[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100551873":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":24,"centralContacts":24,"locations":25,"responsibleParty":408,"collaborators":24,"id":410,"slug":411,"hasResults":412,"nctId":413,"briefTitle":414,"officialTitle":414,"acronym":24,"eligibilityCriteria":415,"healthyVolunteers":412,"sex":416,"minAge":417,"maxAge":24,"enrollmentInfo":418,"targetDuration":24,"studyType":421,"phases":422,"briefSummary":424,"conditions":425,"keywords":431,"overallStatus":28,"whyStopped":24,"lastUpdateSubmitDate":438,"lastUpdatePostDateStruct":439,"startDateStruct":442,"completionDateStruct":444,"leadSponsor":446,"locationsCount":447},{"fullName":5,"class":6},"4C Medical Technologies, Inc.","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Primary Cohort","EXPERIMENTAL","Designed to evaluate the safety and performance of the AltaValve System for the treatment of moderate-to-severe or severe MR in a targeted patient population without at least moderate mitral annular calcification (MAC).",[13],"Device: AltaValve System.",{"label":15,"type":10,"description":16,"interventionNames":17},"Mitral Annular Calcification Cohort (MAC)","Designed to evaluate the safety and performance of the AltaValve System for the treatment of moderate-to-severe or severe MR in a targeted patient population with moderate to severe MAC.",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"DEVICE","AltaValve System.","Transcatheter Mitral Valve Replacement.",[15,9],null,[26,45,55,67,81,94,109,123,136,150,162,176,189,208,221,235,248,261,275,289,303,316,327,338,349,362,373,386,397],{"facility":27,"status":28,"city":29,"state":30,"zip":31,"country":32,"countryCode":33,"cosmosGeoPoint":34,"geoPoint":39,"contacts":40},"Abrazo Arizona Heart Hospital","RECRUITING","Phoenix","Arizona","85016","United States","US",{"type":35,"coordinates":36},"Point",[37,38],-112.07404,33.44838,{"lat":38,"lon":37},[41],{"name":42,"role":43,"phone":44,"phoneExt":24,"email":24},"Principal Investigator","CONTACT","602-532-1000",{"facility":46,"status":28,"city":29,"state":30,"zip":47,"country":32,"countryCode":33,"cosmosGeoPoint":48,"geoPoint":50,"contacts":51},"Dignity Health; St. Joseph's Hospital and Medical Center","85032",{"type":35,"coordinates":49},[37,38],{"lat":38,"lon":37},[52],{"name":42,"role":43,"phone":53,"phoneExt":24,"email":54},"866-367-4373","DHRIAZ@DignityHealth.org",{"facility":56,"status":28,"city":57,"state":30,"zip":58,"country":32,"countryCode":33,"cosmosGeoPoint":59,"geoPoint":63,"contacts":64},"TMC Healthcare","Tucson","85712",{"type":35,"coordinates":60},[61,62],-110.92648,32.22174,{"lat":62,"lon":61},[65],{"name":42,"role":43,"phone":66,"phoneExt":24,"email":24},"520-327-5461",{"facility":68,"status":28,"city":69,"state":70,"zip":71,"country":32,"countryCode":33,"cosmosGeoPoint":72,"geoPoint":76,"contacts":77},"Sutter Bay Hospitals","San Francisco","California","94107",{"type":35,"coordinates":73},[74,75],-122.41942,37.77493,{"lat":75,"lon":74},[78],{"name":42,"role":43,"phone":79,"phoneExt":24,"email":80},"415-600-6000","milena.ferreira@sutterhealth.org",{"facility":82,"status":28,"city":83,"state":70,"zip":84,"country":32,"countryCode":33,"cosmosGeoPoint":85,"geoPoint":89,"contacts":90},"Los Robles Hospital & Medical Center","Thousand Oaks","91360",{"type":35,"coordinates":86},[87,88],-118.83759,34.17056,{"lat":88,"lon":87},[91],{"name":42,"role":43,"phone":92,"phoneExt":24,"email":93},"805-796-7836","Claire.Hozinsky@hcahealthcare.com",{"facility":95,"status":28,"city":96,"state":97,"zip":98,"country":32,"countryCode":33,"cosmosGeoPoint":99,"geoPoint":103,"contacts":104},"Cardiovascular Institute of the South","Houma","Louisiana","70360",{"type":35,"coordinates":100},[101,102],-90.71953,29.59577,{"lat":102,"lon":101},[105],{"name":106,"role":43,"phone":107,"phoneExt":24,"email":108},"Peter Fail, MD","985-876-0300","deanna.benoit@cardio.com",{"facility":110,"status":28,"city":111,"state":112,"zip":113,"country":32,"countryCode":33,"cosmosGeoPoint":114,"geoPoint":118,"contacts":119},"MedStar Health Research Institute, Inc.","Columbia","Maryland","21044",{"type":35,"coordinates":115},[116,117],-76.83942,39.24038,{"lat":117,"lon":116},[120],{"name":42,"role":43,"phone":121,"phoneExt":24,"email":122},"833-998-0900","JoinResearch@medstar.net",{"facility":124,"status":28,"city":125,"state":126,"zip":127,"country":32,"countryCode":33,"cosmosGeoPoint":128,"geoPoint":132,"contacts":133},"William Beaumont Hospital","Royal Oak","Michigan","48073",{"type":35,"coordinates":129},[130,131],-83.14465,42.48948,{"lat":131,"lon":130},[134],{"name":42,"role":43,"phone":135,"phoneExt":24,"email":24},"248-551-1235",{"facility":137,"status":28,"city":138,"state":139,"zip":140,"country":32,"countryCode":33,"cosmosGeoPoint":141,"geoPoint":145,"contacts":146},"Minneapolis Heart Institute Foundation","Minneapolis","Minnesota","55407",{"type":35,"coordinates":142},[143,144],-93.26384,44.97997,{"lat":144,"lon":143},[147],{"name":42,"role":43,"phone":148,"phoneExt":24,"email":149},"877-800-2729","info@mhif.org",{"facility":151,"status":28,"city":152,"state":139,"zip":153,"country":32,"countryCode":33,"cosmosGeoPoint":154,"geoPoint":158,"contacts":159},"Mayo Clinic","Rochester","55905",{"type":35,"coordinates":155},[156,157],-92.4699,44.02163,{"lat":157,"lon":156},[160],{"name":42,"role":43,"phone":161,"phoneExt":24,"email":24},"800-664-4542",{"facility":163,"status":28,"city":164,"state":165,"zip":166,"country":32,"countryCode":33,"cosmosGeoPoint":167,"geoPoint":171,"contacts":172},"Washington University","St Louis","Missouri","63110",{"type":35,"coordinates":168},[169,170],-90.19789,38.62727,{"lat":170,"lon":169},[173],{"name":42,"role":43,"phone":174,"phoneExt":24,"email":175},"314-747-6800","hrpo@wustl.edu",{"facility":177,"status":28,"city":178,"state":179,"zip":180,"country":32,"countryCode":33,"cosmosGeoPoint":181,"geoPoint":185,"contacts":186},"AHS Hospital Corp.","Morristown","New Jersey","07960",{"type":35,"coordinates":182},[183,184],-74.48154,40.79677,{"lat":184,"lon":183},[187],{"name":42,"role":43,"phone":188,"phoneExt":24,"email":24},"973-971-5000",{"facility":190,"status":191,"city":192,"state":192,"zip":193,"country":32,"countryCode":33,"cosmosGeoPoint":194,"geoPoint":198,"contacts":199},"New York Presbyterian Hospital-Columbia University Medical Center","NOT_YET_RECRUITING","New York","10032",{"type":35,"coordinates":195},[196,197],-74.00597,40.71427,{"lat":197,"lon":196},[200,204],{"name":201,"role":43,"phone":202,"phoneExt":24,"email":203},"Susheel Kodali","212-305-7060","sk2427@cumc.columbia.edu",{"name":205,"role":43,"phone":206,"phoneExt":24,"email":207},"Kate Dalton","(212) 305-7060","keb2114@cumc.columbia.edu",{"facility":209,"status":28,"city":210,"state":192,"zip":211,"country":32,"countryCode":33,"cosmosGeoPoint":212,"geoPoint":216,"contacts":217},"Montefiore Medical Center","The Bronx","10467",{"type":35,"coordinates":213},[214,215],-73.86641,40.84985,{"lat":215,"lon":214},[218],{"name":42,"role":43,"phone":219,"phoneExt":24,"email":220},"718-920-2000","oct@montefiore.org",{"facility":222,"status":28,"city":223,"state":224,"zip":225,"country":32,"countryCode":33,"cosmosGeoPoint":226,"geoPoint":230,"contacts":231},"The Charlotte-Mecklenburg Hospital; Atrium Health","Charlotte","North Carolina","28203",{"type":35,"coordinates":227},[228,229],-80.84313,35.22709,{"lat":229,"lon":228},[232],{"name":42,"role":43,"phone":233,"phoneExt":24,"email":234},"800-821-1535","IRBInfo@AtriumHealth.org",{"facility":236,"status":28,"city":237,"state":238,"zip":239,"country":32,"countryCode":33,"cosmosGeoPoint":240,"geoPoint":244,"contacts":245},"University Hospitals Cleveland Medical Center","Cleveland","Ohio","44106",{"type":35,"coordinates":241},[242,243],-81.69541,41.4995,{"lat":243,"lon":242},[246],{"name":42,"role":43,"phone":247,"phoneExt":24,"email":24},"833-788-7425",{"facility":249,"status":28,"city":250,"state":251,"zip":252,"country":32,"countryCode":33,"cosmosGeoPoint":253,"geoPoint":257,"contacts":258},"South Oklahoma Heart Research, LLC.","Oklahoma City","Oklahoma","73135",{"type":35,"coordinates":254},[255,256],-97.51643,35.46756,{"lat":256,"lon":255},[259],{"name":42,"role":43,"phone":260,"phoneExt":24,"email":24},"405-628-6000",{"facility":262,"status":28,"city":263,"state":264,"zip":265,"country":32,"countryCode":33,"cosmosGeoPoint":266,"geoPoint":270,"contacts":271},"Oregon Health & Science University","Portland","Oregon","97239",{"type":35,"coordinates":267},[268,269],-122.67621,45.52345,{"lat":269,"lon":268},[272],{"name":42,"role":43,"phone":273,"phoneExt":24,"email":274},"503-346-0811","octrirecruitment@ohsu.edu",{"facility":276,"status":28,"city":277,"state":278,"zip":279,"country":32,"countryCode":33,"cosmosGeoPoint":280,"geoPoint":284,"contacts":285},"The University of Texas Health Science Center at Houston","Houston","Texas","77030",{"type":35,"coordinates":281},[282,283],-95.36327,29.76328,{"lat":283,"lon":282},[286],{"name":42,"role":43,"phone":287,"phoneExt":24,"email":288},"713-500-3622","clinicaltrials@uth.tmc.edu",{"facility":290,"status":28,"city":291,"state":292,"zip":293,"country":32,"countryCode":33,"cosmosGeoPoint":294,"geoPoint":298,"contacts":299},"University of Virginia","Charlottesville","Virginia","22903",{"type":35,"coordinates":295},[296,297],-78.47668,38.02931,{"lat":297,"lon":296},[300],{"name":42,"role":43,"phone":301,"phoneExt":24,"email":302},"434-924-3606","jgd7s@uvahealth.org",{"facility":304,"status":28,"city":305,"state":24,"zip":24,"country":306,"countryCode":307,"cosmosGeoPoint":308,"geoPoint":312,"contacts":313},"Universitatsklinikum Bonn","Bonn","Germany","DE",{"type":35,"coordinates":309},[310,311],7.09549,50.73438,{"lat":311,"lon":310},[314],{"name":42,"role":43,"phone":315,"phoneExt":24,"email":24},"+49 170-3750855",{"facility":317,"status":28,"city":318,"state":24,"zip":24,"country":306,"countryCode":307,"cosmosGeoPoint":319,"geoPoint":323,"contacts":324},"University Hospital Cologne - Heart Center","Cologne",{"type":35,"coordinates":320},[321,322],6.95,50.93333,{"lat":322,"lon":321},[325],{"name":42,"role":43,"phone":326,"phoneExt":24,"email":24},"+49 221 478-0",{"facility":328,"status":28,"city":329,"state":24,"zip":24,"country":306,"countryCode":307,"cosmosGeoPoint":330,"geoPoint":334,"contacts":335},"Cardiac Research GmbH; St.-Johannes-Hospital Dortmund","Dortmund",{"type":35,"coordinates":331},[332,333],7.466,51.51494,{"lat":333,"lon":332},[336],{"name":42,"role":43,"phone":337,"phoneExt":24,"email":24},"+49 0231.952 971-0",{"facility":339,"status":28,"city":340,"state":24,"zip":24,"country":306,"countryCode":307,"cosmosGeoPoint":341,"geoPoint":345,"contacts":346},"Heart Center Trier","Trier",{"type":35,"coordinates":342},[343,344],6.63935,49.75565,{"lat":344,"lon":343},[347],{"name":42,"role":43,"phone":348,"phoneExt":24,"email":24},"+49 (0)651 97544-0",{"facility":350,"status":28,"city":351,"state":24,"zip":24,"country":352,"countryCode":353,"cosmosGeoPoint":354,"geoPoint":358,"contacts":359},"Onassis Cardiac Surgery Center","Athens","Greece","GR",{"type":35,"coordinates":355},[356,357],23.72784,37.98376,{"lat":357,"lon":356},[360],{"name":42,"role":43,"phone":361,"phoneExt":24,"email":24},"+30 21 0949 3000",{"facility":363,"status":28,"city":364,"state":24,"zip":24,"country":352,"countryCode":353,"cosmosGeoPoint":365,"geoPoint":369,"contacts":370},"Interbalkan Medical Center of Thessaloniki","Thessaloniki",{"type":35,"coordinates":366},[367,368],22.93493,40.64072,{"lat":368,"lon":367},[371],{"name":42,"role":43,"phone":372,"phoneExt":24,"email":24},"+30 231 040 0000",{"facility":374,"status":28,"city":375,"state":24,"zip":24,"country":376,"countryCode":377,"cosmosGeoPoint":378,"geoPoint":382,"contacts":383},"Hospital Clinic de Barcelona","Barcelona","Spain","ES",{"type":35,"coordinates":379},[380,381],2.15899,41.38879,{"lat":381,"lon":380},[384],{"name":42,"role":43,"phone":385,"phoneExt":24,"email":24},"+34 932 27 54 00",{"facility":387,"status":28,"city":388,"state":24,"zip":24,"country":376,"countryCode":377,"cosmosGeoPoint":389,"geoPoint":393,"contacts":394},"Fundación para la investigación biomédica del hospital clínico San Carlos","Madrid",{"type":35,"coordinates":390},[391,392],-3.70256,40.4165,{"lat":392,"lon":391},[395],{"name":42,"role":43,"phone":396,"phoneExt":24,"email":24},"+34 913 30 37 93",{"facility":398,"status":28,"city":399,"state":24,"zip":24,"country":376,"countryCode":377,"cosmosGeoPoint":400,"geoPoint":404,"contacts":405},"Hospital Álvaro Cunqueiro","Vigo",{"type":35,"coordinates":401},[402,403],-8.72264,42.23282,{"lat":403,"lon":402},[406],{"name":42,"role":43,"phone":407,"phoneExt":24,"email":24},"+34 986 81 11 11",{"type":409,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR","100551873","altavalve-pivotal-trial-100551873",false,"NCT06465745","AltaValve Pivotal Trial","Inclusion Criteria:\n\n* Age ≥ 18 years.\n* Symptomatic New York Heart Association (NYHA) class II-IV.\n* Moderate-to-severe or severe MR (3+) despite optimal guideline-directed medical therapy (GDMT) as determined by an independent Echo Core Lab.\n* Unsuitable for surgery and Transcatheter Edge-toEdge Repair (TEER) as determined by the local site Heart Team.\n\nExclusion Criteria (Abbreviated List):\n\n* Inability to understand the trial or a history of non-compliance with medical advice.\n* Inability to provide signed Informed Consent Form (ICF).\n* History of any cognitive or mental health status that would interfere with participation in the trial.\n* Currently enrolled in any other pre-approval investigational trial (does not apply to long-term post-market trials unless these trials might clinically interfere with the current trial endpoints (e.g., limit use of trial-required medication, etc.)).\n* Female subjects who are pregnant or planning to become pregnant within the trial period.\n* Known hypersensitivity or contraindication to heparin, or warfarin without adequate alternative medications.\n* Known hypersensitivity to nitinol (i.e., nickel allergy) that cannot be adequately medicated.\n* Known hypersensitivity to contrast media that cannot be adequately medicated.\n* Evidence of current left ventricular ejection fraction (LVEF) ≤ 25%.\n* Concurrent medical condition with a life expectancy of less than 12 months.\n* Transcatheter aortic repair or replacement within 90 days prior to the index procedure.\n* Percutaneous coronary intervention (PCI) within 90 days prior to the index procedure.","ALL","18 Years",{"count":419,"type":420},450,"ESTIMATED","INTERVENTIONAL",[423],"NA","This is a prospective, single arm, multicenter, clinical trial designed to evaluate the safety and performance of the AltaValve System for the treatment of mitral regurgitation in a targeted patient population.",[426,427,428,429,430],"Mitral Regurgitation","Mitral Insufficiency","Mitral Valve Incompetence","Mitral Valve Regurgitation","Mitral Incompetence",[426,432,433,434,435,436,437],"TMVR","Functional Regurgitation","Degenerative Regurgitation","Transcatheter Mitral Valve Replacement","Primary Regurgitation","Secondary Regurgitation","2025-04-30",{"date":440,"type":441},"2025-05-02","ACTUAL",{"date":443,"type":441},"2024-09-03",{"date":445,"type":420},"2031-09",{"name":5,"class":6},29]