[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05932615":3,"trial-entities:NCT05932615":701,"trial-summary:NCT05932615":706},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":23,"study_type":29,"primary_purpose":30,"phases":31,"enrollment_info":33,"interventions":36,"primary_outcomes":46,"secondary_outcomes":51,"sex":52,"minimum_age":53,"maximum_age":54,"healthy_volunteers":55,"eligibility_criteria":56,"std_ages":60,"locations":63,"central_contacts":680,"overall_officials":681,"references":699,"see_also_links":700},"NCT05932615","ABT-CIP-10487","ENVISION IDE Trial: Safety and Effectiveness of NAVITOR in Transcatheter Aortic Valve Implantation","Evaluation of the Navitor Transcatheter Heart Valve in Low and Intermediate Risk Patients Who Have Severe, Symptomatic, Aortic Stenosis Requiring Aortic Valve Replacement","ENROLLING_BY_INVITATION","2036-04","2026-05","2026-05-08","2024-03-15","Abbott Medical Devices","INDUSTRY",true,"The objective of ENVISION is to evaluate the safety and effectiveness of the Navitor Transcatheter Aortic Valve Implantation (TAVI) System for treating patients with symptomatic, severe native aortic stenosis who are considered intermediate or low risk for surgical mortality.\n\nThe trial will also evaluate the safety and effectiveness of the Navitor TAVI System in a valve-in-valve (ViV) application in patients with symptomatic heart disease due to failure of a surgical or transcatheter bioprosthetic aortic valve who are at high or greater surgical risk.\n\nIn addition, the trial will assess the safety of the Navitor TAVI System for the treatment of symptomatic, severe native aortic stenosis in patients with bicuspid aortic valve anatomy, irrespective of surgical risk classification.","ENVISION is a prospective, multi-center clinical investigation at up to 135 sites globally. The objective of this clinical investigation is to evaluate the safety and effectiveness of the Navitor TAVI System for treating patients with symptomatic, severe native aortic stenosis who are considered intermediate or low risk for surgical mortality. The trial will register subjects in three separate cohorts: (1) a pivotal randomized cohort, (2) a valve-in-valve (ViV) cohort and (3) a bicuspid cohort.\n\nThe objective of the pivotal randomized cohort is to evaluate the safety and effectiveness of the Navitor TAVI System for treating patients with symptomatic, severe native aortic stenosis who are considered intermediate or low risk for surgical mortality.\n\nThe Randomization Cohort will enroll approximately 1500 subjects and will be randomized between the Navitor TAVI Implantation System (test arm) and any commercially available transcatheter aortic valve system (CAV) (control arm) in a 1:1 ratio.\n\nThe ViV cohort will be conducted as a separate prospective, multicenter, open label, two-group registry within the ENVISION IDE trial. A total of 250 subjects deemed to be at high or greater risk for open surgical therapy will be enrolled concurrently across two separate groups: 125 subjects undergoing transcatheter Aortic Valve-in-Surgical Aortic Valve replacement (TAV-in-SAV) and 125 subjects undergoing Transcatheter Aortic Valve-in-Transcatheter Aortic Valve replacement (TAV-in-TAV).\n\nThe bicuspid cohort will be conducted as a separate, prospective multicenter, open label study within the ENVISION IDE trial. A total of 250 symptomatic, severe aortic stenosis subjects with bicuspid aortic valve anatomy who are deemed suitable for transcatheter aortic valve implantation with a Navitor valve will be enrolled.",[19,20,21,22],"Aortic Valve Stenosis","Heart Valve Diseases","Aortic Valve Disease","Heart Disease Structural Disorder",[24,25,26,27,28],"NAVITOR","Heart disease","Transcatheter aortic valve implantation (TAVI)","Aortic stenosis","Cardiovascular diseases","INTERVENTIONAL","TREATMENT",[32],"NA",{"count":34,"type":35},1500,"ESTIMATED",[37,42],{"type":38,"name":39,"description":40,"armGroupLabels":41},"DEVICE","Navitor Transcatheter Aortic Valve Implantation (TAVI) System","TAVI for relief of calcific aortic stenosis in patients with symptomatic heart disease who are at intermediate or low risk for open surgical therapy.",[39],{"type":38,"name":43,"description":40,"armGroupLabels":44},"Any Commercially Available Transcatheter Aortic Valve (CAV) System",[45],"Any Commercially Available Transcatheter Aortic Valve System (CAV)",[47],{"measure":48,"description":49,"timeFrame":50},"Composite of all-cause mortality or all stroke","Number of patients that had any of the outcome events.","At 12 months post-procedure",[],"ALL","18 Years",null,false,{"inclusion":57,"exclusion":58,"raw_text":59},[],[],"Key Inclusion Criteria:\n\n1. Subject who is deemed to be at intermediate or low risk for open surgical aortic valve replacement:\n\n   1. Intermediate risk: estimated risk of overall surgical mortality ≥ 3% and \\\u003C 8% at 30 days\n   2. Low risk: estimated risk of overall surgical mortality \\\u003C 3% at 30 days Estimated risk of overall surgical mortality includes consideration of the Society of Thoracic Surgeons (STS) risk score, overall clinical status, and other clinical co-morbidities unmeasured by the risk calculator\n2. New York Heart Association (NYHA) Functional Classification of II, III, or IV\n3. Degenerative aortic valve stenosis\n\nKey Exclusion Criteria:\n\n1. In the opinion of the Investigator, life expectancy is less than 2 years\n2. Evidence of an acute myocardial infarction \\[defined as ST-segment elevation myocardial infarction (STEMI) or non-ST-segment elevation myocardial infarction (NSTEMI) with acute ischemia symptoms and troponin elevation\\] within 30 days prior to index procedure\n3. Untreated clinically significant coronary artery disease requiring revascularization\n4. Any percutaneous coronary or peripheral interventional procedure performed within 30 days prior (except pacemaker or implantable cardioverter defibrillator (ICD) implant) to index procedure or planned within 30 days following the index procedure\n5. Blood dyscrasias as defined: leukopenia (WBC \\\u003C 3000 mm3), acute anemia (Hb \\\u003C 9 g\u002FdL), thrombocytopenia (platelet count \\\u003C 50,000 cells\u002Fmm³); history of bleeding diathesis or coagulopathy\n6. Active peptic ulcer or upper GI bleeding within 3 months prior to index procedure that would preclude anticoagulation\n7. Recent (within 6 months prior to index procedure date) cerebrovascular accident (CVA) or a transient ischemic attack (TIA)\n8. Renal insufficiency (creatinine \\> 3.0 mg\u002FdL or eGFR \\\u003C 30 ml\u002Fmin\u002F1.73m2) and\u002For end stage renal disease requiring chronic dialysis\n9. Hostile chest or conditions or complications from prior surgery that would make the subject be considered high surgical risk (i.e., mediastinitis, radiation damage, abnormal chest wall, porcelain aorta, adhesion of aorta or internal mammary artery to sternum, etc.)\n10. Significant frailty as determined by the heart team (after objective assessment of frailty parameters) that would indicate high or extreme surgical risk\n11. Mixed aortic valve disease (aortic stenosis and aortic regurgitation with predominant aortic regurgitation 3-4+)\n12. Aortic valve is a unicuspid or bicuspid valve as verified by echocardiography or CT.\n13. Severe ventricular dysfunction with LVEF \\\u003C 30% as measured by resting echocardiogram\n14. Pre-existing prosthetic heart valve or other implant (such as prosthetic ring or transcatheter edge-to-edge repair (TEER) clip) in any valve position\n15. Severe circumferential mitral annular calcification (MAC) which is continuous with calcium in the left ventricular outflow tract (LVOT)\n16. Severe (greater than or equal to 3+) mitral regurgitation or severe mitral stenosis\n17. Minimum access vessel diameter of \\\u003C 5.0 mm for small FlexNav Delivery System and \\\u003C 5.5 mm for large FlexNav Delivery System\n18. Eccentricity ratio of the annulus \\\u003C 0.73\n\nAdditional Exclusion Criteria for Pivotal Randomized Cohort\n\n1. Hostile Chest or conditions or complications from prior surgery that would make the subject be considered high surgical risk\n2. Significant frailty as determined by the heart team (after objective assessment of frailty parameters) that would indicate high or extreme surgical risk\n3. Mixed aortic valve disease\n4. Aortic valve is a unicuspid or bicuspid valve as verified by echocardiography or CT\n5. Inadequate aortic valve calcification\n6. Pre-existing prosthetic heart valve or other implant (such as prosthetic ring or transcatheter edge-to-edge repair (TEER) clip) in any valve position\n\nAdditional Exclusion Criteria for ViV Cohort\n\n1. Failing valve has moderate or greater paravalvular regurgitation.\n2. Known severe prosthesis-patient mismatch\n3. Failing valve is unstable, rocking, or not structurally intact.\n4. Patient has a pre-existing prosthetic heart valve or other implant (such a prosthetic ring with a rigid support structure or transcatheter edge-to-edge repair clip) in any valve position other than aortic.\n5. Bioprosthetic valve diameter that would not accommodate implantation of the Navitor Valve.\n6. Increased risk of coronary obstruction by prosthetic leaflets of the index valve\n\nAdditional Exclusion Criteria for bicuspid cohort\n\n1. In the opinion of the Investigator life expectancy is less than 1 year\n2. Inadequate or severe aortic valve calcification and\u002For anatomical features that would preclude safe delivery of the valve",[61,62],"ADULT","OLDER_ADULT",[64,73,81,88,96,104,111,118,125,132,139,147,155,162,169,176,183,190,198,205,213,221,228,231,239,247,255,263,271,278,286,293,300,307,315,323,331,338,346,353,357,361,368,376,383,391,398,405,413,421,428,432,439,447,455,462,470,474,481,488,491,498,506,514,521,529,537,545,554,562,570,577,586,594,601,609,613,620,629,637,645,654,663,672],{"facility":65,"city":66,"state":67,"zip":68,"country":69,"geoPoint":70},"University Hospital - Univ. of Alabama at Birmingham (UAB)","Birmingham","Alabama","35233","United States",{"lat":71,"lon":72},33.52066,-86.80249,{"facility":74,"city":75,"state":76,"zip":77,"country":69,"geoPoint":78},"St. Joseph's Hospital & Medical Center","Phoenix","Arizona","85013",{"lat":79,"lon":80},33.44838,-112.07404,{"facility":82,"city":83,"state":76,"zip":84,"country":69,"geoPoint":85},"Tucson Medical Center","Tucson","85712",{"lat":86,"lon":87},32.22174,-110.92648,{"facility":89,"city":90,"state":91,"zip":92,"country":69,"geoPoint":93},"Arkansas Heart Hospital","Little Rock","Arkansas","72211",{"lat":94,"lon":95},34.74648,-92.28959,{"facility":97,"city":98,"state":99,"zip":100,"country":69,"geoPoint":101},"Kaiser Permanente Fontana Medical Center","Fontana","California","92335",{"lat":102,"lon":103},34.09223,-117.43505,{"facility":105,"city":106,"state":99,"zip":107,"country":69,"geoPoint":108},"Southern California Permanente Medical Group - La Jolla","La Jolla","92037",{"lat":109,"lon":110},32.84727,-117.2742,{"facility":112,"city":113,"state":99,"zip":114,"country":69,"geoPoint":115},"University of California at San Francisco","San Francisco","94143",{"lat":116,"lon":117},37.77493,-122.41942,{"facility":119,"city":120,"state":99,"zip":121,"country":69,"geoPoint":122},"Stanford University Medical Center","Stanford","94305",{"lat":123,"lon":124},37.42411,-122.16608,{"facility":126,"city":127,"state":99,"zip":128,"country":69,"geoPoint":129},"Los Robles Regional Medical Center","Thousand Oaks","91360",{"lat":130,"lon":131},34.17056,-118.83759,{"facility":74,"city":133,"state":134,"zip":135,"country":69,"geoPoint":136},"Denver","Colorado","80218",{"lat":137,"lon":138},39.73915,-104.9847,{"facility":140,"city":141,"state":142,"zip":143,"country":69,"geoPoint":144},"Washington Hospital Center","Washington D.C.","District of Columbia","20010",{"lat":145,"lon":146},38.89511,-77.03637,{"facility":148,"city":149,"state":150,"zip":151,"country":69,"geoPoint":152},"HCA Florida - JFK Hospital","Atlantis","Florida","33462",{"lat":153,"lon":154},26.5909,-80.10088,{"facility":156,"city":157,"state":150,"zip":158,"country":69,"geoPoint":159},"HCA Florida Largo Hospital","Largo","33770",{"lat":160,"lon":161},27.90979,-82.78842,{"facility":163,"city":164,"state":150,"zip":165,"country":69,"geoPoint":166},"Baptist Hospital of Miami","Miami","33176",{"lat":167,"lon":168},25.77427,-80.19366,{"facility":170,"city":171,"state":150,"zip":172,"country":69,"geoPoint":173},"HCA Florida Ocala Hospital","Ocala","34471",{"lat":174,"lon":175},29.1872,-82.14009,{"facility":177,"city":178,"state":150,"zip":179,"country":69,"geoPoint":180},"AdventHealth Orlando","Orlando","32825",{"lat":181,"lon":182},28.53834,-81.37924,{"facility":184,"city":185,"state":150,"zip":186,"country":69,"geoPoint":187},"Tallahassee Research Institute","Tallahassee","32308",{"lat":188,"lon":189},30.43826,-84.28073,{"facility":191,"city":192,"state":193,"zip":194,"country":69,"geoPoint":195},"Piedmont Heart Institute","Atlanta","Georgia","30309",{"lat":196,"lon":197},33.749,-84.38798,{"facility":199,"city":200,"state":193,"zip":201,"country":69,"geoPoint":202},"Northeast Georgia Medical Center","Gainesville","30501",{"lat":203,"lon":204},34.29788,-83.82407,{"facility":206,"city":207,"state":208,"zip":209,"country":69,"geoPoint":210},"The Queen's Medical Center","Honolulu","Hawaii","96814",{"lat":211,"lon":212},21.30694,-157.85833,{"facility":214,"city":215,"state":216,"zip":217,"country":69,"geoPoint":218},"University of Chicago Medical Center","Chicago","Illinois","60637",{"lat":219,"lon":220},41.85003,-87.65005,{"facility":222,"city":223,"state":216,"zip":224,"country":69,"geoPoint":225},"Endeavor Health","Evanston","60201",{"lat":226,"lon":227},42.04114,-87.69006,{"facility":229,"city":223,"state":216,"zip":224,"country":69,"geoPoint":230},"Northwestern Memorial Hospital",{"lat":226,"lon":227},{"facility":232,"city":233,"state":234,"zip":235,"country":69,"geoPoint":236},"Ascension St. Vincent","Indianapolis","Indiana","46290",{"lat":237,"lon":238},39.76838,-86.15804,{"facility":240,"city":241,"state":242,"zip":243,"country":69,"geoPoint":244},"Via Christi Regional Medical Center - St. Francis Campus","Wichita","Kansas","67226",{"lat":245,"lon":246},37.69224,-97.33754,{"facility":248,"city":249,"state":250,"zip":251,"country":69,"geoPoint":252},"Ochsner Medical Center","New Orleans","Louisiana","70121",{"lat":253,"lon":254},29.95465,-90.07507,{"facility":256,"city":257,"state":258,"zip":259,"country":69,"geoPoint":260},"MedStar Union Memorial Hospital","Baltimore","Maryland","21218",{"lat":261,"lon":262},39.29038,-76.61219,{"facility":264,"city":265,"state":266,"zip":267,"country":69,"geoPoint":268},"Massachusetts General Hospital","Boston","Massachusetts","02114",{"lat":269,"lon":270},42.35843,-71.05977,{"facility":272,"city":273,"state":266,"zip":274,"country":69,"geoPoint":275},"University of Massachusetts Medical Center","Worcester","01655",{"lat":276,"lon":277},42.26259,-71.80229,{"facility":279,"city":280,"state":281,"zip":282,"country":69,"geoPoint":283},"University of Michigan","Ann Arbor","Michigan","48109",{"lat":284,"lon":285},42.27756,-83.74088,{"facility":287,"city":288,"state":281,"zip":289,"country":69,"geoPoint":290},"Henry Ford Hospital","Detroit","48202",{"lat":291,"lon":292},42.33143,-83.04575,{"facility":294,"city":295,"state":281,"zip":296,"country":69,"geoPoint":297},"Western Michigan Univ. Homer Stryker M.D. School of Medicine","Kalamazoo","49048",{"lat":298,"lon":299},42.29171,-85.58723,{"facility":301,"city":302,"state":281,"zip":303,"country":69,"geoPoint":304},"MyMichigan Medical Center Midland","Midland","48670",{"lat":305,"lon":306},43.61558,-84.24721,{"facility":308,"city":309,"state":310,"zip":311,"country":69,"geoPoint":312},"Mayo Clinic","Rochester","Minnesota","55905",{"lat":313,"lon":314},44.02163,-92.4699,{"facility":316,"city":317,"state":318,"zip":319,"country":69,"geoPoint":320},"Saint Luke's Hospital of Kansas City","Kansas City","Missouri","64111",{"lat":321,"lon":322},39.09973,-94.57857,{"facility":324,"city":325,"state":326,"zip":327,"country":69,"geoPoint":328},"Morristown Medical Center","Morristown","New Jersey","07962",{"lat":329,"lon":330},40.79677,-74.48154,{"facility":332,"city":333,"state":326,"zip":334,"country":69,"geoPoint":335},"Robert Wood Johnson University Hospital","New Brunswick","08901",{"lat":336,"lon":337},40.48622,-74.45182,{"facility":339,"city":340,"state":341,"zip":342,"country":69,"geoPoint":343},"Presbyterian Hospital","Albuquerque","New Mexico","87106",{"lat":344,"lon":345},35.08449,-106.65114,{"facility":347,"city":348,"state":348,"zip":349,"country":69,"geoPoint":350},"Mount Sinai Hospital","New York","10029",{"lat":351,"lon":352},40.71427,-74.00597,{"facility":354,"city":348,"state":348,"zip":355,"country":69,"geoPoint":356},"Columbia University Medical Center\u002FNYPH","10032",{"lat":351,"lon":352},{"facility":358,"city":348,"state":348,"zip":359,"country":69,"geoPoint":360},"Montefiore Medical Center - Moses Division","10467",{"lat":351,"lon":352},{"facility":362,"city":363,"state":348,"zip":364,"country":69,"geoPoint":365},"St. Francis Hospital","Roslyn","11576",{"lat":366,"lon":367},40.79982,-73.65096,{"facility":369,"city":370,"state":371,"zip":372,"country":69,"geoPoint":373},"Mission Health & Hospitals","Asheville","North Carolina","28801",{"lat":374,"lon":375},35.60095,-82.55402,{"facility":377,"city":378,"state":371,"zip":379,"country":69,"geoPoint":380},"East Carolina Heart Institute","Greenville","27834",{"lat":381,"lon":382},35.61266,-77.36635,{"facility":384,"city":385,"state":386,"zip":387,"country":69,"geoPoint":388},"The Christ Hospital","Cincinnati","Ohio","45219",{"lat":389,"lon":390},39.12711,-84.51439,{"facility":392,"city":393,"state":386,"zip":394,"country":69,"geoPoint":395},"The Cleveland Clinic","Cleveland","44195",{"lat":396,"lon":397},41.4995,-81.69541,{"facility":399,"city":400,"state":386,"zip":401,"country":69,"geoPoint":402},"Ohio Health Research Institute","Columbus","43113",{"lat":403,"lon":404},39.96118,-82.99879,{"facility":406,"city":407,"state":408,"zip":409,"country":69,"geoPoint":410},"Hillcrest Medical Center","Tulsa","Oklahoma","74104",{"lat":411,"lon":412},36.15398,-95.99277,{"facility":414,"city":415,"state":416,"zip":417,"country":69,"geoPoint":418},"Pinnacle Health System","Mechanicsburg","Pennsylvania","17055",{"lat":419,"lon":420},40.21426,-77.00859,{"facility":422,"city":423,"state":416,"zip":424,"country":69,"geoPoint":425},"Allegheny General Hospital - ASRI","Pittsburgh","15212",{"lat":426,"lon":427},40.44062,-79.99589,{"facility":429,"city":423,"state":416,"zip":430,"country":69,"geoPoint":431},"University of Pittsburgh Medical Center","15232",{"lat":426,"lon":427},{"facility":433,"city":434,"state":416,"zip":435,"country":69,"geoPoint":436},"Lankenau Institute for Medical Research","Wynnewood","19096",{"lat":437,"lon":438},40.00289,-75.27074,{"facility":440,"city":441,"state":442,"zip":443,"country":69,"geoPoint":444},"North Central Heart","Sioux Falls","South Dakota","57108",{"lat":445,"lon":446},43.54369,-96.72796,{"facility":448,"city":449,"state":450,"zip":451,"country":69,"geoPoint":452},"Baptist Memorial Hospital","Memphis","Tennessee","38120",{"lat":453,"lon":454},35.14953,-90.04898,{"facility":456,"city":457,"state":450,"zip":458,"country":69,"geoPoint":459},"Vanderbilt University Medical Center","Nashville","37232",{"lat":460,"lon":461},36.16589,-86.78444,{"facility":463,"city":464,"state":465,"zip":466,"country":69,"geoPoint":467},"Ascension Texas Cardiovascular","Austin","Texas","78705",{"lat":468,"lon":469},30.26715,-97.74306,{"facility":471,"city":464,"state":465,"zip":472,"country":69,"geoPoint":473},"Austin Heart","78756",{"lat":468,"lon":469},{"facility":475,"city":476,"state":465,"zip":477,"country":69,"geoPoint":478},"University of Texas Southwestern Medical Center","Dallas","75390",{"lat":479,"lon":480},32.78306,-96.80667,{"facility":482,"city":483,"state":465,"zip":484,"country":69,"geoPoint":485},"Houston Methodist","Houston","77030",{"lat":486,"lon":487},29.76328,-95.36327,{"facility":489,"city":483,"state":465,"zip":484,"country":69,"geoPoint":490},"UTHealth Memorial Hermann",{"lat":486,"lon":487},{"facility":492,"city":493,"state":465,"zip":494,"country":69,"geoPoint":495},"Baylor Scott & White - The Heart Hospital Plano","Plano","75093",{"lat":496,"lon":497},33.01984,-96.69889,{"facility":499,"city":500,"state":501,"zip":502,"country":69,"geoPoint":503},"Intermountain Health St George Regional Hospital","St. George","Utah","84790",{"lat":504,"lon":505},37.10415,-113.58412,{"facility":507,"city":508,"state":509,"zip":510,"country":69,"geoPoint":511},"University of Virginia Medical Center","Charlottesville","Virginia","22908",{"lat":512,"lon":513},38.02931,-78.47668,{"facility":515,"city":516,"state":509,"zip":517,"country":69,"geoPoint":518},"Sentara Norfolk General Hospital","Norfolk","23507",{"lat":519,"lon":520},36.84681,-76.28522,{"facility":522,"city":523,"state":524,"zip":525,"country":69,"geoPoint":526},"Swedish Medical Center","Seattle","Washington","98122",{"lat":527,"lon":528},47.60621,-122.33207,{"facility":530,"city":531,"state":532,"zip":533,"country":69,"geoPoint":534},"West Virginia University","Morgantown","West Virginia","26506",{"lat":535,"lon":536},39.62953,-79.9559,{"facility":538,"city":539,"state":540,"zip":541,"country":69,"geoPoint":542},"Aurora Medical Group","Milwaukee","Wisconsin","53215",{"lat":543,"lon":544},43.0389,-87.90647,{"facility":546,"city":547,"state":548,"zip":549,"country":550,"geoPoint":551},"John Hunter Hospital","Newcastle","New South Wales","2300","Australia",{"lat":552,"lon":553},-32.92953,151.7801,{"facility":555,"city":556,"state":557,"zip":558,"country":550,"geoPoint":559},"Royal Adelaide Hospital","Adelaide","Saustrl","5000",{"lat":560,"lon":561},-34.92866,138.59863,{"facility":563,"city":564,"state":565,"zip":566,"country":550,"geoPoint":567},"Monash Health","Clayton","Victoria","3168",{"lat":568,"lon":569},-37.91667,145.11667,{"facility":571,"city":572,"state":565,"zip":573,"country":550,"geoPoint":574},"The Alfred Hospital","Melbourne","3004",{"lat":575,"lon":576},-37.814,144.96332,{"facility":578,"city":579,"state":580,"zip":581,"country":582,"geoPoint":583},"St. Paul's Hospital","Vancouver","British Columbia","V6E 1M7","Canada",{"lat":584,"lon":585},49.24966,-123.11934,{"facility":587,"city":588,"state":589,"zip":590,"country":582,"geoPoint":591},"University of Ottawa Heart Institute","Ottawa","Ontario","K1Y 4W7",{"lat":592,"lon":593},45.41117,-75.69812,{"facility":595,"city":596,"state":589,"zip":597,"country":582,"geoPoint":598},"St. Michael's Hospital","Toronto","M5B 1W8",{"lat":599,"lon":600},43.70643,-79.39864,{"facility":602,"city":603,"state":604,"zip":605,"country":582,"geoPoint":606},"Institut de Cardiologie de Montreal (Montreal Heart Inst.)","Montreal","Quebec","H1T 1C8",{"lat":607,"lon":608},45.50884,-73.58781,{"facility":610,"city":603,"state":604,"zip":611,"country":582,"geoPoint":612},"The Royal Victoria Hospital","H4A3J1",{"lat":607,"lon":608},{"facility":614,"city":615,"zip":616,"country":582,"geoPoint":617},"Saint John Regional Hospital - New Brunswick Heart Centre","Saint John","NB E2L 4L4",{"lat":618,"lon":619},45.27076,-66.05616,{"facility":621,"city":622,"state":623,"zip":624,"country":625,"geoPoint":626},"Hopital Haut Leveque","Pessac","AQT","33600","France",{"lat":627,"lon":628},44.80565,-0.6324,{"facility":630,"city":631,"state":632,"zip":633,"country":625,"geoPoint":634},"CHU Rennes, Pontchaillou","Rennes","Brittan","35033",{"lat":635,"lon":636},48.11109,-1.67431,{"facility":638,"city":639,"state":640,"zip":641,"country":625,"geoPoint":642},"Clinique Pasteur Toulouse","Toulouse","Midpyre","31076",{"lat":643,"lon":644},43.60426,1.44367,{"facility":646,"city":647,"state":648,"zip":649,"country":650,"geoPoint":651},"St.-Johannes Hospital","Dortmund","N. RHIN","44137","Germany",{"lat":652,"lon":653},51.51494,7.466,{"facility":655,"city":656,"state":657,"zip":658,"country":659,"geoPoint":660},"Shaare Zedek Medical Center","Jerusalem","Jeruslm","9103102","Israel",{"lat":661,"lon":662},31.76904,35.21633,{"facility":664,"city":665,"state":666,"zip":667,"country":668,"geoPoint":669},"Universitair Medisch Centrum Groningen","Groningen","Grogen","9713 GZ","Netherlands",{"lat":670,"lon":671},53.21917,6.56667,{"facility":673,"city":674,"state":674,"zip":675,"country":676,"geoPoint":677},"Basel University Hospital","Basel","4031","Switzerland",{"lat":678,"lon":679},47.55839,7.57327,[],[682,686,690,693,697],{"name":683,"affiliation":684,"role":685},"Haresh Sachanandani","Abbott Structural Heart","STUDY_DIRECTOR",{"name":687,"affiliation":688,"role":689},"Michael Reardon, MD","The Methodist Hospital Research Institute","STUDY_CHAIR",{"name":691,"affiliation":692,"role":689},"Azeem Azeem, MD","Montefiore Medical Center",{"name":694,"affiliation":695,"role":696},"Bassem Chehab, MD","Ascension Via Christi Hospitals","PRINCIPAL_INVESTIGATOR",{"name":698,"role":696},"Ibrahim Sultan, MD",[],[],{"nct_id":4,"conditions":702,"biomarkers":705},[703,19,704],"Aortic Valve Disorder","Bioprosthetic Aortic Valve Failure",[],{"nct_id":4,"found":55,"summary":54,"prompt_version":54}]