[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100558951":3},{"organization":4,"outcomesModule":7,"designInfo":67,"detailedDescription":70,"studyPopulation":71,"armGroups":72,"interventions":88,"overallOfficials":102,"centralContacts":107,"locations":117,"responsibleParty":730,"collaborators":732,"id":738,"slug":739,"hasResults":740,"nctId":741,"briefTitle":742,"officialTitle":743,"acronym":744,"eligibilityCriteria":745,"healthyVolunteers":740,"sex":746,"minAge":747,"maxAge":66,"enrollmentInfo":748,"targetDuration":66,"studyType":751,"phases":66,"briefSummary":752,"conditions":753,"keywords":755,"overallStatus":120,"whyStopped":66,"lastUpdateSubmitDate":757,"lastUpdatePostDateStruct":758,"startDateStruct":761,"completionDateStruct":763,"leadSponsor":765,"locationsCount":766},{"fullName":5,"class":6},"The Leeds Teaching Hospitals NHS Trust","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":24,"otherOutcomes":66},[9,13,17,20,22],{"measure":10,"description":11,"timeFrame":12},"REVALVE success (Redo TAVI)","Correct positioning of a single prosthetic heart valve into the proper anatomic location, intended performance of the valve (mean gradient \\\u003C20mmHg, peak velocity \\\u003C3 m\u002Fs, Doppler velocity index ≥0.25. aortic regurgitation \\\u003C moderate), Freedom from mortality, coronary obstruction, unplanned coronary revascularisation, surgery or intervention related to the device","30 days",{"measure":14,"description":15,"timeFrame":16},"Freedom from death\u002Fstroke\u002Fre-hospitalisation for valve or procedure-related causes (Redo TAVI)","Composite outcome of freedom from death\u002Fstroke\u002Fre-hospitalisation for valve or procedure-related causes","12 months",{"measure":18,"description":19,"timeFrame":12},"Valve Academic Research Consortium 3 (VARC3) Early Safety (EXPLANT)","Composite outcome of freedom from: death\u002Fstroke\u002FVARC 3-4 bleeding\u002Fmajor vascular, access-related, or cardiac structural complication\u002FAKI 3 or 4\u002Fmoderate or severe AR\u002Fnew permanent pacemaker\u002Fdevice-related surgery or intervention",{"measure":21,"description":15,"timeFrame":16},"Freedom from death\u002Fstroke\u002Fre-hospitalisation for valve or procedure-related causes (EXPLANT)",{"measure":23,"description":15,"timeFrame":16},"Freedom from death\u002Fstroke\u002Fre-hospitalisation for valve or procedure-related causes (OMT)",[25,29,32,35,38,42,46,49,52,56,59,62],{"measure":26,"description":27,"timeFrame":28},"Valve Academic Research Consortium 3 (VARC3) Technical Success (Redo TAVI and EXPLANT)","Freedom from mortality, successful access, delivery of the device, and retrieval of the delivery system, correct positioning of a single prosthetic heart valve into the proper anatomical location, freedom from surgery or intervention related to the device or to a major vascular or access-related, or cardiac structural complication","End of procedure",{"measure":30,"description":31,"timeFrame":12},"Valve Academic Research Consortium 3 (VARC3) Device Success (Redo TAVI and EXPLANT)","Technical success, Freedom from mortality, Freedom from surgery or intervention related to the device, or to a major vascular or access-related or cardiac structural complication, Intended performance of the valve (mean gradient \\\u003C20 mmHg, peak velocity \\\u003C3 m\u002Fs, Doppler velocity index ≥0.25, aortic regurgitation \\\u003C moderate)",{"measure":33,"description":34,"timeFrame":12},"Valve Academic Research Consortium 3 (VARC3) Early Safety (Redo TAVI)","Freedom from: death\u002Fstroke\u002FVARC 2-4 bleeding (only VARC 3-4 for EXPLANT) \u002Fmajor vascular, access-related, or cardiac structural complication\u002FAcute kidney injury (AKI) 3 or 4\u002Fmoderate or severe Aortic Regurgitation\u002Fnew permanent pacemaker\u002Fdevice-related surgery or intervention",{"measure":36,"description":37,"timeFrame":28},"Peak and mean invasive gradient post-procedure (Redo TAVI)","Invasive pressure measurements",{"measure":39,"description":40,"timeFrame":41},"In-hospital Clinical Outcomes","All-cause mortality; All stroke; Myocardial infarction; Coronary artery obstruction; Unplanned coronary revascularisation (PCI or CABG); Bleeding (VARC 1-4); Major or minor Vascular and access-related complications; Cardiac structural complications; Permanent pacemaker implantation; Acute kidney injury (AKI) stage 1-4; Endocarditis; Clinically significant valve thrombosis","Immediately after the procedure\u002Fsurgery",{"measure":43,"description":44,"timeFrame":45},"Echocardiographic Assessment: Peak velocity","Peak velocity","Pre-discharge or at 30 days, 1, 3, 5 years",{"measure":47,"description":48,"timeFrame":45},"Echocardiographic Assessment: Mean gradient","Mean gradient",{"measure":50,"description":51,"timeFrame":45},"Echocardiographic Assessment: Aortic valve area","Aortic valve area",{"measure":53,"description":54,"timeFrame":55},"Echocardiographic Assessment: Patient-prosthesis mismatch","Patient-prosthesis mismatch","Pre-discharge or at 30 days",{"measure":57,"description":58,"timeFrame":45},"Echocardiographic Assessment: Aortic Regurgitation - paravalvular, transvalvular or total","Aortic Regurgitation - paravalvular, transvalvular or total",{"measure":60,"description":61,"timeFrame":45},"Echocardiographic Assessment: Left ventricular systolic function","Left ventricular systolic function",{"measure":63,"description":64,"timeFrame":65},"Clinical Outcomes","All-cause mortality; Cardiovascular mortality; Valve-related mortality; Hospitalisation; Cardiovascular hospitalisation; Hospitalisation for valve or procedure-related causes; All stroke; Myocardial infarction; Coronary angiography; Coronary revascularization; Bioprosthetic valve dysfunction: i. Structural valve deterioration; ii. Non-structural valve deterioration (Prosthesis-patient mismatch, Paravalvular aortic regurgitation, Other) iii. Thrombosis iv. Endocarditis; Bioprosthetic valve failure; Aortic valve re-intervention","1, 3 and 5 years",null,{"allocation":66,"interventionModel":66,"interventionModelDescription":66,"primaryPurpose":66,"observationalModel":68,"timePerspective":69,"maskingInfo":66},"COHORT","PROSPECTIVE","To determine the acute and long-term outcomes of Redo Transcatheter Aortic Valve Implantation (TAVI) for the treatment of Bioprosthetic Valve Failure (BVF) affecting Transcatheter Aortic Heart Valves (THVs)\n\nTo determine the factors which predict the acute and long-term outcomes of Redo TAVI\n\nTo determine the proportion of patients presenting with BVF affecting THVs who are deemed unsuitable for Redo TAVI by the Heart Team\n\nTo determine the acute and long-term outcomes of surgical explantation and aortic valve replacement (AVR) for the treatment of BVF affecting THVs\n\nTo determine the survival of patients presenting with BVF affecting THVs who are managed conservatively - including optimal medical therapy (OMT) +\u002F- balloon aortic valvuloplasty (BAV)","All patients presenting to the Heart Team with bio-prosthetic valve failure affecting a transcatheter aortic valve",[73,78,83],{"label":74,"type":66,"description":75,"interventionNames":76},"Redo TAVI","Redo Trans-catheter Aortic Valve Implantation for Bioprosthetic Valve Failure of a Trans-catheter Aortic Valve",[77],"Device: Any commercially available Edwards or Medtronic transcatheter aortic valve with the TAV-in-TAV (Redo TAVI) indication",{"label":79,"type":66,"description":80,"interventionNames":81},"Explant","Surgical explantation with aortic valve replacement",[82],"Procedure: Surgical explantation and aortic valve replacement",{"label":84,"type":66,"description":85,"interventionNames":86},"Optimal Medical Therapy","Conservative treatment, including optimal medical therapy +\u002F- balloon aortic valvuloplasty",[87],"Other: Conservative management",[89,94,99],{"type":90,"name":91,"description":92,"armGroupLabels":93,"otherNames":66},"DEVICE","Any commercially available Edwards or Medtronic transcatheter aortic valve with the TAV-in-TAV (Redo TAVI) indication","Redo TAVI will be performed using any commercially available Edwards or Medtronic transcatheter aortic valve platforms that have the TAV-in-TAV (Redo TAVI) indication according to the preferences of the local team in keeping with standard clinical care.",[74],{"type":95,"name":96,"description":97,"armGroupLabels":98,"otherNames":66},"PROCEDURE","Surgical explantation and aortic valve replacement","Surgical explantation of all or part of the index transcatheter aortic valve, with open implantation of a new surgical or transcatheter aortic valve replacement will be performed according to the preferences of the local team in keeping with standard clinical care. Any commercially available approved surgical or transcatheter aortic valve may be used. Additional surgery, such as aortic root replacement, root enlargement, CABG, mitral valve repair\u002Freplacement, etc. will be performed at the discretion of the local team.",[79],{"type":6,"name":100,"description":85,"armGroupLabels":101,"otherNames":66},"Conservative management",[84],[103],{"name":104,"affiliation":105,"role":106},"Daniel Blackman, MD","Leeds Teaching Hospitals NHS Trust","PRINCIPAL_INVESTIGATOR",[108,113],{"name":109,"role":110,"phone":111,"phoneExt":66,"email":112},"Dave Pickles","CONTACT","+441132433144","dave.pickles@nhs.net",{"name":114,"role":110,"phone":115,"phoneExt":66,"email":116},"Benaka Karanth","+44 1757 270044","bkaranth@namsa.com",[118,130,138,146,156,164,174,182,190,198,206,214,222,227,235,243,251,256,264,272,282,290,299,307,315,323,331,339,347,355,363,370,378,383,391,399,409,417,425,435,440,448,456,464,469,474,482,490,498,506,516,524,532,540,550,558,568,576,584,592,602,610,620,629,637,646,654,667,675,683,688,696,704,713,722],{"facility":119,"status":120,"city":121,"state":66,"zip":66,"country":122,"countryCode":123,"cosmosGeoPoint":124,"geoPoint":129,"contacts":66},"Aalborg Universitethospital","RECRUITING","Aalborg","Denmark","DK",{"type":125,"coordinates":126},"Point",[127,128],9.9187,57.048,{"lat":128,"lon":127},{"facility":131,"status":120,"city":132,"state":66,"zip":66,"country":122,"countryCode":123,"cosmosGeoPoint":133,"geoPoint":137,"contacts":66},"Århus Universitetshospital","Aarhus",{"type":125,"coordinates":134},[135,136],10.21076,56.15674,{"lat":136,"lon":135},{"facility":139,"status":120,"city":140,"state":66,"zip":66,"country":122,"countryCode":123,"cosmosGeoPoint":141,"geoPoint":145,"contacts":66},"Rigshospitalet","Copenhagen",{"type":125,"coordinates":142},[143,144],12.56553,55.67594,{"lat":144,"lon":143},{"facility":147,"status":120,"city":148,"state":66,"zip":66,"country":149,"countryCode":150,"cosmosGeoPoint":151,"geoPoint":155,"contacts":66},"HUS Helsinki University Hospital","Helsinki","Finland","FI",{"type":125,"coordinates":152},[153,154],24.93545,60.16952,{"lat":154,"lon":153},{"facility":157,"status":120,"city":158,"state":66,"zip":66,"country":149,"countryCode":150,"cosmosGeoPoint":159,"geoPoint":163,"contacts":66},"Turku University Hospital","Turku",{"type":125,"coordinates":160},[161,162],22.26869,60.45148,{"lat":162,"lon":161},{"facility":165,"status":120,"city":166,"state":66,"zip":66,"country":167,"countryCode":168,"cosmosGeoPoint":169,"geoPoint":173,"contacts":66},"Clinical Saint Augustin - Elsan","Bordeaux","France","FR",{"type":125,"coordinates":170},[171,172],-0.58046,44.84124,{"lat":172,"lon":171},{"facility":175,"status":120,"city":176,"state":66,"zip":66,"country":167,"countryCode":168,"cosmosGeoPoint":177,"geoPoint":181,"contacts":66},"Brest University Hospital Centre","Brest",{"type":125,"coordinates":178},[179,180],-4.48628,48.39029,{"lat":180,"lon":179},{"facility":183,"status":120,"city":184,"state":66,"zip":66,"country":167,"countryCode":168,"cosmosGeoPoint":185,"geoPoint":189,"contacts":66},"Henri Mondor University Hospital","Créteil",{"type":125,"coordinates":186},[187,188],2.46569,48.79266,{"lat":188,"lon":187},{"facility":191,"status":120,"city":192,"state":66,"zip":66,"country":167,"countryCode":168,"cosmosGeoPoint":193,"geoPoint":197,"contacts":66},"ICPS Hôpital privé Jacques-Cartier","Massy",{"type":125,"coordinates":194},[195,196],2.28301,48.72692,{"lat":196,"lon":195},{"facility":199,"status":120,"city":200,"state":66,"zip":66,"country":167,"countryCode":168,"cosmosGeoPoint":201,"geoPoint":205,"contacts":66},"Centre Hospitalier Universitaire de Montpellier","Montpellier",{"type":125,"coordinates":202},[203,204],3.87635,43.61093,{"lat":204,"lon":203},{"facility":207,"status":120,"city":208,"state":66,"zip":66,"country":167,"countryCode":168,"cosmosGeoPoint":209,"geoPoint":213,"contacts":66},"University Hospital of Nimes","Nîmes",{"type":125,"coordinates":210},[211,212],4.35788,43.83665,{"lat":212,"lon":211},{"facility":215,"status":120,"city":216,"state":66,"zip":66,"country":167,"countryCode":168,"cosmosGeoPoint":217,"geoPoint":221,"contacts":66},"Hospital Marie Lannelongue","Paris",{"type":125,"coordinates":218},[219,220],2.3488,48.85341,{"lat":220,"lon":219},{"facility":223,"status":120,"city":216,"state":66,"zip":66,"country":167,"countryCode":168,"cosmosGeoPoint":224,"geoPoint":226,"contacts":66},"Institute Mutualiste Montsouris",{"type":125,"coordinates":225},[219,220],{"lat":220,"lon":219},{"facility":228,"status":120,"city":229,"state":66,"zip":66,"country":167,"countryCode":168,"cosmosGeoPoint":230,"geoPoint":234,"contacts":66},"NCT - Saint-Gatien - Alliance","Saint-Cyr-sur-Loire",{"type":125,"coordinates":231},[232,233],0.66667,47.4,{"lat":233,"lon":232},{"facility":236,"status":120,"city":237,"state":66,"zip":66,"country":167,"countryCode":168,"cosmosGeoPoint":238,"geoPoint":242,"contacts":66},"Les Hospital Universitaires de Strasbourg","Strasbourg",{"type":125,"coordinates":239},[240,241],7.74553,48.58392,{"lat":241,"lon":240},{"facility":244,"status":120,"city":245,"state":66,"zip":66,"country":167,"countryCode":168,"cosmosGeoPoint":246,"geoPoint":250,"contacts":66},"Centre Hospitalier Universitaire de Toulouse, Hospital Rangueil","Toulouse",{"type":125,"coordinates":247},[248,249],1.44367,43.60426,{"lat":249,"lon":248},{"facility":252,"status":120,"city":245,"state":66,"zip":66,"country":167,"countryCode":168,"cosmosGeoPoint":253,"geoPoint":255,"contacts":66},"Clinique Pasteur Toulouse",{"type":125,"coordinates":254},[248,249],{"lat":249,"lon":248},{"facility":257,"status":120,"city":258,"state":66,"zip":66,"country":167,"countryCode":168,"cosmosGeoPoint":259,"geoPoint":263,"contacts":66},"CHRU Hospitals of Tours","Tours",{"type":125,"coordinates":260},[261,262],0.70398,47.39484,{"lat":262,"lon":261},{"facility":265,"status":120,"city":266,"state":66,"zip":66,"country":167,"countryCode":168,"cosmosGeoPoint":267,"geoPoint":271,"contacts":66},"Medipole Lyon-Villeurbanne","Villeurbanne",{"type":125,"coordinates":268},[269,270],4.8795,45.76601,{"lat":270,"lon":269},{"facility":273,"status":120,"city":274,"state":66,"zip":66,"country":275,"countryCode":276,"cosmosGeoPoint":277,"geoPoint":281,"contacts":66},"Kerckhoff Klinik","Bad Nauheim","Germany","DE",{"type":125,"coordinates":278},[279,280],8.73859,50.36463,{"lat":280,"lon":279},{"facility":283,"status":120,"city":284,"state":66,"zip":66,"country":275,"countryCode":276,"cosmosGeoPoint":285,"geoPoint":289,"contacts":66},"Herz- und Diabeteszentrum NRW","Bad Oeynhausen",{"type":125,"coordinates":286},[287,288],8.80365,52.20699,{"lat":288,"lon":287},{"facility":291,"status":292,"city":293,"state":66,"zip":66,"country":275,"countryCode":276,"cosmosGeoPoint":294,"geoPoint":298,"contacts":66},"Deutsches Herzzentrum Berlin","WITHDRAWN","Berlin",{"type":125,"coordinates":295},[296,297],13.41053,52.52437,{"lat":297,"lon":296},{"facility":300,"status":120,"city":301,"state":66,"zip":66,"country":275,"countryCode":276,"cosmosGeoPoint":302,"geoPoint":306,"contacts":66},"Universitatsklinikum Koln (AoR)","Cologne",{"type":125,"coordinates":303},[304,305],6.95,50.93333,{"lat":305,"lon":304},{"facility":308,"status":120,"city":309,"state":66,"zip":66,"country":275,"countryCode":276,"cosmosGeoPoint":310,"geoPoint":314,"contacts":66},"Klinikum Dortmund GmbH - St. Johannes Hospital","Dortmund",{"type":125,"coordinates":311},[312,313],7.466,51.51494,{"lat":313,"lon":312},{"facility":316,"status":120,"city":317,"state":66,"zip":66,"country":275,"countryCode":276,"cosmosGeoPoint":318,"geoPoint":322,"contacts":66},"Herzzentrum Dresden Universitätsklinik","Dresden",{"type":125,"coordinates":319},[320,321],13.73832,51.05089,{"lat":321,"lon":320},{"facility":324,"status":120,"city":325,"state":66,"zip":66,"country":275,"countryCode":276,"cosmosGeoPoint":326,"geoPoint":330,"contacts":66},"Universitatsklinikum Dusseldorf (University Hospital Dusseldorf)","Düsseldorf",{"type":125,"coordinates":327},[328,329],6.77927,51.22319,{"lat":329,"lon":328},{"facility":332,"status":120,"city":333,"state":66,"zip":66,"country":275,"countryCode":276,"cosmosGeoPoint":334,"geoPoint":338,"contacts":66},"Universitatsklinikum Frankfurt","Frankfurt",{"type":125,"coordinates":335},[336,337],10.53333,49.68333,{"lat":337,"lon":336},{"facility":340,"status":120,"city":341,"state":66,"zip":66,"country":275,"countryCode":276,"cosmosGeoPoint":342,"geoPoint":346,"contacts":66},"Asklepios Klinik St. Georg","Hamburg",{"type":125,"coordinates":343},[344,345],9.99302,53.55073,{"lat":345,"lon":344},{"facility":348,"status":120,"city":349,"state":66,"zip":66,"country":275,"countryCode":276,"cosmosGeoPoint":350,"geoPoint":354,"contacts":66},"Universitätsklinikum Schleswig-Holstein (UKSH)","Kiel",{"type":125,"coordinates":351},[352,353],10.13489,54.32133,{"lat":353,"lon":352},{"facility":356,"status":120,"city":357,"state":66,"zip":66,"country":275,"countryCode":276,"cosmosGeoPoint":358,"geoPoint":362,"contacts":66},"HELIOS Herzzentrum Leipzig GmbH","Leipzig",{"type":125,"coordinates":359},[360,361],12.37129,51.33962,{"lat":361,"lon":360},{"facility":348,"status":120,"city":364,"state":66,"zip":66,"country":275,"countryCode":276,"cosmosGeoPoint":365,"geoPoint":369,"contacts":66},"Lübeck",{"type":125,"coordinates":366},[367,368],10.68729,53.86893,{"lat":368,"lon":367},{"facility":371,"status":120,"city":372,"state":66,"zip":66,"country":275,"countryCode":276,"cosmosGeoPoint":373,"geoPoint":377,"contacts":66},"Deutsches Herzzentrum München (German Heartcentre Munich)","München",{"type":125,"coordinates":374},[375,376],13.31243,51.60698,{"lat":376,"lon":375},{"facility":379,"status":120,"city":372,"state":66,"zip":66,"country":275,"countryCode":276,"cosmosGeoPoint":380,"geoPoint":382,"contacts":66},"LMU Klinikum",{"type":125,"coordinates":381},[375,376],{"lat":376,"lon":375},{"facility":384,"status":120,"city":385,"state":66,"zip":66,"country":275,"countryCode":276,"cosmosGeoPoint":386,"geoPoint":390,"contacts":66},"Universitatsklinikum Tubingen","Tübingen",{"type":125,"coordinates":387},[388,389],9.05222,48.52266,{"lat":389,"lon":388},{"facility":392,"status":120,"city":393,"state":66,"zip":66,"country":275,"countryCode":276,"cosmosGeoPoint":394,"geoPoint":398,"contacts":66},"Universitatsklinikum Ulm (University Hospital Ulm)","Ulm",{"type":125,"coordinates":395},[396,397],9.99155,48.39841,{"lat":397,"lon":396},{"facility":400,"status":120,"city":401,"state":66,"zip":66,"country":402,"countryCode":403,"cosmosGeoPoint":404,"geoPoint":408,"contacts":66},"Edith Wolfson Medical Center","Holon","Israel","IL",{"type":125,"coordinates":405},[406,407],34.77918,32.01034,{"lat":407,"lon":406},{"facility":410,"status":120,"city":411,"state":66,"zip":66,"country":402,"countryCode":403,"cosmosGeoPoint":412,"geoPoint":416,"contacts":66},"Shaare Zedek Medical Center","Jerusalem",{"type":125,"coordinates":413},[414,415],35.21633,31.76904,{"lat":415,"lon":414},{"facility":418,"status":120,"city":419,"state":66,"zip":66,"country":402,"countryCode":403,"cosmosGeoPoint":420,"geoPoint":424,"contacts":66},"Rabin Medical Center - 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Bio-prosthetic Valve Failure (BVF) of a Transcatheter Aortic Valve requiring possible reintervention\n\nExclusion Criteria:\n\n1. Bio-prosthetic Valve Failure due solely to paravalvular aortic regurgitation\n2. Active endocarditis\n3. Untreated acute valve thrombosis\n4. Life-expectancy less than 1 year\n5. Subject is less than legal age of consent, legally incompetent, or otherwise vulnerable\n6. Pregnant or nursing","ALL","18 Years",{"count":749,"type":750},550,"ESTIMATED","OBSERVATIONAL","Transcatheter aortic valve implantation (TAVI) is a key-hole technique to replace an aortic heart valve that is narrowed and\u002For leaking. Although TAVI is a safe and effective treatment for a faulty aortic heart valve, the new TAVI valve will not last forever. Because it is a 'tissue' valve (made from the lining of a cow or pig heart), the valve will fail after a period of time as the tissue degenerates.\n\nWhen the TAVI valve fails, a viable treatment option is to perform a 'Redo TAVI' procedure, implanting a second TAVI valve inside the first failing valve.\n\nThe main purpose of this study is to carefully evaluate patients being treated by Redo TAVI in order to document the short-term and long-term outcomes of the procedure. 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