[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100420927":3},{"organization":4,"armGroups":7,"interventions":33,"overallOfficials":51,"centralContacts":56,"locations":66,"responsibleParty":283,"collaborators":10,"id":285,"slug":286,"hasResults":287,"nctId":288,"briefTitle":289,"officialTitle":290,"acronym":291,"eligibilityCriteria":292,"healthyVolunteers":287,"sex":293,"minAge":294,"maxAge":10,"enrollmentInfo":295,"targetDuration":10,"studyType":298,"phases":10,"briefSummary":299,"conditions":300,"keywords":304,"overallStatus":93,"whyStopped":10,"lastUpdateSubmitDate":313,"lastUpdatePostDateStruct":314,"startDateStruct":317,"completionDateStruct":319,"leadSponsor":321,"locationsCount":322},{"fullName":5,"class":6},"Abbott Medical Devices","INDUSTRY",[8,16,20,24,28],{"label":9,"type":10,"description":11,"interventionNames":12},"Group 1: Primary mitral disease repair surgery with an Abbott annuloplasty ring implant",null,"Group 1 will enroll 200 subjects undergoing surgical repair of primary mitral regurgitation that includes annuloplasty with an Abbott SJM Rigid Saddle Ring, Séguin Ring or full Tailor Ring without cut zone removal. Enrollment must include at least 50 subjects implanted with each ring model. In primary mitral regurgitation, backflow through the closed valve is caused by disease intrinsic to the mitral valve tissue itself.",[13,14,15],"Device: Abbott SJM Rigid Saddle Ring","Device: Abbott SJM Séguin Ring","Device: Abbott SJM Tailor Ring",{"label":17,"type":10,"description":18,"interventionNames":19},"Group 2: Secondary mitral disease repair surgery with an Abbott annuloplasty ring implant","Group 2 will enroll 200 subjects undergoing surgical repair of secondary mitral regurgitation that includes annuloplasty with an Abbott SJM Rigid Saddle Ring, Séguin Ring or full Tailor Ring without cut zone removal. Enrollment must include at least 50 subjects implanted with each ring model. In secondary mitral regurgitation, backflow through the closed valve is secondary to diseases of the surrounding myocardium, rather than caused by disease of the valve tissue itself.",[13,14,15],{"label":21,"type":10,"description":22,"interventionNames":23},"Group 3: Primary tricuspid disease repair surgery with a full Tailor Ring implant","Group 3 will enroll up to 50 subjects undergoing surgical repair of primary tricuspid regurgitation that includes annuloplasty with a full Abbott SJM Tailor Ring without cut zone removal. In primary tricuspid regurgitation, backflow through the closed valve is caused by disease intrinsic to the tricuspid valve tissue itself.",[15],{"label":25,"type":10,"description":26,"interventionNames":27},"Group 4: Secondary tricuspid disease repair surgery with a full Tailor Ring implant","Group 4 will enroll up to 50 subjects undergoing surgical repair of secondary tricuspid regurgitation that includes annuloplasty with a full Abbott SJM Tailor Ring without cut zone removal. In secondary tricuspid regurgitation, backflow through the closed valve is secondary to diseases of the surrounding myocardium, rather than caused by disease of the valve tissue itself.",[15],{"label":29,"type":10,"description":30,"interventionNames":31},"Group 5: Primary tricuspid disease repair surgery with a partial Tailor Ring or Tailor Band implant","Group 4 will enroll up to 50 subjects undergoing surgical repair of secondary tricuspid regurgitation that includes posterior annuloplasty with either a partial Abbott SJM Tailor Ring with cut zone removed or an Abbott SJM Tailor Band. In primary tricuspid regurgitation, backflow through the closed valve is caused by disease intrinsic to the tricuspid valve tissue itself.",[15,32],"Device: Abbott SJM Tailor Band",[34,39,43,47],{"type":35,"name":36,"description":37,"armGroupLabels":38,"otherNames":10},"DEVICE","Abbott SJM Rigid Saddle Ring","The Abbott SJM Rigid Saddle Ring is a rigid, polyester-velour-covered, titanium alloy mitral annuloplasty ring with a saddle shape intended to mimic the shape of a healthy mitral annulus during systole.",[9,17],{"type":35,"name":40,"description":41,"armGroupLabels":42,"otherNames":10},"Abbott SJM Séguin Ring","The Abbott SJM Séguin Ring is a semi-rigid, polyester-velour-covered, polyethylene mitral annuloplasty ring that varies in thickness and flexibility over its circumference, with the posterior portion of the ring having greater flexibility than the anterior portion.",[9,17],{"type":35,"name":44,"description":45,"armGroupLabels":46,"otherNames":10},"Abbott SJM Tailor Ring","The Abbott SJM Tailor Ring is a flexible, polyester-velour-covered, silicone annuloplasty ring indicated for use in surgical repair of the mitral or tricuspid valve. The Tailor Ring can be implanted as a full annuloplasty ring, or the surgeon can remove the ring's cut zone with a scalpel and use the partial Tailor Ring as a posterior annuloplasty band.",[9,17,21,25,29],{"type":35,"name":48,"description":49,"armGroupLabels":50,"otherNames":10},"Abbott SJM Tailor Band","The Abbott SJM Tailor Band is a flexible, polyester-velour-covered, silicone band for posterior annuloplasty indicated for use in surgical repair of mitral or tricuspid valve. The Tailor Band is identical to the Tailor Ring with the cut zone removed, save that the polyester covering is sewn closed at the ends of the band during manufacturing.",[29],[52],{"name":53,"affiliation":54,"role":55},"Ryan Palmer","Abbott","STUDY_DIRECTOR",[57,62],{"name":58,"role":59,"phone":60,"phoneExt":10,"email":61},"Karine Miquel","CONTACT","+32 479 60 01 07","karine.miquel@abbott.com",{"name":63,"role":59,"phone":64,"phoneExt":10,"email":65},"Leslie Ornelas","+14803067436","leslie.ornelas@abbott.com",[67,81,91,106,121,134,149,159,172,185,198,212,225,235,240,253,268],{"facility":68,"status":69,"city":70,"state":71,"zip":72,"country":73,"countryCode":74,"cosmosGeoPoint":75,"geoPoint":80,"contacts":10},"Duke University Hospital","WITHDRAWN","Durham","North Carolina","27710","United States","US",{"type":76,"coordinates":77},"Point",[78,79],-78.89862,35.99403,{"lat":79,"lon":78},{"facility":82,"status":69,"city":83,"state":84,"zip":85,"country":73,"countryCode":74,"cosmosGeoPoint":86,"geoPoint":90,"contacts":10},"University of Wisconsin Hospital and Clinics","Madison","Wisconsin","53792",{"type":76,"coordinates":87},[88,89],-89.40123,43.07305,{"lat":89,"lon":88},{"facility":92,"status":93,"city":94,"state":10,"zip":95,"country":96,"countryCode":97,"cosmosGeoPoint":98,"geoPoint":102,"contacts":103},"Tartu University Hospital","RECRUITING","Tartu","50406","Estonia","EE",{"type":76,"coordinates":99},[100,101],26.72509,58.38062,{"lat":101,"lon":100},[104],{"name":105,"role":59,"phone":10,"phoneExt":10,"email":10},"Prof Arno Ruusalepp, PhD",{"facility":107,"status":93,"city":108,"state":109,"zip":110,"country":111,"countryCode":112,"cosmosGeoPoint":113,"geoPoint":117,"contacts":118},"Hopital Cardiovasculaire et Pneumologique Louis Pradel","Lyon","Auvergne-Rhône-Alpes","69500","France","FR",{"type":76,"coordinates":114},[115,116],4.84789,45.74906,{"lat":116,"lon":115},[119],{"name":120,"role":59,"phone":10,"phoneExt":10,"email":10},"Prof Jean-François Obadia, MD",{"facility":122,"status":93,"city":123,"state":124,"zip":125,"country":111,"countryCode":112,"cosmosGeoPoint":126,"geoPoint":130,"contacts":131},"CHU de Besançon - Jean Minjoz","Besançon","Bourgogne-Franche-Comté","25000",{"type":76,"coordinates":127},[128,129],6.01815,47.24878,{"lat":129,"lon":128},[132],{"name":133,"role":59,"phone":10,"phoneExt":10,"email":10},"Dr Sidney Chocron, MD",{"facility":135,"status":93,"city":136,"state":137,"zip":138,"country":139,"countryCode":140,"cosmosGeoPoint":141,"geoPoint":145,"contacts":146},"Herzchirurgische Abteilung Klinikum Passau","Passau","Bavaria","94032","Germany","DE",{"type":76,"coordinates":142},[143,144],13.43122,48.5665,{"lat":144,"lon":143},[147],{"name":148,"role":59,"phone":10,"phoneExt":10,"email":10},"Dr. Markus Czesla, MD",{"facility":150,"status":151,"city":152,"state":137,"zip":153,"country":139,"countryCode":140,"cosmosGeoPoint":154,"geoPoint":158,"contacts":10},"Universitätsklinikum Würzburg","COMPLETED","Würzburg","97080",{"type":76,"coordinates":155},[156,157],9.95121,49.79391,{"lat":157,"lon":156},{"facility":160,"status":93,"city":161,"state":162,"zip":163,"country":139,"countryCode":140,"cosmosGeoPoint":164,"geoPoint":168,"contacts":169},"Herzzentrum-Bremen Klinikum Links der Weser","Bremen","Free Hanseatic City of Bremen","28211",{"type":76,"coordinates":165},[166,167],8.80717,53.07582,{"lat":167,"lon":166},[170],{"name":171,"role":59,"phone":10,"phoneExt":10,"email":10},"Dr Thorsten Schmidt, MD",{"facility":173,"status":93,"city":174,"state":175,"zip":176,"country":139,"countryCode":140,"cosmosGeoPoint":177,"geoPoint":181,"contacts":182},"Herzzentrum Dresden, Universitätsklinik an der Technischen Universität Dresden","Dresden","Saxony","01307",{"type":76,"coordinates":178},[179,180],13.73832,51.05089,{"lat":180,"lon":179},[183],{"name":184,"role":59,"phone":10,"phoneExt":10,"email":10},"Prof. Dr. Klaus Matschke, MD, PhD",{"facility":186,"status":93,"city":187,"state":188,"zip":189,"country":139,"countryCode":140,"cosmosGeoPoint":190,"geoPoint":194,"contacts":195},"Universitätsklinikum Jena","Jena","Thuringia","07740",{"type":76,"coordinates":191},[192,193],11.5899,50.92878,{"lat":193,"lon":192},[196],{"name":197,"role":59,"phone":10,"phoneExt":10,"email":10},"Prof. Dr. Torsten Doenst, MD, PhD",{"facility":199,"status":93,"city":200,"state":200,"zip":201,"country":202,"countryCode":203,"cosmosGeoPoint":204,"geoPoint":208,"contacts":209},"Policlinico S.Orsola-Malpighi","Bologna","40138","Italy","IT",{"type":76,"coordinates":205},[206,207],11.33875,44.49381,{"lat":207,"lon":206},[210],{"name":211,"role":59,"phone":10,"phoneExt":10,"email":10},"Prof Davide Pacini, MD",{"facility":213,"status":93,"city":214,"state":215,"zip":216,"country":202,"countryCode":203,"cosmosGeoPoint":217,"geoPoint":221,"contacts":222},"Ospedale San Raffaele - Cardiac","Milan","Lombardy","1350",{"type":76,"coordinates":218},[219,220],9.18951,45.46427,{"lat":220,"lon":219},[223],{"name":224,"role":59,"phone":10,"phoneExt":10,"email":10},"Prof. Michele De Bonis, MD",{"facility":226,"status":93,"city":214,"state":227,"zip":228,"country":202,"countryCode":203,"cosmosGeoPoint":229,"geoPoint":231,"contacts":232},"Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico","Lombard","20157",{"type":76,"coordinates":230},[219,220],{"lat":220,"lon":219},[233],{"name":234,"role":59,"phone":10,"phoneExt":10,"email":10},"Prof Carlo Antona, MDA",{"facility":236,"status":69,"city":214,"state":214,"zip":228,"country":202,"countryCode":203,"cosmosGeoPoint":237,"geoPoint":239,"contacts":10},"Ospedale Luigi Sacco",{"type":76,"coordinates":238},[219,220],{"lat":220,"lon":219},{"facility":241,"status":93,"city":242,"state":243,"zip":244,"country":202,"countryCode":203,"cosmosGeoPoint":245,"geoPoint":249,"contacts":250},"Ospedale Umberto I","Turin","Piedmont","10128",{"type":76,"coordinates":246},[247,248],7.68682,45.07049,{"lat":248,"lon":247},[251],{"name":252,"role":59,"phone":10,"phoneExt":10,"email":10},"Dr Paolo Centofanti, MD",{"facility":254,"status":93,"city":255,"state":256,"zip":257,"country":258,"countryCode":259,"cosmosGeoPoint":260,"geoPoint":264,"contacts":265},"Catharina Ziekenhuis","Eindhoven","North Brabant","5623 EJ","Netherlands","NL",{"type":76,"coordinates":261},[262,263],5.47778,51.44083,{"lat":263,"lon":262},[266],{"name":267,"role":59,"phone":10,"phoneExt":10,"email":10},"Dr Andrew Tjon, MD",{"facility":269,"status":93,"city":270,"state":271,"zip":272,"country":273,"countryCode":274,"cosmosGeoPoint":275,"geoPoint":279,"contacts":280},"Hospital Alvaro Cunqueiro","Vigo","Pontevedra","36312","Spain","ES",{"type":76,"coordinates":276},[277,278],-8.72264,42.23282,{"lat":278,"lon":277},[281],{"name":282,"role":59,"phone":10,"phoneExt":10,"email":10},"Dr Juan José Legarra, MD",{"type":284,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100420927","annuloplasty-rings-and-band-post-market-clinical-follow-up-study-100420927",false,"NCT04761120","Annuloplasty Rings and Band Post-Market Clinical Follow-Up Study","Annuloplasty Rings and Band Post-Market Clinical Follow-Up (ARB-PMCF) Study","ARB-PMCF","Inclusion Criteria:\n\n1. Subject is expected to undergo cardiac surgery in ≤90 days including at least one of the following:\n\n   1. implant of a Rigid Saddle Ring, Séguin Ring or a full Tailor Ring without cut zone removal for MR repair\n   2. implant of a full Tailor Ring without cut zone removal for TR repair, or\n   3. implant of a Tailor Band or partial Tailor Ring with cut zone removed for primary TR repair.\n2. Subject's cardiac surgery will be performed by a study investigator.\n3. Subject will be ≥18 years old at the time of their annuloplasty implant(s).\n4. Subject provides written informed consent and agrees to comply with all required study visits and procedures.\n\nExclusion Criteria:\n\n1. Subject is below the age of legal consent in the applicable jurisdiction or otherwise lacks legal authority to provide informed consent.\n2. Subject is unable to read or write or has a mental illness or disability that impairs their ability to provide written informed consent.\n3. Subject is expected to have active endocarditis at the time of their Abbott annuloplasty device implant(s).\n4. Subject cannot be unambiguously assigned to a treatment group due to missing data on repair indication(s) or the model and configuration (cut zone removed or not) of their Abbott annuloplasty implant(s).\n5. Subject is participating in another clinical investigation including any treatment outside the investigative site's usual standard of care.\n6. Subject has anomalous anatomy or medical, surgical, psychiatric or social history or conditions that, in the investigator's opinion, would limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements","ALL","18 Years",{"count":296,"type":297},550,"ESTIMATED","OBSERVATIONAL","ARB-PMCF is a multicenter, observational study of the safety and performance of Abbott annuloplasty devices used in surgical repair of mitral and tricuspid valve regurgitation. The devices included in this study are the SJM™ Rigid Saddle Ring and SJM Séguin Annuloplasty Ring, indicated for mitral valve repair, and the SJM Tailor™ Annuloplasty Ring and SJM Tailor Annuloplasty Band, indicated for mitral or tricuspid repair. Participants will be enrolled prior to undergoing mitral or tricuspid valve repair surgery including an Abbott annuloplasty implant and will complete annual follow-up visits through five years from implant. The study is being conducted to meet post-market clinical follow-up requirements of the European Union Medical Device Directives.",[301,302,303],"Mitral Regurgitation","Tricuspid Regurgitation","Valvular Heart Disease",[301,302,305,306,307,308,309,310,311,312],"Valve Surgery","Valve Repair","Annuloplasty Rings","Annuloplasty Bands","Rigid Saddle Ring","Séguin Annuloplasty Ring","Tailor Annuloplasty Ring","Tailor Annuloplasty Band","2026-05-14",{"date":315,"type":316},"2026-05-18","ACTUAL",{"date":318,"type":316},"2021-02-01",{"date":320,"type":297},"2031-03",{"name":5,"class":6},17]