[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05172973":3,"trial-entities:NCT05172973":342,"trial-summary:NCT05172973":345},{"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":21,"study_type":26,"primary_purpose":27,"phases":28,"enrollment_info":30,"interventions":33,"primary_outcomes":41,"secondary_outcomes":46,"sex":58,"minimum_age":59,"maximum_age":59,"healthy_volunteers":60,"eligibility_criteria":61,"std_ages":65,"locations":69,"central_contacts":329,"overall_officials":335,"references":340,"see_also_links":341},"NCT05172973","2021-05-AVIV","ALLIANCE AVIV: Safety and Effectiveness of the SAPIEN X4 Transcatheter Heart Valve in Failing Aortic Bioprosthetic Valves","Safety and Effectiveness of Balloon-Expandable Bioprosthetic SAPIEN X4 Transcatheter Heart Valve in Failing Aortic Bioprosthetic Valves","RECRUITING","2039-12","2026-06","2026-07-27","2023-11-22","Edwards Lifesciences","INDUSTRY",true,"The objective of this study is to establish the safety and effectiveness of the Edwards SAPIEN X4\u002FX4S Transcatheter Heart Valve (THV) in subjects who are at high or greater risk with a failing aortic bioprosthetic valve.","Prospective, single arm, multicenter study",[19,20],"Aortic Valve Insufficiency","Aortic Valve Stenosis",[22,23,24,25],"Transcatheter aortic valve replacement (TAVR)","Transcatheter aortic valve implantation (TAVI)","SAPIEN X4\u002FX4S","Valve-in-valve","INTERVENTIONAL","TREATMENT",[29],"NA",{"count":31,"type":32},200,"ESTIMATED",[34],{"type":35,"name":36,"description":37,"armGroupLabels":38},"DEVICE","SAPIEN X4\u002FX4S THV","Implantation of the SAPIEN X4\u002FX4S valve",[39,40],"Transcatheter Aortic Valve Replacement (TAVR) - Surgical Valve","Transcatheter Aortic Valve Replacement (TAVR) - THV",[42],{"measure":43,"description":44,"timeFrame":45},"Non-hierarchical composite of death and stroke","The number of patients that died or had a stroke","1 year",[47,51,53,56],{"measure":48,"description":49,"timeFrame":50},"Kansas City Cardiomyopathy Questionnaire (KCCQ) score","The KCCQ is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. An overall summary score can be derived from the physical function, symptom (frequency and severity), social function and quality of life domains. Scores are transformed to a range of 0-100, in which higher scores reflect better health status.","30 days",{"measure":52,"timeFrame":45},"KCCQ score",{"measure":54,"description":55,"timeFrame":50},"New York Heart Association (NYHA) functional class","NYHA is a functional classification of heart failure based on how much a patient is limited during physical activity. The rating ranges from I - IV, with the lowest (I) as no limitations and the highest (IV) unable to carry on any physical activity without discomfort.",{"measure":57,"timeFrame":45},"NYHA functional class","ALL",null,false,{"inclusion":62,"exclusion":63,"raw_text":64},[],[],"Inclusion Criteria:\n\n1. Failing aortic bioprosthetic valve demonstrating ≥ moderate stenosis and\u002For ≥ moderate insufficiency\n2. Bioprosthetic valve size suitable for SAPIEN X4 THV\n3. NYHA functional class ≥ II\n4. Heart Team agrees the subject is at high or greater surgical risk\n5. The subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.\n\nExclusion Criteria:\n\n1. Anatomical characteristics that would preclude safe femoral placement of the introducer sheath or safe passage of the delivery system\n2. Failing valve has moderate or severe paravalvular regurgitation\n3. Failing valve is unstable, rocking, or not structurally intact\n4. Known severe patient-prosthesis mismatch or bioprosthetic valve with residual mean gradient \\> 20 mmHg at the end of the index procedure for implantation of the original valve\n5. Increased risk of THV embolization\n6. Surgical or transcatheter valve in the mitral position\n7. Severe mitral regurgitation (\\> 3+) or ≥ moderate mitral stenosis\n8. Need for mitral, tricuspid or pulmonic valve intervention within the next 12 months\n9. Left ventricular ejection fraction \\\u003C 20%\n10. Cardiac imaging evidence of intracardiac mass, thrombus or vegetation\n11. Increased risk of coronary artery obstruction after THV implantation\n12. Myocardial infarction within 30 days prior to the study procedure\n13. Hypertrophic cardiomyopathy with subvalvular obstruction\n14. Subjects with planned concomitant ablation for atrial fibrillation\n15. Clinically significant coronary artery disease requiring revascularization\n16. Any surgical or transcatheter procedure within 30 days prior to the study procedure. Implantation of a permanent pacemaker or implantable cardioverter defibrillator is not considered an exclusion.\n17. Any planned surgical or transcatheter intervention to be performed within 30 days following the study procedure\n18. Endocarditis within 180 days prior to the study procedure\n19. Stroke, transient ischemic attack or neurological signs and symptoms attributed to carotid or vertebrobasilar disease within 90 days prior to the study procedure\n20. Hemodynamic or respiratory instability requiring inotropic or mechanical support within 30 days prior to the study procedure\n21. Renal insufficiency and\u002For renal replacement therapy\n22. Leukopenia, anemia, thrombocytopenia\n23. Inability to tolerate or condition precluding treatment with antithrombotic therapy\n24. Hypercoagulable state or other condition that increases risk of thrombosis\n25. Absolute contraindications or allergy to iodinated contrast that cannot be adequately treated with premedication\n26. Subject refuses blood products\n27. Body mass index \\> 50 kg\u002Fm2\n28. Estimated life expectancy \\\u003C 24 months\n29. Female who is pregnant or lactating\n30. Active SARS-CoV-2 infection or previously diagnosed with COVID-19 with sequelae that could confound endpoint assessments\n31. Participating in another investigational drug or device study that has not reached its primary endpoint\n32. Subject considered to be part of a vulnerable population",[66,67,68],"CHILD","ADULT","OLDER_ADULT",[70,79,86,90,97,105,113,121,125,133,140,148,156,164,172,180,188,195,202,210,216,220,224,230,238,241,249,256,264,272,280,288,295,304,313,321],{"facility":71,"status":8,"city":72,"state":73,"zip":74,"country":75,"geoPoint":76},"Hoag Memorial Hospital Presbyterian","Newport Beach","California","92663","United States",{"lat":77,"lon":78},33.61891,-117.92895,{"facility":80,"status":8,"city":81,"state":73,"zip":82,"country":75,"geoPoint":83},"Bay Area Structural Heart at Sutter Health","San Francisco","94105",{"lat":84,"lon":85},37.77493,-122.41942,{"facility":87,"status":8,"city":81,"state":73,"zip":88,"country":75,"geoPoint":89},"Kaiser San Francisco","94115",{"lat":84,"lon":85},{"facility":91,"status":8,"city":92,"state":73,"zip":93,"country":75,"geoPoint":94},"Stanford University Medical Center","Stanford","94305",{"lat":95,"lon":96},37.42411,-122.16608,{"facility":98,"status":8,"city":99,"state":100,"zip":101,"country":75,"geoPoint":102},"UC Health Medical Center of the Rockies","Loveland","Colorado","80538",{"lat":103,"lon":104},40.39776,-105.07498,{"facility":106,"status":8,"city":107,"state":108,"zip":109,"country":75,"geoPoint":110},"Naples Community Hospital Healthcare System","Naples","Florida","34102",{"lat":111,"lon":112},26.14234,-81.79596,{"facility":114,"status":8,"city":115,"state":116,"zip":117,"country":75,"geoPoint":118},"Emory University Atlanta","Atlanta","Georgia","30308",{"lat":119,"lon":120},33.749,-84.38798,{"facility":122,"status":8,"city":115,"state":116,"zip":123,"country":75,"geoPoint":124},"Piedmont Heart Institute","30309",{"lat":119,"lon":120},{"facility":126,"status":8,"city":127,"state":128,"zip":129,"country":75,"geoPoint":130},"Northwestern University Chicago","Evanston","Illinois","60208",{"lat":131,"lon":132},42.04114,-87.69006,{"facility":134,"status":8,"city":135,"state":128,"zip":136,"country":75,"geoPoint":137},"Alexian Brothers Hospital Network","Lisle","60532",{"lat":138,"lon":139},41.80114,-88.07479,{"facility":141,"status":8,"city":142,"state":143,"zip":144,"country":75,"geoPoint":145},"Cardiovascular Research Institute of Kansas","Wichita","Kansas","67226",{"lat":146,"lon":147},37.69224,-97.33754,{"facility":149,"status":8,"city":150,"state":151,"zip":152,"country":75,"geoPoint":153},"MedStar Union Memorial Hospital","Baltimore","Maryland","21218",{"lat":154,"lon":155},39.29038,-76.61219,{"facility":157,"status":8,"city":158,"state":159,"zip":160,"country":75,"geoPoint":161},"Brigham and Women's Hospital","Boston","Massachusetts","02115",{"lat":162,"lon":163},42.35843,-71.05977,{"facility":165,"status":8,"city":166,"state":167,"zip":168,"country":75,"geoPoint":169},"Henry Ford Hospital Detroit","Detroit","Michigan","48202",{"lat":170,"lon":171},42.33143,-83.04575,{"facility":173,"status":8,"city":174,"state":175,"zip":176,"country":75,"geoPoint":177},"Mayo Clinic","Rochester","Minnesota","55905",{"lat":178,"lon":179},44.02163,-92.4699,{"facility":181,"status":8,"city":182,"state":183,"zip":184,"country":75,"geoPoint":185},"Atlantic Health System Morristown","Morristown","New Jersey","07960",{"lat":186,"lon":187},40.79677,-74.48154,{"facility":189,"status":8,"city":190,"state":183,"zip":191,"country":75,"geoPoint":192},"Robert Wood Johnson University Hospital","New Brunswick","08901",{"lat":193,"lon":194},40.48622,-74.45182,{"facility":196,"status":8,"city":197,"state":183,"zip":198,"country":75,"geoPoint":199},"The Valley Hospital","Ridgewood","07450",{"lat":200,"lon":201},40.97926,-74.11653,{"facility":203,"status":8,"city":204,"state":205,"zip":206,"country":75,"geoPoint":207},"University of Buffalo","Buffalo","New York","14203",{"lat":208,"lon":209},42.88645,-78.87837,{"facility":211,"status":8,"city":205,"state":205,"zip":212,"country":75,"geoPoint":213},"Cornelll University New York","10021",{"lat":214,"lon":215},40.71427,-74.00597,{"facility":217,"status":8,"city":205,"state":205,"zip":218,"country":75,"geoPoint":219},"Columbia University Medical Center \u002F NYPH","10032",{"lat":214,"lon":215},{"facility":221,"status":8,"city":205,"state":205,"zip":222,"country":75,"geoPoint":223},"Montefiore Medical Center","10458",{"lat":214,"lon":215},{"facility":225,"status":8,"city":174,"state":205,"zip":226,"country":75,"geoPoint":227},"Rochester General Hospital","14621",{"lat":228,"lon":229},43.15478,-77.61556,{"facility":231,"status":8,"city":232,"state":233,"zip":234,"country":75,"geoPoint":235},"Carolinas Health System","Charlotte","North Carolina","28204",{"lat":236,"lon":237},35.22709,-80.84313,{"facility":239,"status":8,"city":232,"state":233,"zip":234,"country":75,"geoPoint":240},"Novant Health and Vascular Institute",{"lat":236,"lon":237},{"facility":242,"status":8,"city":243,"state":244,"zip":245,"country":75,"geoPoint":246},"The Christ Hospital","Cincinnati","Ohio","45219",{"lat":247,"lon":248},39.12711,-84.51439,{"facility":250,"status":8,"city":251,"state":244,"zip":252,"country":75,"geoPoint":253},"The Cleveland Clinic Foundation","Cleveland","44195",{"lat":254,"lon":255},41.4995,-81.69541,{"facility":257,"status":8,"city":258,"state":259,"zip":260,"country":75,"geoPoint":261},"Oklahoma Heart Institute","Tulsa","Oklahoma","74104",{"lat":262,"lon":263},36.15398,-95.99277,{"facility":265,"status":8,"city":266,"state":267,"zip":268,"country":75,"geoPoint":269},"Allegheny General Hospital","Pittsburgh","Pennsylvania","15212",{"lat":270,"lon":271},40.44062,-79.99589,{"facility":273,"status":8,"city":274,"state":275,"zip":276,"country":75,"geoPoint":277},"Saint Thomas Health","Nashville","Tennessee","37205",{"lat":278,"lon":279},36.16589,-86.78444,{"facility":281,"status":8,"city":282,"state":283,"zip":284,"country":75,"geoPoint":285},"University of Texas Memorial Hermann","Houston","Texas","77030",{"lat":286,"lon":287},29.76328,-95.36327,{"facility":289,"status":8,"city":290,"state":283,"zip":291,"country":75,"geoPoint":292},"The Heart Hospital Baylor Plano","Plano","75093",{"lat":293,"lon":294},33.01984,-96.69889,{"facility":296,"status":297,"city":298,"state":299,"zip":300,"country":75,"geoPoint":301},"University of Washington Seattle","WITHDRAWN","Seattle","Washington","98195",{"lat":302,"lon":303},47.60621,-122.33207,{"facility":305,"status":8,"city":306,"state":307,"zip":308,"country":309,"geoPoint":310},"St. Paul's Hospital Vancouver","Vancouver","British Columbia","V6Z1Y6","Canada",{"lat":311,"lon":312},49.24966,-123.11934,{"facility":314,"status":8,"city":315,"state":316,"zip":317,"country":309,"geoPoint":318},"Hamilton Health Sciences","Hamilton","Ontario","L8L 2X2",{"lat":319,"lon":320},43.25011,-79.84963,{"facility":322,"status":8,"city":323,"state":324,"zip":325,"country":309,"geoPoint":326},"Institut Universitaire de Cardiologie et de Pneumologie de Québec- Universite Laval","Québec","Quebec","G1V4G5",{"lat":327,"lon":328},46.81228,-71.21454,[330],{"name":331,"role":332,"phone":333,"email":334},"Edwards THV Clinical Affairs","CONTACT","949-250-2500","THV_CT.gov@Edwards.com",[336],{"name":337,"affiliation":338,"role":339},"Robert Cubbedu, MD","Naples Community Hospital","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":343,"biomarkers":344},[19,20],[],{"nct_id":4,"found":15,"summary":346,"prompt_version":356},{"design":347,"status":348,"heading":349,"summary":350,"follow_up":351,"word_count":352,"commitments":353,"compensation":354,"drugs_mentioned":355},"This is a single-arm study, meaning all participants will receive the SAPIEN X4\u002FX4S THV. It is planned to include 200 participants across multiple centers.","completed","SAPIEN X4 Transcatheter Heart Valve for Failing Aortic Valves","This study is testing the safety and effectiveness of the SAPIEN X4\u002FX4S Transcatheter Heart Valve (THV) in people whose existing aortic bioprosthetic valve is failing. You might be able to join if your current valve has moderate or worse narrowing (stenosis) or leaking (insufficiency), and your heart team believes surgery is too risky for you. The study will look at how many people experience death or stroke within one year after receiving the SAPIEN X4\u002FX4S THV. This study aims to enroll about 200 participants, but its current recruitment status is unclear.","The study will track participants for at least one year to measure outcomes like death and stroke.",91,"Not specified in the trial record.","Not stated in the trial record.",[36],"v2"]