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58","Wroclaw","50-369",{"type":65,"coordinates":631},[632,633],17.03006,51.10286,{"lat":633,"lon":632},[636],{"name":637,"role":52,"phone":638,"phoneExt":54,"email":639},"Dr. Marcin Protasiewicz","+48 71 7364200","marcin.protasiewicz@umed.wwroc.pl",{"facility":641,"status":76,"city":642,"state":54,"zip":643,"country":644,"countryCode":645,"cosmosGeoPoint":646,"geoPoint":650,"contacts":651},"Centro Hospitalar Lisboa Ocidental EPE- Hospital Santa Cruz, Av. Prof. Dr. Reinaldo dos Santos","Carnaxide","2790-134","Portugal","PT",{"type":65,"coordinates":647},[648,649],-9.24671,38.72706,{"lat":649,"lon":648},[652],{"name":653,"role":52,"phone":654,"phoneExt":54,"email":655},"Dr. Manuel Almeida","+351 936359285","almeidams@sapo.pt",{"facility":657,"status":76,"city":658,"state":54,"zip":659,"country":644,"countryCode":645,"cosmosGeoPoint":660,"geoPoint":664,"contacts":665},"Centro Hospital Lisboa Central E.P.E. - Santa Marta","Lisbon","1169-024",{"type":65,"coordinates":661},[662,663],-9.1498,38.72509,{"lat":663,"lon":662},[666],{"name":667,"role":52,"phone":54,"phoneExt":54,"email":668},"Dr. Duarte Cacela","dcacela@hotmail.com",{"facility":670,"status":59,"city":658,"state":54,"zip":671,"country":644,"countryCode":645,"cosmosGeoPoint":672,"geoPoint":674,"contacts":675},"Hospital de Santa Maria, Av. Prof. Egas Moniz MB","1649-028",{"type":65,"coordinates":673},[662,663],{"lat":663,"lon":662},[676],{"name":677,"role":52,"phone":678,"phoneExt":54,"email":679},"Dr. Pedro Carrilho Ferreira","+351 966 412 473","pcarrilhoferreira@gmail.com",{"facility":681,"status":59,"city":682,"state":54,"zip":683,"country":644,"countryCode":645,"cosmosGeoPoint":684,"geoPoint":688,"contacts":689},"Centro Hospitalar de Sao Joao","Porto","4200-319",{"type":65,"coordinates":685},[686,687],-8.61097,41.1485,{"lat":687,"lon":686},[690],{"name":691,"role":52,"phone":54,"phoneExt":54,"email":692},"Dr. Joao Carlos Silva, PhD","joaocebsilva@hotmail.com",{"facility":694,"status":76,"city":695,"state":54,"zip":696,"country":697,"countryCode":698,"cosmosGeoPoint":699,"geoPoint":703,"contacts":704},"University hospital Banska Bystrica Námestie Ludvíka Svobodu 1","Banská Bystrica","975 17","Slovakia","SK",{"type":65,"coordinates":700},[701,702],19.14932,48.73947,{"lat":702,"lon":701},[705],{"name":706,"role":52,"phone":707,"phoneExt":54,"email":708},"Dr. Martin Hudec","+421 918 106033","hudecmt@hotmail.com",{"facility":710,"status":76,"city":711,"state":54,"zip":712,"country":713,"countryCode":714,"cosmosGeoPoint":715,"geoPoint":719,"contacts":720},"University Medical Center, Ljubljana","Ljubljana","1000","Slovenia","SI",{"type":65,"coordinates":716},[717,718],14.50513,46.05108,{"lat":718,"lon":717},[721],{"name":722,"role":52,"phone":723,"phoneExt":54,"email":724},"Prof. Matjaz Bunc, MD, PhD","+38615225050","matjaz.bunc@kclj.si",{"facility":726,"status":76,"city":727,"state":728,"zip":729,"country":730,"countryCode":731,"cosmosGeoPoint":732,"geoPoint":736,"contacts":737},"Hospital Universitari Son Espases Carretera de Valldemossa","Palma de Mallorca","Balearic Islands","07120","Spain","ES",{"type":65,"coordinates":733},[734,735],2.65024,39.56939,{"lat":735,"lon":734},[738,742],{"name":739,"role":52,"phone":740,"phoneExt":54,"email":741},"Dr. Vicente Peral","+34 871205381","vicente.peral@ssib.es",{"name":743,"role":92,"phone":54,"phoneExt":54,"email":54},"Dr. Tania Rdgz Gabella",{"facility":745,"status":76,"city":746,"state":747,"zip":748,"country":730,"countryCode":731,"cosmosGeoPoint":749,"geoPoint":753,"contacts":754},"Hospital Universitario de Gran Canaria Dr Negrin","Las Palmas","Canary Islands","35010",{"type":65,"coordinates":750},[751,752],-16.16555,28.58232,{"lat":752,"lon":751},[755],{"name":756,"role":52,"phone":757,"phoneExt":54,"email":758},"Dr. Pedro Martin Lorenzo","+34928450000","pemarlor@hotmail.com",{"facility":760,"status":76,"city":761,"state":54,"zip":762,"country":730,"countryCode":731,"cosmosGeoPoint":763,"geoPoint":767,"contacts":768},"Hospital Universitario Renei Sofia","Córdoba","5000",{"type":65,"coordinates":764},[765,766],-4.77275,37.89155,{"lat":766,"lon":765},[769],{"name":770,"role":52,"phone":54,"phoneExt":54,"email":771},"Dr. Manuel Pan","manuelpanalvarez@gmail.com",{"facility":773,"status":59,"city":774,"state":54,"zip":775,"country":730,"countryCode":731,"cosmosGeoPoint":776,"geoPoint":780,"contacts":781},"Hospital Clínico San Carlos","Madrid","28040",{"type":65,"coordinates":777},[778,779],-3.70256,40.4165,{"lat":779,"lon":778},[782],{"name":783,"role":52,"phone":784,"phoneExt":54,"email":785},"Dr. Luis Nombela, MD, PhD","+34629510139","luisnombela@yahoo.com",{"facility":787,"status":76,"city":788,"state":54,"zip":789,"country":730,"countryCode":731,"cosmosGeoPoint":790,"geoPoint":794,"contacts":795},"Hospital Cliinico Univertistario de Valladolid","Valladolid","47003",{"type":65,"coordinates":791},[792,793],-4.72353,41.65541,{"lat":793,"lon":792},[796,800],{"name":797,"role":52,"phone":798,"phoneExt":54,"email":799},"Dr. Ignacio A Santos, Medicine & Surgery","+34657923040","ijamat@gmail.com",{"name":801,"role":92,"phone":54,"phoneExt":54,"email":54},"Dr. Juan Pablo Sánchez Luna, MD, PhD",{"facility":803,"status":76,"city":804,"state":54,"zip":54,"country":805,"countryCode":806,"cosmosGeoPoint":807,"geoPoint":811,"contacts":812},"Sahlgrenska University Hospital","Gothenburg","Sweden","SE",{"type":65,"coordinates":808},[809,810],11.96679,57.70716,{"lat":810,"lon":809},[813],{"name":814,"role":52,"phone":54,"phoneExt":54,"email":815},"Dr. Oskar Angreas","oskar.angeras@vgregion.se",{"facility":817,"status":76,"city":818,"state":54,"zip":54,"country":805,"countryCode":806,"cosmosGeoPoint":819,"geoPoint":823,"contacts":824},"Uppsala University Hospital","Uppsala",{"type":65,"coordinates":820},[821,822],17.63889,59.85882,{"lat":822,"lon":821},[825],{"name":826,"role":52,"phone":54,"phoneExt":54,"email":827},"Prof. Stefan James","stefan.james@ucr.uu.se",{"type":829,"investigatorFullName":54,"investigatorTitle":54,"investigatorAffiliation":54,"oldNameTitle":54,"oldOrganization":54},"SPONSOR","100383674","landmark-trial-a-randomised-controlled-trial-of-myval-thv-100383674",false,"NCT04275726","LANDMARK Trial: a Randomised Controlled Trial of Myval THV","A Prospective, Multinational, Multicentre, Open-label, Randomised, Non-inferiority Trial to Compare Safety and Effectiveness of Meril's Myval Transcatheter Heart Valve (THV) Series vs. Contemporary Valves (Edwards's Sapien THV Series and Medtronic's Evolut THV Series) in Patients With Severe Symptomatic Native Aortic Valve Stenosis","LANDMARK","Inclusion Criteria:\n\n1. 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. Any condition, which in the Investigator's opinion, would preclude safe participation of patient in the study.","ALL","18 Years",{"count":841,"type":842},988,"ESTIMATED","INTERVENTIONAL",[845],"NA","The primary objective of this study (LANDMARK) is to compare the safety and effectiveness of the Myval THV Series with Contemporary Valves (Sapien THV Series and Evolut THV Series) in patients with severe symptomatic native aortic valve stenosis.\n\nThis study will be done in total 768 subjects (384:384, Myval THV Series vs. Contemporary Valves)\n\nThe 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)",[848],"Aortic Valve Stenosis",[850,851,852],"LANDMARK Trial","Trial to evaluate safety & effectiveness of Myval THV","CE Approved Myval THV Series","2025-04-01",{"date":855,"type":856},"2025-04-04","ACTUAL",{"date":858,"type":856},"2020-11-04",{"date":860,"type":842},"2033-12-31",{"name":5,"class":6},54]