[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100383674":3},{"organization":4,"outcomesModule":7,"designInfo":109,"detailedDescription":116,"studyPopulation":108,"armGroups":117,"interventions":138,"overallOfficials":150,"centralContacts":159,"locations":165,"responsibleParty":937,"collaborators":108,"id":939,"slug":940,"hasResults":941,"nctId":942,"briefTitle":943,"officialTitle":944,"acronym":945,"eligibilityCriteria":946,"healthyVolunteers":941,"sex":947,"minAge":948,"maxAge":108,"enrollmentInfo":949,"targetDuration":108,"studyType":952,"phases":953,"briefSummary":955,"conditions":956,"keywords":958,"overallStatus":185,"whyStopped":108,"lastUpdateSubmitDate":962,"lastUpdatePostDateStruct":963,"startDateStruct":966,"completionDateStruct":968,"leadSponsor":970,"locationsCount":971},{"fullName":5,"class":6},"Meril Life Sciences Pvt. Ltd.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":108},[9],{"measure":10,"description":11,"timeFrame":12},"Primary Combined Safety and Effectiveness Endpoint as defined by the Valve Academic Research Consortium-3 (VARC-3)","It is the composite of following:\n\n* All-cause mortality\n* All stroke\n* Bleeding (Type 3 and 4)\n* Acute kidney injury (AKI) (Stage 2, 3 and 4)\n* Major vascular complications\n* Moderate or severe prosthetic valve regurgitation\n* Conduction system disturbances resulting in a new PPI","30-day",[14,18,22,25,28,30,33,37,39,42,44,47,50,52,54,58,62,64,67,71,74,78,81,84,86,88,90,93,96,99,101,104,106],{"measure":15,"description":16,"timeFrame":17},"The combined safety and effectiveness endpoint as defined by the Valve Academic Research Consortium-3 (VARC-3)","It is the composite of following:\n\n* All-cause mortality\n* All stroke\n* Bleeding (Type 3 and 4)\n* AKI (Stage 2, 3 and 4)\n* Major vascular complications\n* Moderate or severe prosthetic valve regurgitation\n* Conduction system disturbances resulting in a new PPI","1-year",{"measure":19,"description":20,"timeFrame":21},"All-cause mortality","As per VARC-3 defined criteria","Pre-discharge, 30-day, 6-month, 1-year, 2-year, 3-year, 4 year, 5-year, 7-year, and 10-year",{"measure":23,"description":20,"timeFrame":24},"All stroke","Pre-discharge, 30-day, 1-year, 3-year, and 5-year",{"measure":26,"description":20,"timeFrame":27},"Acute Kidney Injury (AKI) (Stage 2, 3 and 4)","Pre-discharge, 30-day, and 1-year",{"measure":29,"description":20,"timeFrame":24},"Bleeding (Type 3 and 4)",{"measure":31,"description":20,"timeFrame":32},"Moderate or severe prosthetic valve regurgitation","Pre-discharge, 30-day, 1-year, 3-year, 5-year, 7-year, and 10-year",{"measure":34,"description":35,"timeFrame":36},"New permanent pacemaker implantation (As per VARC-3 defined criteria)","o New PPI rates will be analysed further based on the patient's history of left and\u002For right bundle branch block.","Pre-discharge, 30-day, 6-month, 1-year, 2-year, 3-year, 4-year, 5-year, 7-year, and 10-year",{"measure":38,"description":20,"timeFrame":24},"Conduction disturbances and arrhythmias",{"measure":40,"description":20,"timeFrame":41},"Device success","Pre-discharge and 30-day",{"measure":43,"description":20,"timeFrame":12},"Early safety at 30 days",{"measure":45,"description":20,"timeFrame":46},"Clinical efficacy at 30 days","After 30 days of index procedure",{"measure":48,"description":20,"timeFrame":49},"Valve related long-term clinical efficacy","5-years, 7 years and 10 years",{"measure":51,"description":20,"timeFrame":27},"Vascular and access related complications",{"measure":53,"description":20,"timeFrame":27},"Major vascular complications",{"measure":55,"description":56,"timeFrame":57},"Functional improvement from baseline as measured per","New York Heart Association (NYHA) functional classification \\[Time frame: Baseline (pre-procedure), 30-day, 1-year, 3-year, 5-year, 7-year, and 10-year\\] Six-minute walk test \\[Time frame: Baseline (pre-procedure), 30-day and 1-year\\]","[Time frame: Baseline (pre-procedure), 30-day, 1-year, 3-year, 5-year, 7-year, and 10-year], [Time frame: Baseline (pre-procedure), 30-day and 1-year]",{"measure":59,"description":60,"timeFrame":61},"Echocardiographic endpoints","* Effective orifice area (EOA)\n* Index effective orifice area (iEOA)\n* Mean aortic valve gradient\n* Peak aortic valve gradient\n* Peak aortic velocity\n* Total aortic regurgitation, transvalvular regurgitation (except baseline) and paravalvular regurgitation (except baseline)\n* Left ventricular ejection fraction (LVEF)\n* Valve calcification\n* Cardiac output and cardiac index","Baseline, pre-discharge, 30-day, 1-year, 3-year, 5-year, 7-year, and 10-year",{"measure":63,"description":20,"timeFrame":24},"Bioprosthetic valve deterioration",{"measure":65,"description":66,"timeFrame":27},"Patient-prosthesis mismatch","Severity patient-prosthesis-mismatch will be based on following\n\n* For subjects with body mass index (BMI) \\\u003C30 kg\u002Fm2, EOAi: 0.85 - 0.66 cm2 \u002Fm2 considered as moderate and ≤0.65 cm2 \u002Fm2 considered as severe\n* For subjects with BMI ≥30 kg\u002Fm2, EOAi: 0.70 - 0.56 cm2 \u002Fm2 considered as moderate and ≤0.55 cm2 \u002Fm2 considered as severe\n* BMI = weight(kg)\u002F(height (m))2",{"measure":68,"description":69,"timeFrame":70},"Length of index hospital stay","o Number of days from hospital admission to discharge.","At discharge",{"measure":72,"description":20,"timeFrame":73},"Re-hospitalization","30-day, 1-year, 3-year, and 5-year",{"measure":75,"description":76,"timeFrame":77},"Health status as evaluated by Quality of Life questionnaires","o 12-Item Short Form Survey (SF-12)","Baseline (pre-procedure), 30-day, and 1-year",{"measure":79,"description":80,"timeFrame":73},"Valve thrombosis","o Valve thrombosis as per VARC-2 is any thrombus attached to or near an implanted valve that occludes part of the blood flow path, interferes with valve function, or is sufficiently large to warrant treatment. Note that valve-associated thrombus identified at autopsy in a patient whose cause of death was not valve-related should not be reported as valve thrombosis.",{"measure":82,"description":20,"timeFrame":83},"Coronary obstruction requiring intervention","Pre-discharge",{"measure":85,"description":20,"timeFrame":83},"Valve malpositioning",{"measure":87,"description":20,"timeFrame":83},"Conversion to open surgery",{"measure":89,"description":20,"timeFrame":83},"Unplanned use of mechanical circulatory support (cardiopulmonary bypass (CPB), extracorporeal membrane oxygenation (ECMO), transcatheter pumps or intra-aortic balloon pump (IABP)",{"measure":91,"description":20,"timeFrame":92},"Implantation of multiple (>1) transcatheter valves during the index hospitalization","Index-procedure",{"measure":94,"description":20,"timeFrame":95},"Cardiac structural complications","30 days, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years",{"measure":97,"description":98,"timeFrame":83},"Ventricular septal perforation","o Angiographic or echocardiographic evidence of a new septal perforation during or after the TAVI procedure",{"measure":100,"description":20,"timeFrame":24},"New onset of atrial fibrillation or atrial flutter",{"measure":102,"description":20,"timeFrame":103},"Technical success","Post-procedure",{"measure":105,"description":20,"timeFrame":24},"Myocardial Infarction",{"measure":107,"description":20,"timeFrame":73},"Endocarditis",null,{"allocation":110,"interventionModel":111,"interventionModelDescription":112,"primaryPurpose":113,"observationalModel":108,"timePerspective":108,"maskingInfo":114},"RANDOMIZED","PARALLEL","The randomisation will be carried out with an allocation ratio of 1:1 between Myval THV Series vs. Contemporary Valves (Sapien THV Series and Evolut THV Series).","TREATMENT",{"masking":115,"maskingDescription":108,"whoMasked":108},"NONE","LANDMARK Trial is a prospective, randomised, multinational, multicentric, open-label non-inferiority trial of total 768 subjects (384:384, Myval THV Series vs. Contemporary Valves) with severe symptomatic native aortic valve stenosis via transfemoral approach.\n\n* Device sizes applicable for the Myval THV Series: 20 mm, 21.5 mm, 23 mm, 24.5 mm, 26 mm, 27.5 mm, and 29 mm diameter.\n* Device sizes applicable for the Sapien 3 THV Series: 20 mm, 23 mm, 26 mm, and 29 mm diameter.\n* Device sizes applicable for the Evolut THV Series: 23 mm, 26 mm, 29 mm, and 34 mm diameter.\n\nA non-randomised nested registry will be conducted to include patients requiring extra-large size of Myval THV series (XL Nested Registry)\n\n\\- Device sizes applicable for the XL Nested Registry: 30.5 mm and 32 mm.\n\nA non-randomized registry will include patients implanted with the Myval THV Series (Lead-in Set).\n\n\\- The investigators have to perform a minimum of 2 lead-in cases (non-randomised) under the guidance of the lead-in evaluation committee.",[118,124,130,134],{"label":119,"type":120,"description":121,"interventionNames":122},"Myval THV Series","EXPERIMENTAL","Myval THV Series will include Myval\u002FMyval Inception THVs or any subsequent advanced version commercially available at the study site.\n\nThis treatment arm will be assigned to 384 \u002F 768 subjects enrolled in a study.",[123],"Device: Myval THV Series",{"label":125,"type":126,"description":127,"interventionNames":128},"Contemporary Valves","ACTIVE_COMPARATOR","* Sapien THV Series will consist of Sapien 3\u002FSapien 3 Ultra THVs or any subsequent advanced version commercially available at the study site.\n* Evolut THV Series will include Evolut R\u002FEvolut PRO THVs or any subsequent advanced version commercially available at the study site.\n\nThis treatment arm will be assigned to 384 \u002F 768 subjects enrolled in a study.",[129],"Device: Contemporary Valves (Sapien THV Series and Evolut THV Series)",{"label":131,"type":120,"description":132,"interventionNames":133},"Myval THV Series XL Nested Registry","A non-randomised, nested registry of patients with anatomy of native aortic annulus suitable to be implanted with extra-large size of Myval THV series (30.5mm or 32mm) as per Heart Team assessment\u002FInvestigator's discretion is designed. The objective of this registry is to assess the safety and effectiveness of extra-large sizes of Myval THV series. Approximately 100 patients will be recruited from approximately 30 participating centres in LANDMARK Trial",[123],{"label":135,"type":120,"description":136,"interventionNames":137},"Myval THV Series Lead-in Set","The Lead-in Set aims to ensure investigators adhere to protocol requirements related to the Myval THV Series device, including imaging and procedural guidelines. Investigators should be independent before enrolling study subjects, allowing for valuable feedback for initial safety assessments. Each investigator must conduct at least two non-randomized lead-in cases under the guidance of an evaluation committee. Lead-in subjects will only receive the study device, and if implantation fails, standard care will be provided. These subjects will not be included in primary or secondary endpoint analyses but will undergo descriptive analysis. Unique numbers will be assigned to all lead-in subjects, and the committee will evaluate outcomes and site independence for future trial recruitment.",[123],[139,145],{"type":140,"name":119,"description":141,"armGroupLabels":142,"otherNames":143},"DEVICE","The devices in the study are intended to improve aortic valve function for patients with severe symptomatic native aortic valve stenosis who are eligible for TAVR therapy. Every patient must be deemed treatable with an available size of both the test and contemporary heart valves approved for use and commercially available at the investigational centre where the implant procedure is being performed.",[119,135,131],[144],"Myval\u002FMyval Inception THVs or any subsequent advanced version commercially available at the study site.",{"type":140,"name":146,"description":141,"armGroupLabels":147,"otherNames":148},"Contemporary Valves (Sapien THV Series and Evolut THV Series)",[125],[149],"Sapien THV Series (Sapien 3\u002FSapien 3 Ultra THVs) and Evolut THV Series (Evolut R\u002FEvolut PRO THVs ) or any subsequent advanced version commercially available at the study site.",[151,155],{"name":152,"affiliation":153,"role":154},"Andreas Baumbach, MD,FESC,FRCP","Barts Heart Center, London, UK","STUDY_CHAIR",{"name":156,"affiliation":157,"role":158},"Patrick W. Serruys, MD,PhD,FACC,FESC","National University of Ireland, Galway, Ireland","STUDY_DIRECTOR",[160],{"name":161,"role":162,"phone":163,"phoneExt":108,"email":164},"Ashok Thakkar, PhD","CONTACT","+91-9879443584","ashok.thakkar@merillife.com",[166,183,204,219,233,246,261,274,287,300,313,330,345,358,368,381,394,409,425,437,451,469,484,497,511,526,537,549,563,580,594,604,613,627,641,654,671,686,707,721,735,749,765,778,789,802,818,834,853,868,881,895,911,925],{"facility":167,"status":168,"city":169,"state":108,"zip":170,"country":171,"countryCode":172,"cosmosGeoPoint":173,"geoPoint":178,"contacts":179},"Republican Scientific-Practical Centre \"Cardiology\"","NOT_YET_RECRUITING","Minsk","220036","Belarus","BY",{"type":174,"coordinates":175},"Point",[176,177],27.56653,53.90019,{"lat":177,"lon":176},[180],{"name":181,"role":162,"phone":108,"phoneExt":108,"email":182},"Dr. Oleg Polonetsky, MD, PhD","polonetsky@yandex.ru",{"facility":184,"status":185,"city":186,"state":108,"zip":187,"country":188,"countryCode":189,"cosmosGeoPoint":190,"geoPoint":194,"contacts":195},"Hospital Dante Pazanesse","RECRUITING","São Paulo","04012-909","Brazil","BR",{"type":174,"coordinates":191},[192,193],-46.63611,-23.5475,{"lat":193,"lon":192},[196,199,202],{"name":197,"role":162,"phone":108,"phoneExt":108,"email":198},"Dr. Fausto Feres","fferes@dantepazzanese.org.br",{"name":200,"role":201,"phone":108,"phoneExt":108,"email":108},"Andrea Vilela,","SUB_INVESTIGATOR",{"name":203,"role":201,"phone":108,"phoneExt":108,"email":108},"Dimytri Siqueira",{"facility":205,"status":185,"city":206,"state":108,"zip":207,"country":208,"countryCode":209,"cosmosGeoPoint":210,"geoPoint":214,"contacts":215},"Split Clinical Hospital Center","Split","21000","Croatia","HR",{"type":174,"coordinates":211},[212,213],16.43915,43.50891,{"lat":213,"lon":212},[216],{"name":217,"role":162,"phone":108,"phoneExt":108,"email":218},"Dr. Ivica Kristic, MD, PhD","kristicivica@gmail.com",{"facility":220,"status":185,"city":221,"state":108,"zip":222,"country":208,"countryCode":209,"cosmosGeoPoint":223,"geoPoint":227,"contacts":228},"University Hospital Dubrava Avenija Gojka Šuška 6","Zagreb","10000",{"type":174,"coordinates":224},[225,226],15.97798,45.81444,{"lat":226,"lon":225},[229],{"name":230,"role":162,"phone":231,"phoneExt":108,"email":232},"Dr. Daniel Unić, MD","+385989196621","unic@kbd.hr",{"facility":234,"status":185,"city":235,"state":108,"zip":108,"country":236,"countryCode":237,"cosmosGeoPoint":238,"geoPoint":242,"contacts":243},"North Estonia Medical Center","Tallinn","Estonia","EE",{"type":174,"coordinates":239},[240,241],24.75353,59.43696,{"lat":241,"lon":240},[244],{"name":245,"role":162,"phone":108,"phoneExt":108,"email":108},"Dr. Peep Laanmets",{"facility":247,"status":185,"city":248,"state":108,"zip":249,"country":250,"countryCode":251,"cosmosGeoPoint":252,"geoPoint":256,"contacts":257},"Hôpital Henri Mondor","Créteil","94000","France","FR",{"type":174,"coordinates":253},[254,255],2.46569,48.79266,{"lat":255,"lon":254},[258],{"name":259,"role":162,"phone":108,"phoneExt":108,"email":260},"Prof. Emmanuel Teiger","emmanuel.teiger@aphp.fr",{"facility":262,"status":185,"city":263,"state":108,"zip":264,"country":250,"countryCode":251,"cosmosGeoPoint":265,"geoPoint":269,"contacts":270},"Lille University","Lille","59000",{"type":174,"coordinates":266},[267,268],3.05512,50.63391,{"lat":268,"lon":267},[271],{"name":272,"role":162,"phone":108,"phoneExt":108,"email":273},"Prof. Eric Van Belle","ericvanbelle@aol.com",{"facility":275,"status":185,"city":276,"state":108,"zip":277,"country":250,"countryCode":251,"cosmosGeoPoint":278,"geoPoint":282,"contacts":283},"Institut Cardiovascular Paris-Sud","Massy","91300",{"type":174,"coordinates":279},[280,281],2.28301,48.72692,{"lat":281,"lon":280},[284],{"name":285,"role":162,"phone":108,"phoneExt":108,"email":286},"Dr. Bernard Chevalier","bchevali@aol.com",{"facility":288,"status":185,"city":289,"state":108,"zip":290,"country":250,"countryCode":251,"cosmosGeoPoint":291,"geoPoint":295,"contacts":296},"Arnault Tzanck Institute","Nice","06200",{"type":174,"coordinates":292},[293,294],7.26608,43.70313,{"lat":294,"lon":293},[297],{"name":298,"role":162,"phone":108,"phoneExt":108,"email":299},"Dr. ADJEDJ Julien","juliendjdj@gmail.com",{"facility":301,"status":168,"city":302,"state":108,"zip":303,"country":250,"countryCode":251,"cosmosGeoPoint":304,"geoPoint":308,"contacts":309},"Centre Hospitalier Universitaire De Rennes","Rennes","35033",{"type":174,"coordinates":305},[306,307],-1.67431,48.11109,{"lat":307,"lon":306},[310],{"name":311,"role":162,"phone":108,"phoneExt":108,"email":312},"Dr. Vincent Auffret","vincent.auffret@chu-rennes.fr",{"facility":314,"status":185,"city":315,"state":316,"zip":317,"country":318,"countryCode":319,"cosmosGeoPoint":320,"geoPoint":324,"contacts":325},"Kerckhoff-KlinikForschungs GmbH","Bad Nauheim","Hesse","61231","Germany","DE",{"type":174,"coordinates":321},[322,323],8.73859,50.36463,{"lat":323,"lon":322},[326],{"name":327,"role":162,"phone":328,"phoneExt":108,"email":329},"Dr. Won K Kim, M.D","+49 60326152","w.kim@kerckhoff-klinik.de",{"facility":331,"status":185,"city":332,"state":333,"zip":334,"country":318,"countryCode":319,"cosmosGeoPoint":335,"geoPoint":339,"contacts":340},"Leipzig Heart Institute GmbH","Leipzig","Saxony","04289",{"type":174,"coordinates":336},[337,338],12.37129,51.33962,{"lat":338,"lon":337},[341],{"name":342,"role":162,"phone":343,"phoneExt":108,"email":344},"Prof Mohamed A Wahab, Ph. D","+493418650","mohamed.abdel-wahab@medizin.uni-leipzig.de",{"facility":346,"status":185,"city":347,"state":108,"zip":348,"country":318,"countryCode":319,"cosmosGeoPoint":349,"geoPoint":353,"contacts":354},"University Herzentrum Division of Cardiology and Angiology II,University Heart Center Freiburg, Südring 15","Bad Krozingen","79189",{"type":174,"coordinates":350},[351,352],7.7,47.91667,{"lat":352,"lon":351},[355],{"name":356,"role":162,"phone":108,"phoneExt":108,"email":357},"Dr. Jurgen Rothe","juergen.rothe@uniklinik-freiburg.de",{"facility":359,"status":360,"city":361,"state":108,"zip":362,"country":318,"countryCode":319,"cosmosGeoPoint":363,"geoPoint":367,"contacts":108},"Klinikum Braunschweig Freisestre","ACTIVE_NOT_RECRUITING","Braunschweig","38118",{"type":174,"coordinates":364},[365,366],10.52673,52.26594,{"lat":366,"lon":365},{"facility":369,"status":185,"city":370,"state":108,"zip":371,"country":318,"countryCode":319,"cosmosGeoPoint":372,"geoPoint":376,"contacts":377},"Technology University Dresden Fetscherstraße 76","Dresden","01307",{"type":174,"coordinates":373},[374,375],13.73832,51.05089,{"lat":375,"lon":374},[378],{"name":379,"role":162,"phone":108,"phoneExt":108,"email":380},"Prof. Dr. Axel Linke","Axel.Linke@herzzentrum-dresden.com",{"facility":382,"status":168,"city":383,"state":108,"zip":384,"country":318,"countryCode":319,"cosmosGeoPoint":385,"geoPoint":389,"contacts":390},"Asklepios Kliniken Hamburg Gmbh Lohmuehlenstrasse 5","Hamburg","20099",{"type":174,"coordinates":386},[387,388],9.99302,53.55073,{"lat":388,"lon":387},[391],{"name":392,"role":162,"phone":108,"phoneExt":108,"email":393},"Dr. Samer Hakmi, MD","samer@hakmi.des.hakmi@asklepois.com",{"facility":395,"status":185,"city":396,"state":108,"zip":397,"country":318,"countryCode":319,"cosmosGeoPoint":398,"geoPoint":402,"contacts":403},"Klinik für Herz-, Thorax- und herznahe Gefäßchirurgie, Universitätsklinikum Regensburg","Regensburg","93053",{"type":174,"coordinates":399},[400,401],12.10161,49.01513,{"lat":401,"lon":400},[404,407],{"name":405,"role":162,"phone":108,"phoneExt":108,"email":406},"Dr. med. Andreas Holzamer","andreas.holzamer@klinik.uni-regensburg.de",{"name":408,"role":201,"phone":108,"phoneExt":108,"email":108},"Prof. Dr. Med. Michael Hilker",{"facility":410,"status":185,"city":411,"state":108,"zip":412,"country":413,"countryCode":414,"cosmosGeoPoint":415,"geoPoint":419,"contacts":420},"Hippkration Hospital","Athens","11527","Greece","GR",{"type":174,"coordinates":416},[417,418],23.72784,37.98376,{"lat":418,"lon":417},[421],{"name":422,"role":162,"phone":423,"phoneExt":108,"email":424},"Prof. Konstantinos Toutouzas","+30 2132088026","ktoutouz@gmail.com",{"facility":426,"status":185,"city":427,"state":108,"zip":108,"country":413,"countryCode":414,"cosmosGeoPoint":428,"geoPoint":432,"contacts":433},"Hygeia hospital","Marousi",{"type":174,"coordinates":429},[430,431],23.8,38.05,{"lat":431,"lon":430},[434],{"name":435,"role":162,"phone":108,"phoneExt":108,"email":436},"Dr. Konstantinos Spargias","Spargiaskspargias@hygeia.gr",{"facility":438,"status":185,"city":439,"state":108,"zip":440,"country":413,"countryCode":414,"cosmosGeoPoint":441,"geoPoint":445,"contacts":446},"Interbalkan European Medical Center","Thessaloniki","555 35",{"type":174,"coordinates":442},[443,444],22.93493,40.64072,{"lat":444,"lon":443},[447],{"name":448,"role":162,"phone":449,"phoneExt":108,"email":450},"Dr. Vlasis Ninios","+302310400929","vninios@gmail.com",{"facility":452,"status":185,"city":453,"state":108,"zip":454,"country":455,"countryCode":456,"cosmosGeoPoint":457,"geoPoint":461,"contacts":462},"Semmelweis University","Budapest","1122","Hungary","HU",{"type":174,"coordinates":458},[459,460],19.04045,47.49835,{"lat":460,"lon":459},[463,467],{"name":464,"role":162,"phone":465,"phoneExt":108,"email":466},"Prof. Bela Merkely, MD Ph. D","36206632488","merkely.bela@kardio.sote.hu",{"name":468,"role":201,"phone":108,"phoneExt":108,"email":108},"Dr. Roland Papp, MD",{"facility":470,"status":168,"city":471,"state":108,"zip":472,"country":473,"countryCode":474,"cosmosGeoPoint":475,"geoPoint":479,"contacts":480},"University of Bologna Policlinico S. Orsola-Malpigh","Bologna","40141","Italy","IT",{"type":174,"coordinates":476},[477,478],11.33875,44.49381,{"lat":478,"lon":477},[481],{"name":482,"role":162,"phone":108,"phoneExt":108,"email":483},"Dr. Francesco Saia","francescosaia@hotmail.com",{"facility":485,"status":168,"city":486,"state":108,"zip":487,"country":473,"countryCode":474,"cosmosGeoPoint":488,"geoPoint":492,"contacts":493},"Policlinico di Catania","Catania","95100",{"type":174,"coordinates":489},[490,491],15.07041,37.49223,{"lat":491,"lon":490},[494],{"name":495,"role":162,"phone":108,"phoneExt":108,"email":496},"Dr. Corrado Tamburino","tambucor@unict.it",{"facility":498,"status":185,"city":499,"state":108,"zip":500,"country":473,"countryCode":474,"cosmosGeoPoint":501,"geoPoint":505,"contacts":506},"San Donato Hospital","Milan","20121-20162",{"type":174,"coordinates":502},[503,504],9.18951,45.46427,{"lat":504,"lon":503},[507],{"name":508,"role":162,"phone":509,"phoneExt":108,"email":510},"Dr. Francesco Bedogni","+ 39 335 5309117","Francesco.bedogni@grupposandonato.it",{"facility":512,"status":185,"city":499,"state":108,"zip":513,"country":473,"countryCode":474,"cosmosGeoPoint":514,"geoPoint":518,"contacts":519},"San Raffaele Hospital","20132",{"type":174,"coordinates":515},[516,517],12.59836,42.78235,{"lat":517,"lon":516},[520,524],{"name":521,"role":162,"phone":522,"phoneExt":108,"email":523},"Dr. Matteo Montorfano","+39 02 26437331","montorfano.matteo@hsr.it",{"name":525,"role":201,"phone":108,"phoneExt":108,"email":108},"Dr.BELLINI BARBARA",{"facility":527,"status":185,"city":499,"state":108,"zip":528,"country":473,"countryCode":474,"cosmosGeoPoint":529,"geoPoint":531,"contacts":532},"Clinical Institute Saint Ambrogio","20149",{"type":174,"coordinates":530},[516,517],{"lat":517,"lon":516},[533],{"name":534,"role":162,"phone":535,"phoneExt":108,"email":536},"Dr. Alfonso Ielasi","+39 338 8433189","alielasi@hotmail.com",{"facility":538,"status":168,"city":539,"state":108,"zip":540,"country":473,"countryCode":474,"cosmosGeoPoint":541,"geoPoint":545,"contacts":546},"Mauriliano Hospital Largo Filippo","Tortona","10128",{"type":174,"coordinates":542},[543,544],8.86374,44.89784,{"lat":544,"lon":543},[547],{"name":548,"role":162,"phone":108,"phoneExt":108,"email":108},"Prof. Dr. Giuseppe Musumeci",{"facility":550,"status":168,"city":551,"state":108,"zip":552,"country":473,"countryCode":474,"cosmosGeoPoint":553,"geoPoint":557,"contacts":558},"University Hospital Città della Salute e della Scienza Turin Bramante","Turin","10126",{"type":174,"coordinates":554},[555,556],7.68682,45.07049,{"lat":556,"lon":555},[559],{"name":560,"role":162,"phone":561,"phoneExt":108,"email":562},"Prof Gaetano Maria De Ferrari","011 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Patient ≥18 years of age.\n2. Patient or their legal representative has provided written informed consent as approved by the Institutional Review Board (IRB)\u002FInstitutional Ethics Committee (IEC) of the investigational site to participate in the study.\n3. As per local Heart Team assessment, patient is eligible for TAVI and the patient is suitable for implantation with all three study devices.\n\nExclusion Criteria:\n\n1. Patients who are not willing to provide informed consent form, or whose legal heirs object to their participation in the study.\n2. 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