[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100561461":3},{"organization":4,"outcomesModule":7,"designInfo":18,"detailedDescription":21,"studyPopulation":22,"armGroups":23,"interventions":34,"overallOfficials":70,"centralContacts":75,"locations":85,"responsibleParty":591,"collaborators":17,"id":593,"slug":594,"hasResults":595,"nctId":596,"briefTitle":597,"officialTitle":597,"acronym":598,"eligibilityCriteria":599,"healthyVolunteers":595,"sex":600,"minAge":17,"maxAge":17,"enrollmentInfo":601,"targetDuration":17,"studyType":604,"phases":17,"briefSummary":605,"conditions":606,"keywords":613,"overallStatus":149,"whyStopped":17,"lastUpdateSubmitDate":627,"lastUpdatePostDateStruct":628,"startDateStruct":631,"completionDateStruct":633,"leadSponsor":635,"locationsCount":636},{"fullName":5,"class":6},"Abbott Medical Devices","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":17,"otherOutcomes":17},[9,13],{"measure":10,"description":11,"timeFrame":12},"Primary Safety Endpoint","The primary safety endpoint will be the proportion of subjects with device- and\u002For procedure-related serious adverse events (SAEs) occurring within 7 days of the procedure.","7 days",{"measure":14,"description":15,"timeFrame":16},"Primary Effectiveness Endpoint","The primary effectiveness endpoint will be the proportion of procedures that achieved technical success, defined as completion of the procedure with an applicable Abbott SH device implanted","Baseline",null,{"allocation":17,"interventionModel":17,"interventionModelDescription":17,"primaryPurpose":17,"observationalModel":19,"timePerspective":20,"maskingInfo":17},"COHORT","OTHER","The Abbott SH Device Registry is designed to confirm the safety and performance of commercially available Abbott SH devices as they are used in routine hospital practice or SOC procedures. Patients will be screened for eligibility and willingness to participate prior to the procedure or, if enrolled retrospectively, within the following timeframes:\n\n* Amplatzer portion: within 7 days post-procedure\n* Cardiac Surgery portion (The ENDURE Study): within 6 months post-procedure.\n\nAll patients who provide informed consent and undergo an implant attempt with an applicable Abbott SH device are eligible to participate in the Registry. The Registry anticipates that approximately 500 subjects per year will be enrolled. The projected enrollment period is at least 5 years.\n\nThe Registry will be conducted at approximately 25 sites worldwide. Additional sites may be approached for participation in the Registry as needed.\n\nFollow-up visits should align with the site's routine SOC visits for the associated procedure. Data collection will occur post-screening and consent and at post-procedure SOC follow-up visit(s). Where applicable, follow-up visits may occur over the telephone, virtually, or in-office, following SOC practice.\n\nThe follow-up duration will depend on the Abbott device(s) used during the procedure. Certain devices will utilize data collection at discharge (or 7 days post procedure, whichever comes first), short-term (1 - 3 months as applicable), a mid-term (6 months), and long-term follow-up (12 months) visits to support clinical safety and performance data requirements. Alternatively, some devices will have follow-up visits extending up to 10 years to monitor subjects throughout the devices' lifetime.\n\nA surgical valve-specific \"Line Extension Sub-Study\" is included in the protocol to collect data at European sites with the intention of applying for approval in the US for 2 specific surgical aortic valve sizes (Epic Max 27mm, and the Epic Plus Supra 29mm).","This Registry is open to enroll subjects of all genders and ages from the general population who undergo a procedure that use at least one Abbott SH device included in this Registry (including unsuccessful implants). Subjects must meet all eligibility criteria and provide written informed consent prior to sites conducting any investigation-specific procedures not considered standard of care.\n\nPatients will be screened for eligibility and willingness to participate prior to the procedure or, if enrolled retrospectively, within the timeframe specified in the device-specific appendices of the protocol (Amplatzer cohort: consent within 7days of procedure \u002F\u002F Cardiac Surgery (The ENDURE Study) cohort: consent within 6 months (183 days) of the implant procedure)",[24,29],{"label":25,"type":17,"description":26,"interventionNames":27},"Amplatzer","* ASO: ≥50 cases\u002Fyear\n* ASD-MF: ≥50 cases\u002Fyear\n* ADO: ≥50 cases\u002Fyear\n* ADO II: ≥50 cases\u002Fyear\n* Piccolo: ≥50 cases\u002Fyear\n* MuVSD: Up to 50 cases\u002Fyear\n* PI-VSD: Up to 50 cases\u002Fyear\n* Talisman\u002FTDS: ≥100 cases\u002Fyear\n* TorqVue Delivery Systems Group 1 (ATV\u002FITV\u002FEITV\u002FTV2): 250 cases\u002Fyear across different occluders\n* TorqVue Delivery Systems Group 2 (TVLP\u002FTVLPC): 100 cases\u002Fyear across different occluders\n* Piccolo Delivery System (PDS): 50 cases total\n* SB II:100 PFO cases\u002Fyear \\& 100 ASD cases\u002Fyear\n* GW: 200 cases\u002Fyear",[28],"Device: Amplatzer™ Occlusion Devices",{"label":30,"type":17,"description":31,"interventionNames":32},"Cardiac Surgery (The ENDURE Study)","Approximately 1,800 subjects implanted with at least one applicable Abbott surgical tissue heart valve (THV) will be enrolled and followed for 10 years. The minimum required sample sizes for each THV model are listed below. Approximately N=100 Epic Max enrollments will occur in the United States. A combined total of approximately N=1000 subjects will be enrolled globally across the Epic Elite (aortic and mitral) and Epic Supra G3 models.\n\n* Approximately 225 subjects receiving Epic Plus mitral valves\n* Approximately 225 subjects receiving Epic Elite mitral valves\n* Approximately 150 subjects receiving Epic Plus aortic valves\n* Approximately 170 subjects receiving Epic Plus Supra aortic valves\n* Approximately 170 subjects receiving Epic Supra G3 aortic valves\n* Approximately 285 subjects receiving Epic Max aortic valves\n* Approximately 285 subjects receiving Epic Elite aortic valves",[33],"Device: Epic™ Surgical Tissue Heart Valve devices",[35,50],{"type":36,"name":37,"description":38,"armGroupLabels":39,"otherNames":40},"DEVICE","Amplatzer™ Occlusion Devices","The Amplatzer™ Occluders are devices intended for the occlusion of multiple septal heart defects.",[25],[41,42,43,44,45,46,47,48,49],"Amplatzer Septal Occluder","Amplatzer Multi-fenestrated (Cribriform) Occluder","Amplatzer Duct Occluder","Amplatzer Piccolo Occluder","Amplatzer Muscular VSD Occluder","Amplatzer Post-Infarct VSD Occluder","Amplatzer Talisman","Amplatzer TorqVue Delivery System","Amplatzer Piccolo Delivery System",{"type":36,"name":51,"description":52,"armGroupLabels":53,"otherNames":54},"Epic™ Surgical Tissue Heart Valve devices","The Epic™ valves are indicated for patients requiring replacement of a diseased, damaged, or malfunctioning native aortic\u002Fmitral heart valve. It may also be used as a replacement for a previously implanted aortic\u002Fmitral prosthetic heart valve.",[30],[55,56,57,58,59,60,61,62,63,64,65,66,67,68,69],"EMAX","E200","ESP200","Sizer Set Model E2000","Sizer Set Model EMAX-1000","Replacement Holder Handles E2000-HA and E2000-HM","Sizer Set Model ESP-1000A","Sizer Set Model EELT-1000A","Sizer Set Model EELT-1000M","Epic Plus Single Sizers Models (Aortic): E2000-19A-S, E2000-21A-S, E2000-23A-S, E2000-25A-S, E2000-27A-S, E2000-29A-S","Epic Plus Single Sizers Models (Mitral): E2000-25M-S, E2000-27M-S, E2000-29M-S, E2000-31M-S, E2000-33M-S","Epic Elite Single Sizers Models (Aortic): EELT-19A-S, EELT-21A-S, EELT-23A-S, EELT-25A-S, EELT-27A-S, EELT-29A-S","EELT","ESP300","Sizer Set Model EF-3000",[71],{"name":72,"affiliation":73,"role":74},"Mary Seale","Abbott","STUDY_DIRECTOR",[76,81],{"name":77,"role":78,"phone":79,"phoneExt":17,"email":80},"Laetitia Beullens","CONTACT","+32 277 46 937","laetitia.beullens@abbott.com",{"name":82,"role":78,"phone":83,"phoneExt":17,"email":84},"Kayla Dellefratte","+16692149748","kayla.dellefratte@abbott.com",[86,105,119,133,147,162,175,185,199,213,226,240,254,268,284,299,315,328,341,357,371,384,398,412,425,441,457,466,480,494,510,526,540,553,566,581],{"facility":87,"status":88,"city":89,"state":90,"zip":91,"country":92,"countryCode":93,"cosmosGeoPoint":94,"geoPoint":99,"contacts":100},"USC University Hospital","NOT_YET_RECRUITING","Los Angeles","California","90033","United States","US",{"type":95,"coordinates":96},"Point",[97,98],-118.24368,34.05223,{"lat":98,"lon":97},[101,103],{"name":102,"role":78,"phone":17,"phoneExt":17,"email":17},"Craig Baker, MD",{"name":102,"role":104,"phone":17,"phoneExt":17,"email":17},"PRINCIPAL_INVESTIGATOR",{"facility":106,"status":88,"city":107,"state":108,"zip":109,"country":92,"countryCode":93,"cosmosGeoPoint":110,"geoPoint":114,"contacts":115},"MedStar Washington Hospital Center","Washington D.C.","District of Columbia","20010",{"type":95,"coordinates":111},[112,113],-77.03637,38.89511,{"lat":113,"lon":112},[116,118],{"name":117,"role":78,"phone":17,"phoneExt":17,"email":17},"Thomas MacGillivray, MD",{"name":117,"role":104,"phone":17,"phoneExt":17,"email":17},{"facility":120,"status":88,"city":121,"state":122,"zip":123,"country":92,"countryCode":93,"cosmosGeoPoint":124,"geoPoint":128,"contacts":129},"Baptist Hospital of Miami","Miami","Florida","33176",{"type":95,"coordinates":125},[126,127],-80.19366,25.77427,{"lat":127,"lon":126},[130,132],{"name":131,"role":78,"phone":17,"phoneExt":17,"email":17},"Tom Nguyen, MD",{"name":131,"role":104,"phone":17,"phoneExt":17,"email":17},{"facility":134,"status":88,"city":135,"state":136,"zip":137,"country":92,"countryCode":93,"cosmosGeoPoint":138,"geoPoint":142,"contacts":143},"Washington University School of Medicine","St Louis","Missouri","63110",{"type":95,"coordinates":139},[140,141],-90.19789,38.62727,{"lat":141,"lon":140},[144,146],{"name":145,"role":78,"phone":17,"phoneExt":17,"email":17},"Tsuyoshi Kaneko, MD",{"name":145,"role":104,"phone":17,"phoneExt":17,"email":17},{"facility":148,"status":149,"city":150,"state":151,"zip":152,"country":92,"countryCode":93,"cosmosGeoPoint":153,"geoPoint":157,"contacts":158},"Robert Wood Johnson University Hospital","RECRUITING","New Brunswick","New Jersey","08901",{"type":95,"coordinates":154},[155,156],-74.45182,40.48622,{"lat":156,"lon":155},[159,161],{"name":160,"role":78,"phone":17,"phoneExt":17,"email":17},"Leonard Lee, MD",{"name":160,"role":104,"phone":17,"phoneExt":17,"email":17},{"facility":163,"status":149,"city":164,"state":164,"zip":165,"country":92,"countryCode":93,"cosmosGeoPoint":166,"geoPoint":170,"contacts":171},"Mount Sinai Hospital","New York","10029",{"type":95,"coordinates":167},[168,169],-74.00597,40.71427,{"lat":169,"lon":168},[172,174],{"name":173,"role":78,"phone":17,"phoneExt":17,"email":17},"Ismail El-Hamamsy, MD",{"name":173,"role":104,"phone":17,"phoneExt":17,"email":17},{"facility":176,"status":88,"city":164,"state":164,"zip":177,"country":92,"countryCode":93,"cosmosGeoPoint":178,"geoPoint":180,"contacts":181},"New York Presbyterian Hospital\u002FCornell University","10065",{"type":95,"coordinates":179},[168,169],{"lat":169,"lon":168},[182,184],{"name":183,"role":78,"phone":17,"phoneExt":17,"email":17},"Joshua Goldberg, MD",{"name":183,"role":104,"phone":17,"phoneExt":17,"email":17},{"facility":186,"status":88,"city":187,"state":188,"zip":189,"country":92,"countryCode":93,"cosmosGeoPoint":190,"geoPoint":194,"contacts":195},"The Cleveland Clinic Foundation","Cleveland","Ohio","44195",{"type":95,"coordinates":191},[192,193],-81.69541,41.4995,{"lat":193,"lon":192},[196,198],{"name":197,"role":78,"phone":17,"phoneExt":17,"email":17},"Edward Soltesz, MD",{"name":197,"role":104,"phone":17,"phoneExt":17,"email":17},{"facility":200,"status":88,"city":201,"state":202,"zip":203,"country":92,"countryCode":93,"cosmosGeoPoint":204,"geoPoint":208,"contacts":209},"University of Pennsylvania","Philadelphia","Pennsylvania","19104",{"type":95,"coordinates":205},[206,207],-75.16362,39.95238,{"lat":207,"lon":206},[210,212],{"name":211,"role":78,"phone":17,"phoneExt":17,"email":17},"Chase Brown, 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MD",{"name":238,"role":104,"phone":17,"phoneExt":17,"email":17},{"facility":241,"status":88,"city":242,"state":243,"zip":244,"country":92,"countryCode":93,"cosmosGeoPoint":245,"geoPoint":249,"contacts":250},"University of Washington Medical Center","Seattle","Washington","98195",{"type":95,"coordinates":246},[247,248],-122.33207,47.60621,{"lat":248,"lon":247},[251,253],{"name":252,"role":78,"phone":17,"phoneExt":17,"email":17},"Scott DeRoo, MD",{"name":252,"role":104,"phone":17,"phoneExt":17,"email":17},{"facility":255,"status":88,"city":256,"state":257,"zip":258,"country":92,"countryCode":93,"cosmosGeoPoint":259,"geoPoint":263,"contacts":264},"Mayo Clinic Health System - Eau Claire Hospital, Inc.","Eau Claire","Wisconsin","54702",{"type":95,"coordinates":260},[261,262],-91.49849,44.81135,{"lat":262,"lon":261},[265,267],{"name":266,"role":78,"phone":17,"phoneExt":17,"email":17},"Robert Wiechmann, 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Prof.",{"name":297,"role":104,"phone":17,"phoneExt":17,"email":17},{"facility":300,"status":149,"city":301,"state":302,"zip":303,"country":304,"countryCode":305,"cosmosGeoPoint":306,"geoPoint":310,"contacts":311},"CHU Rennes, Pontchaillou","Rennes","Brittan","35033","France","FR",{"type":95,"coordinates":307},[308,309],-1.67431,48.11109,{"lat":309,"lon":308},[312,314],{"name":313,"role":78,"phone":17,"phoneExt":17,"email":17},"Amedeo Anselmi",{"name":313,"role":104,"phone":17,"phoneExt":17,"email":17},{"facility":316,"status":149,"city":317,"state":17,"zip":318,"country":304,"countryCode":305,"cosmosGeoPoint":319,"geoPoint":323,"contacts":324},"Hôpital Marie-Lannelongue","Le Plessis-Robinson","92350",{"type":95,"coordinates":320},[321,322],2.27078,48.78889,{"lat":322,"lon":321},[325,327],{"name":326,"role":78,"phone":17,"phoneExt":17,"email":17},"Sebastien Hascoet, 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med.",{"name":355,"role":104,"phone":17,"phoneExt":17,"email":17},{"facility":358,"status":149,"city":359,"state":360,"zip":361,"country":346,"countryCode":347,"cosmosGeoPoint":362,"geoPoint":366,"contacts":367},"Klinikum Links der Weser","Bremen","Free Hanseatic City of Bremen","28277",{"type":95,"coordinates":363},[364,365],8.80717,53.07582,{"lat":365,"lon":364},[368,370],{"name":369,"role":78,"phone":17,"phoneExt":17,"email":17},"Jens Garbade, Prof. Dr. med.",{"name":369,"role":104,"phone":17,"phoneExt":17,"email":17},{"facility":372,"status":149,"city":373,"state":346,"zip":374,"country":346,"countryCode":347,"cosmosGeoPoint":375,"geoPoint":379,"contacts":380},"Universitatsklinikum Jena","Jena","07747",{"type":95,"coordinates":376},[377,378],11.5899,50.92878,{"lat":378,"lon":377},[381,383],{"name":382,"role":78,"phone":17,"phoneExt":17,"email":17},"Torsten Doenst, Prof. Dr.",{"name":382,"role":104,"phone":17,"phoneExt":17,"email":17},{"facility":385,"status":149,"city":386,"state":387,"zip":388,"country":346,"countryCode":347,"cosmosGeoPoint":389,"geoPoint":393,"contacts":394},"Städt. 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Subject is expected to undergo an implant attempt using one or more Abbott Structural Heart devices covered in this Registry or has previously undergone an implant attempt within the timeframes specified in the device-specific appendices.\n2. Subject is willing and able to comply with the site's standard of care follow-up schedule.\n3. Subject is willing to provide appropriate informed consent for Registry participation. For deceased subjects enrolled retrospectively, local regulations and EC\u002FIRB recommendations regarding consent and the protection of personal data must be followed.\n\nExclusion Criteria:\n\n1\\. Subject is participating in another clinical study that would affect the results of this Registry.","ALL",{"count":602,"type":603},2500,"ESTIMATED","OBSERVATIONAL","The Abbott Structural Heart (SH) Registry is being conducted to confirm the safety and performance of Abbott's SH devices in a post-market, real-world setting. The Registry primarily involves gathering data from routine hospital practices and standard-of-care (SOC) procedures administered to patients. All devices used in these procedures must be commercially available to the participating site. A list of specific devices covered by the Registry are available upon request from the Sponsor. 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