[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07069673":3,"trial-entities:NCT07069673":382,"trial-summary:NCT07069673":388},{"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":16,"conditions":17,"keywords":25,"study_type":28,"primary_purpose":16,"phases":29,"enrollment_info":30,"interventions":33,"primary_outcomes":34,"secondary_outcomes":39,"sex":40,"minimum_age":41,"maximum_age":16,"healthy_volunteers":14,"eligibility_criteria":42,"std_ages":46,"locations":49,"central_contacts":374,"overall_officials":379,"references":380,"see_also_links":381},"NCT07069673","ABT-CIP-10593","Abbott Cephea Mitral Valve Disease Registry","RECRUITING","2028-12","2026-06","2026-06-22","2025-08-13","Abbott Medical Devices","INDUSTRY",false,"The objective of this registry is to gather clinical data on symptomatic patients with mitral valve disease, including patients with mitral regurgitation, mitral stenosis, and mixed mitral valve disease. Data collected from this registry are expected to improve our understanding of the impact of correcting symptomatic mitral valve disease on clinical outcomes in patients that could be candidates for Transcatheter Mitral Valve Replacement and may also inform future regulatory or reimbursement submission strategies for the Cephea Mitral Valve System.",null,[18,19,20,21,22,23,24],"Mitral Regurgitation","Mitral Stenosis","Mitral Valve Disease","Mitral Valve (MV) Regurgitation","Mitral Annulus Calcification","Mitral Valve Replacement","Transcatheter Valve Replacement",[20,26,27],"registry","Cephea Mitral Valve System","OBSERVATIONAL",[],{"count":31,"type":32},1000,"ESTIMATED",[],[35],{"measure":36,"description":37,"timeFrame":38},"Primary Objective","The objective of the MVD Registry is to collect data on the progression of MVD patients considered for TMVR therapy to guide product development, regulatory submissions, and reimbursement planning","From enrollment to 2 years of follow-up",[],"ALL","18 Years",{"inclusion":43,"exclusion":44,"raw_text":45},[],[],"Inclusion Criteria:\n\n1. Symptomatic mitral valve disease resulting in mitral regurgitation and\u002For severe mitral valve stenosis.\n2. New York Heart Association (NYHA) Functional Class II, III, or ambulatory IV.\n3. In the judgement of the Site Heart Team, transcatheter therapy is deemed to be more appropriate than conventional mitral valve surgery, TMVR is more likely to provide an optimal result than TEER, and the subject has been adequately treated per applicable standards, including for coronary artery disease, left ventricular dysfunction, and heart failure.\n4. Age 18 years or older at time of consent.\n5. The subject agrees to the study requirements, permits all follow-up data entry, and has provided written informed consent.\n\nExclusion Criteria:\n\n1. Prior surgical or interventional treatment that interferes with the Cephea valve delivery or function.\n2. Subject is undergoing dialysis or experiencing chronic renal failure\n3. Subject has chronic lung disease requiring continuous home oxygen therapy or chronic outpatient oral steroid use\n4. Subjects with comorbidities that are likely to result in a life expectancy of less than 12 months.\n5. Pregnant or nursing subjects and those who plan pregnancy during the follow-up period.",[47,48],"ADULT","OLDER_ADULT",[50,68,83,98,113,124,139,154,169,184,199,214,227,242,257,271,286,300,310,320,334,344,359],{"facility":51,"status":7,"city":52,"state":53,"zip":54,"country":55,"contacts":56,"geoPoint":65},"University Hospital - Univ. of Alabama at Birmingham (UAB)","Birmingham","Alabama","35233","United States",[57,62],{"name":58,"role":59,"phone":60,"email":61},"Marissa Waite","CONTACT","205-659-5660","mwaite@uabmc.edu",{"name":63,"role":64},"Mustafa Ahmed, MD","PRINCIPAL_INVESTIGATOR",{"lat":66,"lon":67},33.52066,-86.80249,{"facility":69,"status":7,"city":70,"state":71,"zip":72,"country":55,"contacts":73,"geoPoint":80},"Phoenix Cardiovascular Research Group","Phoenix","Arizona","85016",[74,78],{"name":75,"role":59,"phone":76,"email":77},"Jessica Byrne","602-952-0002","jessicabyrne@pcrg.hush.com",{"name":79,"role":64},"Timothy Byrne, DO, FACC",{"lat":81,"lon":82},33.44838,-112.07404,{"facility":84,"status":7,"city":85,"state":86,"zip":87,"country":55,"contacts":88,"geoPoint":95},"Los Robles Regional Medical Center","Thousand Oaks","California","91360",[89,93],{"name":90,"role":59,"phone":91,"email":92},"Jason Yashar","310-423-0782","Jason.Yashar@HCAHealthcare.com",{"name":94,"role":64},"Saibal Kar, MD",{"lat":96,"lon":97},34.17056,-118.83759,{"facility":99,"status":7,"city":100,"state":101,"zip":102,"country":55,"contacts":103,"geoPoint":110},"Piedmont Heart Institute","Atlanta","Georgia","30309",[104,108],{"name":105,"role":59,"phone":106,"email":107},"Danielle Griffith","404-605-2958","Danielle.griffith@piedmont.org",{"name":109,"role":64},"Pradeep Yadav, MD",{"lat":111,"lon":112},33.749,-84.38798,{"facility":114,"status":7,"city":100,"state":101,"zip":115,"country":55,"contacts":116,"geoPoint":123},"Emory University Hospital","30322",[117,121],{"name":118,"role":59,"phone":119,"email":120},"Elizabeth Charles, MPH","404-686-1249","elizabeth.z.charles@emory.edu",{"name":122,"role":64},"Adam Greenbaum, MD",{"lat":111,"lon":112},{"facility":125,"status":7,"city":126,"state":127,"zip":128,"country":55,"contacts":129,"geoPoint":136},"Northwestern Memorial Hospital","Chicago","Illinois","60611",[130,134],{"name":131,"role":59,"phone":132,"email":133},"Maggie McNamara","312-926-0846","margaret.mcnamara@nm.org",{"name":135,"role":64},"Anita Asgar, MD",{"lat":137,"lon":138},41.85003,-87.65005,{"facility":140,"status":7,"city":141,"state":142,"zip":143,"country":55,"contacts":144,"geoPoint":151},"Ascension St. Vincent","Indianapolis","Indiana","46240",[145,149],{"name":146,"role":59,"phone":147,"email":148},"Jena Stanley, BSN, RN, CCRN-K","317-583-6115","jena.stanley@ascension.org",{"name":150,"role":64},"Ezequiel Munoz, MD",{"lat":152,"lon":153},39.76838,-86.15804,{"facility":155,"status":7,"city":156,"state":157,"zip":158,"country":55,"contacts":159,"geoPoint":166},"Via Christi Regional Medical Center - St. Francis Campus","Wichita","Kansas","67214",[160,164],{"name":161,"role":59,"phone":162,"email":163},"Lindsey Steele","316-268-8092","lindsey.steele@ascension.org",{"name":165,"role":64},"Bassem Chehab, MD",{"lat":167,"lon":168},37.69224,-97.33754,{"facility":170,"status":7,"city":171,"state":172,"zip":173,"country":55,"contacts":174,"geoPoint":181},"Minneapolis Heart Institute","Minneapolis","Minnesota","55407",[175,179],{"name":176,"role":59,"phone":177,"email":178},"Jennifer Nguyen","612-863-9291","jennifer.nguyen@allina.com",{"name":180,"role":64},"Mario Goessl, MD",{"lat":182,"lon":183},44.97997,-93.26384,{"facility":185,"status":7,"city":186,"state":187,"zip":188,"country":55,"contacts":189,"geoPoint":196},"Providence St. Patrick Hospital","Missoula","Montana","59802",[190,194],{"name":191,"role":59,"phone":192,"email":193},"Hillary Lapham","406-327-1835","Hillary.Lapham@providence.org",{"name":195,"role":64},"Daniel Spoon, MD",{"lat":197,"lon":198},46.87215,-113.994,{"facility":200,"status":7,"city":201,"state":202,"zip":203,"country":55,"contacts":204,"geoPoint":211},"St. Francis Hospital","Roslyn","New York","11576",[205,209],{"name":206,"role":59,"phone":207,"email":208},"Elizabeth Haag, RN, BSN, CCRP","516-562-6790","Elizabeth.Haag@chsli.org",{"name":210,"role":64},"William Chung, MD",{"lat":212,"lon":213},40.79982,-73.65096,{"facility":215,"status":7,"city":216,"state":202,"zip":217,"country":55,"contacts":218,"geoPoint":224},"Montefiore Medical Center - Moses Campus","The Bronx","10467",[219,222],{"name":220,"role":59,"email":221},"Anna Wielgat","awielgat@montefiore.org",{"name":223,"role":64},"Andrea Scotti, MD",{"lat":225,"lon":226},40.84985,-73.86641,{"facility":228,"status":7,"city":229,"state":230,"zip":231,"country":55,"contacts":232,"geoPoint":239},"Atrium Health - Carolinas Medical Center","Charlotte","North Carolina","28203",[233,237],{"name":234,"role":59,"phone":235,"email":236},"ShaMal Brown","704-355-4691","shamal.brown@atriumhealth.org",{"name":238,"role":64},"Michael Rinaldi, MD",{"lat":240,"lon":241},35.22709,-80.84313,{"facility":243,"status":7,"city":244,"state":245,"zip":246,"country":55,"contacts":247,"geoPoint":254},"The Cleveland Clinic Foundation","Cleveland","Ohio","44195",[248,252],{"name":249,"role":59,"phone":250,"email":251},"Emilia Drenkhan","216-636-0776","drenkhe2@ccf.org",{"name":253,"role":64},"Amar Krishnaswamy, MD",{"lat":255,"lon":256},41.4995,-81.69541,{"facility":258,"status":7,"city":259,"state":260,"zip":261,"country":55,"contacts":262,"geoPoint":268},"Allegheny General Hospital - ASRI","Pittsburgh","Pennsylvania","15212",[263,266],{"name":264,"role":59,"email":265},"Kaylea Flick","Kaylea.Flick@ahn.org",{"name":267,"role":64},"Walter McGregor, MD",{"lat":269,"lon":270},40.44062,-79.99589,{"facility":272,"status":7,"city":273,"state":274,"zip":275,"country":55,"contacts":276,"geoPoint":283},"Medical University of South Carolina","Charleston","South Carolina","29425",[277,281],{"name":278,"role":59,"phone":279,"email":280},"Lauren Wakefield","843-876-5049","wakefila@musc.edu",{"name":282,"role":64},"Daniel Steinberg, MD",{"lat":284,"lon":285},32.77632,-79.93275,{"facility":287,"status":7,"city":288,"state":289,"zip":290,"country":55,"contacts":291,"geoPoint":297},"TriStar Centennial Medical Center","Nashville","Tennessee","37203",[292,295],{"name":293,"role":59,"email":294},"Taegan Vinarsky","taegan.vinarsky@hcahealthcare.com",{"name":296,"role":64},"Andrew Goodman, MD",{"lat":298,"lon":299},36.16589,-86.78444,{"facility":301,"status":7,"city":288,"state":289,"zip":302,"country":55,"contacts":303,"geoPoint":309},"Ascension Saint Thomas","37205",[304,307],{"name":305,"role":59,"email":306},"Sabrina Knight","sabrina.knight@ascension.org",{"name":308,"role":64},"Evelio Rodriguez, MD",{"lat":298,"lon":299},{"facility":311,"status":7,"city":288,"state":289,"zip":312,"country":55,"contacts":313,"geoPoint":319},"Vanderbilt Heart & Vascular Institute","37232",[314,317],{"name":315,"role":59,"email":316},"Kathryn Adams","kathy.adams@vumc.org",{"name":318,"role":64},"Kashish Goel, MD",{"lat":298,"lon":299},{"facility":321,"status":7,"city":322,"state":323,"zip":324,"country":55,"contacts":325,"geoPoint":331},"Houston Methodist","Houston","Texas","77030",[326,329],{"name":327,"role":59,"email":328},"Laticia Ellankil","lsellankil@houstonmethodist.org",{"name":330,"role":64},"Sachin Goel, MD",{"lat":332,"lon":333},29.76328,-95.36327,{"facility":335,"status":7,"city":322,"state":323,"zip":324,"country":55,"contacts":336,"geoPoint":343},"UTHealth Memorial Hermann",[337,341],{"name":338,"role":59,"phone":339,"email":340},"Angela Scott","713-486-6739","Angela.Scott@uth.tmc.edu",{"name":342,"role":64},"Biswajit Kar, MD",{"lat":332,"lon":333},{"facility":345,"status":7,"city":346,"state":347,"zip":348,"country":55,"contacts":349,"geoPoint":356},"Intermountain Medical Center","Murray","Utah","84107",[350,354],{"name":351,"role":59,"phone":352,"email":353},"Lindsay Bosh","801-917-0978","Lindsay.Bosh@imail.org",{"name":355,"role":64},"Brian Whisenant, MD",{"lat":357,"lon":358},40.66689,-111.88799,{"facility":360,"status":7,"city":361,"state":362,"zip":363,"country":55,"contacts":364,"geoPoint":371},"Sentara Norfolk General Hospital","Norfolk","Virginia","23507",[365,369],{"name":366,"role":59,"phone":367,"email":368},"Christine Calayo, RN","757-388-3876","cacalayo@sentara.com",{"name":370,"role":64},"Matthew Summers, MD",{"lat":372,"lon":373},36.84681,-76.28522,[375],{"name":376,"role":59,"phone":377,"email":378},"Cephea Project Manager","1+612.816.4605","cepheamvdregistry@abbott.com",[],[],[],{"nct_id":4,"conditions":383,"biomarkers":387},[384,385,386],"Mitral Valve Insufficiency","Mitral Valve Stenosis","Premature calcification of mitral annulus",[],{"nct_id":4,"found":389,"summary":390,"prompt_version":399},true,{"design":391,"status":392,"heading":6,"summary":393,"follow_up":394,"word_count":395,"commitments":396,"compensation":397,"drugs_mentioned":398},"This is an observational study that plans to enroll 1000 participants. It is not testing a specific intervention but rather collecting information about patients.","completed","This is a registry, which means it collects information about patients with mitral valve disease, including mitral regurgitation (a leaky heart valve), mitral stenosis (a narrowed heart valve), and mixed mitral valve disease. The goal is to better understand how treating these conditions affects patients, especially those who might receive a new treatment called Transcatheter Mitral Valve Replacement (TMVR) using the Cephea Mitral Valve System. You might be able to join if you are 18 or older, have symptomatic mitral valve disease, and your heart team believes TMVR is a good option for you. The study aims to gather data for up to two years after you enroll.","Participants will be followed from enrollment up to 2 years.",108,"Not specified in the trial record.","Not stated in the trial record.",[],"v2"]