon":63},[67,70,73],{"name":68,"role":24,"phone":69,"phoneExt":20,"email":26},"Agnese Rossi, Study coordinator","3409009040",{"name":71,"role":24,"phone":72,"phoneExt":20,"email":30},"Giacomo Bortolussi, Researcher Cardiac Surgeon","00393246943755",{"name":74,"role":55,"phone":20,"phoneExt":20,"email":20},"Alessandro Parolari, PI- Cardiac Surgeon",{"type":76,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100582126","in-vitro-benchmarking-of-currently-available-heart-valve-prostheses-for-surgical-and-percutaneous-treatment-of-aortic-stenosis-with-small-annulus-followed-by-in-vivo-validation-100582126",false,"NCT06859255","In-vitro Benchmarking of Currently Available Heart Valve Prostheses for Surgical and Percutaneous Treatment of Aortic Stenosis With Small Annulus, Followed by In-vivo Validation","SurPASS","Inclusion Criteria:\n\n* patients who underwent SAVR or TAVI for severe aortic stenosis\n* implanted with valve models and sizes among those which we evaluated in vitro\n\nExclusion Criteria:\n\n* treated or untreated aortic root\u002Fascending aorta aneurysm\n* preoperative aortic regurgitation more than moderate\n* recent (\\\u003C12 weeks)\u002F concomitant revascularization\n* recent (\\\u003C12 weeks) ACS\n* PPI (permanent pacemaker implantation)\n* other than sinus rythm\n* Paravalvular leak (PVL) \\> moderate.","ALL",{"count":86,"type":87},200,"ESTIMATED","INTERVENTIONAL",[90],"NA","The general objective of this study is to compare in vitro and in vivo the hemodynamic performance of different types of aortic valve prostheses and possible surgical implantation techniques.\n\nThe study involves the collection of data deriving from tests and procedures foreseen by normal clinical practice, including a transthoracic color Doppler echocardiogram, to which is added a 4DFlow cardiac MRI (magnetic resonance imaging) without contrast medium, to be performed between 1 and 3 months after the operation.\n\nThe study will last 24 months and the patients involvement will end approximately 1-3 months after the intervention.\n\nThere are no direct benefits expected from participation in the study. However, the instrumental data obtained by echocardiogram and Magnetic Resonance Imaging will be useful for monitoring the medium-term surgical outcome of patients after surgery.",[93],"Severe Aortic Valve Stenosis",[95,96,97,98,99,100,101,102,103],"aortic valve stenosis","valve replacement","TAVI","hemodynamic","4d flow","cardiac echo","cardiac RMN","aortic valve","TAVR","2026-07-01",{"date":106,"type":107},"2026-07-02","ACTUAL",{"date":109,"type":107},"2025-02-07",{"date":111,"type":87},"2027-02-07",{"name":5,"class":6},2]