[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100443945":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":26,"locations":35,"responsibleParty":386,"collaborators":20,"id":388,"slug":389,"hasResults":390,"nctId":391,"briefTitle":392,"officialTitle":392,"acronym":20,"eligibilityCriteria":393,"healthyVolunteers":390,"sex":394,"minAge":395,"maxAge":20,"enrollmentInfo":396,"targetDuration":20,"studyType":399,"phases":400,"briefSummary":402,"conditions":403,"keywords":20,"overallStatus":56,"whyStopped":20,"lastUpdateSubmitDate":405,"lastUpdatePostDateStruct":406,"startDateStruct":409,"completionDateStruct":411,"leadSponsor":413,"locationsCount":414},{"fullName":5,"class":6},"Abbott Medical Devices","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Treatment","EXPERIMENTAL","Treatment of symptomatic patients with mitral valve disease (including mitral regurgitation, mitral stenosis and mixed mitral valve disease) with the Cephea Mitral Valve System",[13],"Device: Cephea Mitral Valve System",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","Cephea Mitral Valve System","Transcatheter mitral valve replacement",[9],null,[22],{"name":23,"affiliation":24,"role":25},"Barathi Sethuraman","Abbott Structural Heart","STUDY_DIRECTOR",[27,32],{"name":28,"role":29,"phone":30,"phoneExt":20,"email":31},"Leslie Centeno","CONTACT","+1 818-294-3041","leslie.centeno@abbott.com",{"name":33,"role":29,"phone":20,"phoneExt":20,"email":34},"Clinical Project Manager","Cephea_FS@abbott.com",[36,54,72,88,104,121,136,153,170,187,204,220,236,252,269,286,303,315,331,348,364,376],{"facility":37,"status":38,"city":39,"state":40,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"Banner-University Medical Center Phoenix","NOT_YET_RECRUITING","Phoenix","Arizona","85006","United States","US",{"type":45,"coordinates":46},"Point",[47,48],-112.07404,33.44838,{"lat":48,"lon":47},[51],{"name":52,"role":53,"phone":20,"phoneExt":20,"email":20},"Paul Sorajja, MD","PRINCIPAL_INVESTIGATOR",{"facility":55,"status":56,"city":57,"state":58,"zip":59,"country":42,"countryCode":43,"cosmosGeoPoint":60,"geoPoint":64,"contacts":65},"Cedars-Sinai Medical Center","RECRUITING","Los Angeles","California","90048",{"type":45,"coordinates":61},[62,63],-118.24368,34.05223,{"lat":63,"lon":62},[66,70],{"name":67,"role":29,"phone":68,"phoneExt":20,"email":69},"Andjela Kremenovic","417-353-7177","Andjela.Kremenovic@cshs.org",{"name":71,"role":53,"phone":20,"phoneExt":20,"email":20},"Raj Makkar, MD",{"facility":73,"status":56,"city":74,"state":58,"zip":75,"country":42,"countryCode":43,"cosmosGeoPoint":76,"geoPoint":80,"contacts":81},"University of California - Davis Medical Center","Sacramento","95817",{"type":45,"coordinates":77},[78,79],-121.4944,38.58157,{"lat":79,"lon":78},[82,86],{"name":83,"role":29,"phone":84,"phoneExt":20,"email":85},"Heather Houston","916-734-5155","hhouston@ucdavis.edu",{"name":87,"role":53,"phone":20,"phoneExt":20,"email":20},"Jason Rogers, MD",{"facility":89,"status":56,"city":90,"state":58,"zip":91,"country":42,"countryCode":43,"cosmosGeoPoint":92,"geoPoint":96,"contacts":97},"Los Robles Regional Medical Center","Thousand Oaks","91360",{"type":45,"coordinates":93},[94,95],-118.83759,34.17056,{"lat":95,"lon":94},[98,102],{"name":99,"role":29,"phone":100,"phoneExt":20,"email":101},"Mane Arabyan","(805) 796-3746","Mane.arabyan@hcahealthcare.com",{"name":103,"role":53,"phone":20,"phoneExt":20,"email":20},"Saibal Kar, MD",{"facility":105,"status":56,"city":106,"state":107,"zip":108,"country":42,"countryCode":43,"cosmosGeoPoint":109,"geoPoint":113,"contacts":114},"Emory University Hospital","Atlanta","Georgia","30308",{"type":45,"coordinates":110},[111,112],-84.38798,33.749,{"lat":112,"lon":111},[115,119],{"name":116,"role":29,"phone":117,"phoneExt":20,"email":118},"Elizabeth Charles","(404) 686-1249","elizabeth.z.charles@emory.edu",{"name":120,"role":53,"phone":20,"phoneExt":20,"email":20},"Adam Greenbaum, MD",{"facility":122,"status":56,"city":106,"state":107,"zip":123,"country":42,"countryCode":43,"cosmosGeoPoint":124,"geoPoint":126,"contacts":127},"Piedmont Heart Institute","30309",{"type":45,"coordinates":125},[111,112],{"lat":112,"lon":111},[128,132,134],{"name":129,"role":29,"phone":130,"phoneExt":20,"email":131},"Danielle Griffith","404-605-2958","Danielle.griffith@piedmont.org",{"name":133,"role":53,"phone":20,"phoneExt":20,"email":20},"Vinod Thourani, MD",{"name":135,"role":53,"phone":20,"phoneExt":20,"email":20},"Pradeep Yadav, MD",{"facility":137,"status":56,"city":138,"state":139,"zip":140,"country":42,"countryCode":43,"cosmosGeoPoint":141,"geoPoint":145,"contacts":146},"Northwestern Memorial Hospital","Chicago","Illinois","60611",{"type":45,"coordinates":142},[143,144],-87.65005,41.85003,{"lat":144,"lon":143},[147,151],{"name":148,"role":29,"phone":149,"phoneExt":20,"email":150},"Maggie McNamara","312-926-0846","margaret.mcnamara@nm.org",{"name":152,"role":53,"phone":20,"phoneExt":20,"email":20},"Anita Asgar, MD",{"facility":154,"status":56,"city":155,"state":156,"zip":157,"country":42,"countryCode":43,"cosmosGeoPoint":158,"geoPoint":162,"contacts":163},"Via Christi Regional Medical Center - St. Francis Campus","Wichita","Kansas","67214",{"type":45,"coordinates":159},[160,161],-97.33754,37.69224,{"lat":161,"lon":160},[164,168],{"name":165,"role":29,"phone":166,"phoneExt":20,"email":167},"Lindsey Steele","316-268-8092","lindsey.steele@ascension.org",{"name":169,"role":53,"phone":20,"phoneExt":20,"email":20},"Bassem Chehab, MD",{"facility":171,"status":56,"city":172,"state":173,"zip":174,"country":42,"countryCode":43,"cosmosGeoPoint":175,"geoPoint":179,"contacts":180},"University of Michigan - Davis Medical Center","Ann Arbor","Michigan","48109",{"type":45,"coordinates":176},[177,178],-83.74088,42.27756,{"lat":178,"lon":177},[181,185],{"name":182,"role":29,"phone":183,"phoneExt":20,"email":184},"Allison Schley","734-232-4319","schleya@med.umich.edu",{"name":186,"role":53,"phone":20,"phoneExt":20,"email":20},"Gorav Ailawadi, MD",{"facility":188,"status":56,"city":189,"state":190,"zip":191,"country":42,"countryCode":43,"cosmosGeoPoint":192,"geoPoint":196,"contacts":197},"Minneapolis Heart Institute","Minneapolis","Minnesota","55407",{"type":45,"coordinates":193},[194,195],-93.26384,44.97997,{"lat":195,"lon":194},[198,202],{"name":199,"role":29,"phone":200,"phoneExt":20,"email":201},"Jennifer Nguyen","612-863-9291","Jennifer.nguyen@allina.com",{"name":203,"role":53,"phone":20,"phoneExt":20,"email":20},"Mario Goessl, MD",{"facility":205,"status":56,"city":206,"state":206,"zip":207,"country":42,"countryCode":43,"cosmosGeoPoint":208,"geoPoint":212,"contacts":213},"New York-Presbyterian\u002FColumbia University Medical Center","New York","10032",{"type":45,"coordinates":209},[210,211],-74.00597,40.71427,{"lat":211,"lon":210},[214,218],{"name":215,"role":29,"phone":216,"phoneExt":20,"email":217},"Kate Dalton","212-342-1820","keb2114@columbia.edu",{"name":219,"role":53,"phone":20,"phoneExt":20,"email":20},"Torsten Vahl",{"facility":221,"status":56,"city":222,"state":206,"zip":223,"country":42,"countryCode":43,"cosmosGeoPoint":224,"geoPoint":228,"contacts":229},"Montefiore Medical Center - Moses Campus","The Bronx","10467",{"type":45,"coordinates":225},[226,227],-73.86641,40.84985,{"lat":227,"lon":226},[230,234],{"name":231,"role":29,"phone":232,"phoneExt":20,"email":233},"Tammy Rodriguez Guzman","(718) 920-6523","tamrodrigu@montefiore.org",{"name":235,"role":53,"phone":20,"phoneExt":20,"email":20},"Mohamed Azeem Latib, MD",{"facility":237,"status":56,"city":238,"state":239,"zip":240,"country":42,"countryCode":43,"cosmosGeoPoint":241,"geoPoint":245,"contacts":246},"Atrium Health - Carolinas Medical Center","Charlotte","North Carolina","28203",{"type":45,"coordinates":242},[243,244],-80.84313,35.22709,{"lat":244,"lon":243},[247,250],{"name":248,"role":29,"phone":20,"phoneExt":20,"email":249},"Montana Bright","montana.bright@atriumhealth.org",{"name":251,"role":53,"phone":20,"phoneExt":20,"email":20},"Michael Rinaldi, MD",{"facility":253,"status":56,"city":254,"state":255,"zip":256,"country":42,"countryCode":43,"cosmosGeoPoint":257,"geoPoint":261,"contacts":262},"The Cleveland Clinic Foundation","Cleveland","Ohio","44195",{"type":45,"coordinates":258},[259,260],-81.69541,41.4995,{"lat":260,"lon":259},[263,267],{"name":264,"role":29,"phone":265,"phoneExt":20,"email":266},"Emily Tylicki","216-444-6950","tylicke@ccf.org",{"name":268,"role":53,"phone":20,"phoneExt":20,"email":20},"Samir Kapadia, MD",{"facility":270,"status":56,"city":271,"state":272,"zip":273,"country":42,"countryCode":43,"cosmosGeoPoint":274,"geoPoint":278,"contacts":279},"Allegheny General Hospital - ASRI","Pittsburgh","Pennsylvania","15212",{"type":45,"coordinates":275},[276,277],-79.99589,40.44062,{"lat":277,"lon":276},[280,284],{"name":281,"role":29,"phone":282,"phoneExt":20,"email":283},"Tracy Spirk","(412) 359-4025","tracy.spirk@ahn.org",{"name":285,"role":53,"phone":20,"phoneExt":20,"email":20},"Walter McGregor, MD",{"facility":287,"status":56,"city":288,"state":289,"zip":290,"country":42,"countryCode":43,"cosmosGeoPoint":291,"geoPoint":295,"contacts":296},"Ascension Saint Thomas","Nashville","Tennessee","37205",{"type":45,"coordinates":292},[293,294],-86.78444,36.16589,{"lat":294,"lon":293},[297,301],{"name":298,"role":29,"phone":299,"phoneExt":20,"email":300},"Kolie Gasaway","(615) 222-3227","kolie.gasaway@ascension.org",{"name":302,"role":53,"phone":20,"phoneExt":20,"email":20},"Evelio Rodriguez, MD",{"facility":304,"status":56,"city":288,"state":289,"zip":305,"country":42,"countryCode":43,"cosmosGeoPoint":306,"geoPoint":308,"contacts":309},"Vanderbilt Heart & Vascular Institute","37208",{"type":45,"coordinates":307},[293,294],{"lat":294,"lon":293},[310,313],{"name":311,"role":29,"phone":20,"phoneExt":20,"email":312},"Kathryn Adams","kathy.adams@vumc.org",{"name":314,"role":53,"phone":20,"phoneExt":20,"email":20},"Kashish Goel",{"facility":316,"status":56,"city":317,"state":318,"zip":319,"country":42,"countryCode":43,"cosmosGeoPoint":320,"geoPoint":324,"contacts":325},"Houston Methodist","Houston","Texas","77030",{"type":45,"coordinates":321},[322,323],-95.36327,29.76328,{"lat":323,"lon":322},[326,329],{"name":327,"role":29,"phone":20,"phoneExt":20,"email":328},"Deena Victor","dcvictor@HoustonMethodist.org",{"name":330,"role":53,"phone":20,"phoneExt":20,"email":20},"Sachin Goel, MD",{"facility":332,"status":56,"city":333,"state":334,"zip":335,"country":42,"countryCode":43,"cosmosGeoPoint":336,"geoPoint":340,"contacts":341},"Sentara Norfolk General Hospital","Norfolk","Virginia","23507",{"type":45,"coordinates":337},[338,339],-76.28522,36.84681,{"lat":339,"lon":338},[342,346],{"name":343,"role":29,"phone":344,"phoneExt":20,"email":345},"Christine Calayo","(757) 388-3876","cacalayo@sentara.com",{"name":347,"role":53,"phone":20,"phoneExt":20,"email":20},"Matthew Summers, MD",{"facility":349,"status":56,"city":350,"state":351,"zip":352,"country":42,"countryCode":43,"cosmosGeoPoint":353,"geoPoint":357,"contacts":358},"Swedish Medical Center","Seattle","Washington","98122",{"type":45,"coordinates":354},[355,356],-122.33207,47.60621,{"lat":356,"lon":355},[359,362],{"name":360,"role":29,"phone":20,"phoneExt":20,"email":361},"Jennifer Nagel","jennifer.nagel@swedish.org",{"name":363,"role":53,"phone":20,"phoneExt":20,"email":20},"Sameer Gafoor, MD",{"facility":365,"status":366,"city":367,"state":368,"zip":20,"country":369,"countryCode":370,"cosmosGeoPoint":371,"geoPoint":375,"contacts":20},"Institut de Cardiologie de Montreal","COMPLETED","Montreal","Quebec","Canada","CA",{"type":45,"coordinates":372},[373,374],-73.58781,45.50884,{"lat":374,"lon":373},{"facility":377,"status":378,"city":379,"state":368,"zip":380,"country":369,"countryCode":370,"cosmosGeoPoint":381,"geoPoint":385,"contacts":20},"IUCPQ-ULaval","WITHDRAWN","Québec","G1V 4G5",{"type":45,"coordinates":382},[383,384],-71.21454,46.81228,{"lat":384,"lon":383},{"type":387,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100443945","cephea-early-feasibility-study-100443945",false,"NCT05061004","Cephea Early Feasibility Study","Key Inclusion Criteria:\n\n* Mitral valve disease resulting in mitral regurgitation (MR ≥ Grade III) and\u002For severe mitral valve stenosis (mitral valve area ≤ 1.5cm²) per American Society of Echocardiography criteria.\n* LVEF ≥ 30%\n* In the judgement of the Site Heart Team, transcatheter therapy is deemed more appropriate than open heart surgery.\n\nKey Exclusion Criteria:\n\n* Prior surgical or interventional treatment that interferes with the Cephea valve delivery or function.\n* Need for emergent or urgent surgery.","ALL","18 Years",{"count":397,"type":398},50,"ESTIMATED","INTERVENTIONAL",[401],"NA","The objective of this study is to evaluate the preliminary safety and effectiveness of the Cephea Mitral Valve System for the treatment of symptomatic patients with mitral valve disease (including mitral regurgitation, mitral stenosis and mixed mitral valve disease) in whom transcatheter therapy is deemed more appropriate than open heart surgery.",[404],"Mitral Regurgitation","2026-04-07",{"date":407,"type":408},"2026-04-08","ACTUAL",{"date":410,"type":408},"2022-04-28",{"date":412,"type":398},"2031-03-01",{"name":5,"class":6},22]