[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05061004":3,"trial-entities:NCT05061004":375,"trial-summary:NCT05061004":380},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":14,"conditions":16,"keywords":18,"study_type":19,"primary_purpose":20,"phases":21,"enrollment_info":23,"interventions":26,"primary_outcomes":33,"secondary_outcomes":41,"sex":42,"minimum_age":43,"maximum_age":14,"healthy_volunteers":44,"eligibility_criteria":45,"std_ages":54,"locations":57,"central_contacts":360,"overall_officials":368,"references":373,"see_also_links":374},"NCT05061004","ABT-CIP-10354","Cephea Early Feasibility Study","RECRUITING","2031-03-01","2025-12","2026-07-08","2022-04-28","Abbott Medical Devices","INDUSTRY",null,"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.",[17],"Mitral Regurgitation",[],"INTERVENTIONAL","TREATMENT",[22],"NA",{"count":24,"type":25},50,"ESTIMATED",[27],{"type":28,"name":29,"description":30,"armGroupLabels":31},"DEVICE","Cephea Mitral Valve System","Transcatheter mitral valve replacement",[32],"Treatment",[34,38],{"measure":35,"description":36,"timeFrame":37},"Primary Safety Endpoint","Freedom from all-cause mortality, which will be assessed at 30 days post implant.","30 days post implant",{"measure":39,"description":40,"timeFrame":37},"Primary Effectiveness Endpoint","Proportion of subjects with reduction of MR to ≤ Grade I, will be assessed at 30 days post implant.",[],"ALL","18 Years",false,{"inclusion":46,"exclusion":50,"raw_text":53},[47,48,49],"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.","LVEF ≥ 30%","In the judgement of the Site Heart Team, transcatheter therapy is deemed more appropriate than open heart surgery.",[51,52],"Prior surgical or interventional treatment that interferes with the Cephea valve delivery or function.","Need for emergent or urgent surgery.","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.",[55,56],"ADULT","OLDER_ADULT",[58,71,87,101,115,130,143,158,173,188,203,217,231,245,260,275,290,300,314,329,343,352],{"facility":59,"status":7,"city":60,"state":61,"zip":62,"country":63,"contacts":64,"geoPoint":68},"Banner-University Medical Center Phoenix","Phoenix","Arizona","85006","United States",[65],{"name":66,"role":67},"Paul Sorajja, MD","PRINCIPAL_INVESTIGATOR",{"lat":69,"lon":70},33.44838,-112.07404,{"facility":72,"status":7,"city":73,"state":74,"zip":75,"country":63,"contacts":76,"geoPoint":84},"Cedars-Sinai Medical Center","Los Angeles","California","90048",[77,82],{"name":78,"role":79,"phone":80,"email":81},"Andjela Kremenovic","CONTACT","417-353-7177","Andjela.Kremenovic@cshs.org",{"name":83,"role":67},"Raj Makkar, MD",{"lat":85,"lon":86},34.05223,-118.24368,{"facility":88,"status":7,"city":89,"state":74,"zip":90,"country":63,"contacts":91,"geoPoint":98},"University of California - Davis Medical Center","Sacramento","95817",[92,96],{"name":93,"role":79,"phone":94,"email":95},"Heather Houston","916-734-5155","hhouston@ucdavis.edu",{"name":97,"role":67},"Jason Rogers, MD",{"lat":99,"lon":100},38.58157,-121.4944,{"facility":102,"status":7,"city":103,"state":74,"zip":104,"country":63,"contacts":105,"geoPoint":112},"Los Robles Regional Medical Center","Thousand Oaks","91360",[106,110],{"name":107,"role":79,"phone":108,"email":109},"Mane Arabyan","805-796-3746","Mane.arabyan@hcahealthcare.com",{"name":111,"role":67},"Saibal Kar, MD",{"lat":113,"lon":114},34.17056,-118.83759,{"facility":116,"status":7,"city":117,"state":118,"zip":119,"country":63,"contacts":120,"geoPoint":127},"Emory University Hospital","Atlanta","Georgia","30308",[121,125],{"name":122,"role":79,"phone":123,"email":124},"Elizabeth Charles","404-686-1249","elizabeth.z.charles@emory.edu",{"name":126,"role":67},"Adam Greenbaum, MD",{"lat":128,"lon":129},33.749,-84.38798,{"facility":131,"status":7,"city":117,"state":118,"zip":132,"country":63,"contacts":133,"geoPoint":142},"Piedmont Heart Institute","30309",[134,138,140],{"name":135,"role":79,"phone":136,"email":137},"Danielle Griffith","404-605-2958","Danielle.griffith@piedmont.org",{"name":139,"role":67},"Vinod Thourani, MD",{"name":141,"role":67},"Pradeep Yadav, MD",{"lat":128,"lon":129},{"facility":144,"status":7,"city":145,"state":146,"zip":147,"country":63,"contacts":148,"geoPoint":155},"Northwestern Memorial Hospital","Chicago","Illinois","60611",[149,153],{"name":150,"role":79,"phone":151,"email":152},"Maggie McNamara","312-926-0846","margaret.mcnamara@nm.org",{"name":154,"role":67},"Anita Asgar, MD",{"lat":156,"lon":157},41.85003,-87.65005,{"facility":159,"status":7,"city":160,"state":161,"zip":162,"country":63,"contacts":163,"geoPoint":170},"Ascension Via Christi Hospitals Wichita","Wichita","Kansas","67214",[164,168],{"name":165,"role":79,"phone":166,"email":167},"Lindsey Steele","316-268-8092","lindsey.steele@ascension.org",{"name":169,"role":67},"Bassem Chehab, MD",{"lat":171,"lon":172},37.69224,-97.33754,{"facility":174,"status":7,"city":175,"state":176,"zip":177,"country":63,"contacts":178,"geoPoint":185},"University of Michigan - Davis Medical Center","Ann Arbor","Michigan","48109",[179,183],{"name":180,"role":79,"phone":181,"email":182},"Allison Schley","734-232-4319","schleya@med.umich.edu",{"name":184,"role":67},"Gorav Ailawadi, MD",{"lat":186,"lon":187},42.27756,-83.74088,{"facility":189,"status":7,"city":190,"state":191,"zip":192,"country":63,"contacts":193,"geoPoint":200},"Minneapolis Heart Institute","Minneapolis","Minnesota","55407",[194,198],{"name":195,"role":79,"phone":196,"email":197},"Jennifer Nguyen","612-863-9291","Jennifer.nguyen@allina.com",{"name":199,"role":67},"Mario Goessl, MD",{"lat":201,"lon":202},44.97997,-93.26384,{"facility":204,"status":7,"city":205,"state":205,"zip":206,"country":63,"contacts":207,"geoPoint":214},"New York-Presbyterian\u002FColumbia University Medical Center","New York","10032",[208,212],{"name":209,"role":79,"phone":210,"email":211},"Kate Dalton","212-342-1820","keb2114@columbia.edu",{"name":213,"role":67},"Torsten Vahl",{"lat":215,"lon":216},40.71427,-74.00597,{"facility":218,"status":7,"city":219,"state":205,"zip":220,"country":63,"contacts":221,"geoPoint":228},"Montefiore Medical Center - Moses Campus","The Bronx","10467",[222,226],{"name":223,"role":79,"phone":224,"email":225},"Tammy Rodriguez Guzman","718-920-6523","tamrodrigu@montefiore.org",{"name":227,"role":67},"Mohamed Azeem Latib, MD",{"lat":229,"lon":230},40.84985,-73.86641,{"facility":232,"status":7,"city":233,"state":234,"zip":235,"country":63,"contacts":236,"geoPoint":242},"Atrium Health - Carolinas Medical Center","Charlotte","North Carolina","28203",[237,240],{"name":238,"role":79,"email":239},"Montana Bright","montana.bright@atriumhealth.org",{"name":241,"role":67},"Michael Rinaldi, MD",{"lat":243,"lon":244},35.22709,-80.84313,{"facility":246,"status":7,"city":247,"state":248,"zip":249,"country":63,"contacts":250,"geoPoint":257},"The Cleveland Clinic Foundation","Cleveland","Ohio","44195",[251,255],{"name":252,"role":79,"phone":253,"email":254},"Emily Tylicki","216-444-6950","tylicke@ccf.org",{"name":256,"role":67},"Samir Kapadia, MD",{"lat":258,"lon":259},41.4995,-81.69541,{"facility":261,"status":7,"city":262,"state":263,"zip":264,"country":63,"contacts":265,"geoPoint":272},"Allegheny General Hospital - ASRI","Pittsburgh","Pennsylvania","15212",[266,270],{"name":267,"role":79,"phone":268,"email":269},"Tracy Spirk","412-359-4025","tracy.spirk@ahn.org",{"name":271,"role":67},"Walter McGregor, MD",{"lat":273,"lon":274},40.44062,-79.99589,{"facility":276,"status":7,"city":277,"state":278,"zip":279,"country":63,"contacts":280,"geoPoint":287},"Ascension Saint Thomas","Nashville","Tennessee","37205",[281,285],{"name":282,"role":79,"phone":283,"email":284},"Kolie Gasaway","615-222-3227","kolie.gasaway@ascension.org",{"name":286,"role":67},"Evelio Rodriguez, MD",{"lat":288,"lon":289},36.16589,-86.78444,{"facility":291,"status":7,"city":277,"state":278,"zip":292,"country":63,"contacts":293,"geoPoint":299},"Vanderbilt Heart & Vascular Institute","37208",[294,297],{"name":295,"role":79,"email":296},"Kathryn Adams","kathy.adams@vumc.org",{"name":298,"role":67},"Kashish Goel",{"lat":288,"lon":289},{"facility":301,"status":7,"city":302,"state":303,"zip":304,"country":63,"contacts":305,"geoPoint":311},"Houston Methodist","Houston","Texas","77030",[306,309],{"name":307,"role":79,"email":308},"Deena Victor","dcvictor@HoustonMethodist.org",{"name":310,"role":67},"Sachin Goel, MD",{"lat":312,"lon":313},29.76328,-95.36327,{"facility":315,"status":7,"city":316,"state":317,"zip":318,"country":63,"contacts":319,"geoPoint":326},"Sentara Norfolk General Hospital","Norfolk","Virginia","23507",[320,324],{"name":321,"role":79,"phone":322,"email":323},"Christine Calayo","757-388-3876","cacalayo@sentara.com",{"name":325,"role":67},"Matthew Summers, MD",{"lat":327,"lon":328},36.84681,-76.28522,{"facility":330,"status":7,"city":331,"state":332,"zip":333,"country":63,"contacts":334,"geoPoint":340},"Swedish Medical Center","Seattle","Washington","98122",[335,338],{"name":336,"role":79,"email":337},"Jennifer Nagel","jennifer.nagel@swedish.org",{"name":339,"role":67},"Sameer Gafoor, MD",{"lat":341,"lon":342},47.60621,-122.33207,{"facility":344,"status":345,"city":346,"state":347,"country":348,"geoPoint":349},"Institut de Cardiologie de Montreal","COMPLETED","Montreal","Quebec","Canada",{"lat":350,"lon":351},45.50884,-73.58781,{"facility":353,"status":354,"city":355,"state":347,"zip":356,"country":348,"geoPoint":357},"IUCPQ-ULaval","WITHDRAWN","Québec","G1V 4G5",{"lat":358,"lon":359},46.81228,-71.21454,[361,365],{"name":362,"role":79,"phone":363,"email":364},"Leslie Centeno","+1 818-294-3041","leslie.centeno@abbott.com",{"name":366,"role":79,"email":367},"Clinical Project Manager","Cephea_FS@abbott.com",[369],{"name":370,"affiliation":371,"role":372},"Barathi Sethuraman","Abbott Structural Heart","STUDY_DIRECTOR",[],[],{"nct_id":4,"conditions":376,"biomarkers":379},[377,378],"Mitral Valve Insufficiency","Mitral Valve Stenosis",[],{"nct_id":4,"found":381,"summary":382,"prompt_version":392},true,{"design":383,"status":384,"heading":385,"summary":386,"follow_up":387,"word_count":388,"commitments":389,"compensation":390,"drugs_mentioned":391},"This is an interventional study planning to enroll 50 participants. The study is evaluating a medical device.","completed","Cephea Early Feasibility Study for Mitral Valve Disease","This study is testing a new device called the Cephea Mitral Valve System. This system is designed to replace your mitral valve without open-heart surgery, which is a procedure called transcatheter mitral valve replacement. The study aims to see how safe and effective the Cephea Mitral Valve System is for people with symptomatic mitral valve disease, including mitral regurgitation (a leaky heart valve) or mitral stenosis (a narrowed heart valve). You might be able to join if your heart team believes this less invasive procedure is a better option for you than traditional surgery. The study will measure success by looking at safety and effectiveness 30 days after the device is implanted. The current recruitment status is unclear.","Participants will be followed for safety and effectiveness for 30 days after the device is implanted.",118,"Not specified in the trial record.","Not stated in the trial record.",[29],"v2"]